Obesity
Conditions
Keywords
phentermine, Hypoglycemic agents, Incretins, Hormones, Appetitive Behavior, Appetite Depressants, Anti-Obesity Agents, Weight Loss, Body Weight, Body Weight Changes, Signs and Symptoms
Brief summary
This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).
Detailed description
Subjects will be a total of 150 adults, aged 21-70 years, with a body mass index (BMI) of 31 kg/m2 or above (28 kg/m2 with an obesity-related comorbidity). In phase 1, eligible subjects will complete questionnaires and an in-person baseline assessment of obesity-related behavioral characteristics (satiety, hunger, the relative reinforcing value of food \[RRVfood\], and impulsivity \[delay discounting\]), neuropeptides, and gastric emptying. After this baseline assessment, participants will begin an initial 4-week behavioral treatment (BT) run-in delivered individually in 20-30 minute weekly sessions (delivered virtually). The primary goal of phase 1 will be to evaluate baseline satiety, postprandial change in GLP-1, and gastric emptying as predictors of percent weight loss after 4 weeks of BT. We will also examine whether these variables predict categorization as a suboptimal early responder to BT (e.g., \<2.0% loss; co-primary outcome). Secondary endpoints of phase 1 are percent weight loss from the start of the BT run-in (week -4) to randomization (week 0) and categorization as a suboptimal early responder, as predicted by additional behavioral characteristics (hunger as measured by VAS ratings, RRVfood as measured using a computer task, and impulsivity as measured using a delay discounting computer task) and neuropeptides (higher fasting ghrelin, lower fasting leptin, and lower postprandial changes in insulin and PYY). In phase 2, suboptimal early responders (based on weight loss during the BT run-in) will be randomly assigned to 24 weeks of: 1) BT plus placebo (BT+P); or 2) BT plus medication (BT+M; phentermine 15.0 mg). Both treatment groups will continue to attend 20-30 minute individual BT sessions (delivered virtually), weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits). Both treatment groups will also take once daily study medication (placebo or phentermine 15.0 mg) for the duration of the intervention period. Early BT responders identified during the run-in will receive the same 24-week BT program, but will not receive study medication or be included in the randomized trial. The assessments administered at baseline - questionnaires, including behavioral testing, blood draws, and measurements of body weight - will be repeated at randomization (week 0) and at week 24. The primary endpoint of phase 2 is change in body weight (i.e., % reduction in initial weight), as measured from randomization to week 24, among suboptimal early responders assigned to BT+P vs. BT+M. A randomized sample size of 50 non-responders (25 per group), assuming a 20% attrition rate, will give us 81.5% power to detect between-treatment group differences at week 24 of 4.5% (effect size: d = 0.82). Secondary endpoints of phase 2 will include change in body weight in kg from randomization to week 24, as well as the portion of suboptimal early responders who achieve a post-randomization loss of ≥ 5% and ≥ 10% of initial body weight. We will also examine differences between suboptimal early responders treated with BT+M vs. BT+P in changes in hunger, satiety, the reinforcing efficacy of food, and impulsivity between randomization and week 24. A comparison will also be made in percent weight loss from randomization to week 24 between suboptimal early responders treated with BT+M and early responders treated with BT alone. If you are interested in participating in this study, information and a link to contact the research team can be found here: https://clinicalresearch.itmat.upenn.edu/3XOX/ or you can call us at the numbers listed below.
Interventions
BEHAVIORALBehavioral Treatment
Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
DRUGPlacebo
The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Phase 1 is observational. Phase 2 is a double-blind, placebo-controlled, randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. BMI ≥ 31 kg/m² (or 28 kg/m2 with obesity-related comorbidity) 2. Age ≥ 21 years and ≤ 70 years 3. Eligible female patients will be: * non-pregnant, evidenced by a negative urine pregnancy test * non-lactating * surgically sterile or postmenopausal, or they will agree to continue to use an accepted method of birth control during the study. Acceptable methods of birth control are: hormonal contraceptives; double barrier method (condom with spermicide or diaphragm with spermicide); intrauterine device; surgical sterility; abstinence; and/or postmenopausal status (defined as at least 2 years without menses). 4. Subjects must: * have a primary care provider (PCP) who is responsible for providing routine care * understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent * plan to remain in the Philadelphia area for the next 9 months or more
Exclusion criteria
1. Pregnant or nursing, or plans to become pregnant in the next 9 months. 2. Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg) 3. Type 1 diabetes 4. Type 2 diabetes 5. A fasting blood glucose \> 126 mg/dL (on second assessment after first elevated value) 6. History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, or heart block greater than first degree 7. Clinically significant hepatic or renal disease 8. Hyperthyroidism 9. Other thyroid disease, not controlled 10. History of malignancy (except for non-melanoma skin cancer) in past 5 years 11. Narrow angle glaucoma 12. Presence or history of marked agitation 13. Current severe major depressive episode (BDI-II score ≥ 29), current active suicidal ideation, or history of suicide attempts within the past 5 years. 14. Any severity of thought or bipolar disorder, or bulimia nervosa. 15. Psychiatric hospitalization within the past 6 months 16. Self-reported alcohol or substance abuse within the past 6 months, including at-risk drinking (current consumption of ≥ 14 alcoholic drinks per week) 17. Past year history of drug abuse 18. Use in the past 2 weeks of monoamine oxidase inhibitors 19. Current use of serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g. venlafaxine, duloxetine, desvenlafaxine, milnacipran, levomilnacipran). 20. Use in past 6 months of medications known to induce significant weight loss (i.e., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics) 21. Loss of ≥ 5% of initial body weight within the past 6 months 22. History of (or plans for) bariatric surgery (e.g., roux en y gastric bypass, sleeve gastrectomy, gastric banding), endoscopic intragastric balloon, or aspire assist. 23. Inability to walk 5 blocks comfortably or engage in some other form of aerobic activity (e.g., swimming) 24. Known or suspected allergy to sympathomimetic amines or related products 25. The receipt of any investigational drug within 6 months prior to this trial 26. Previous participation in this trial (e.g., randomized and failed to participate) 27. Changes to any chronic medication (type or dosage) within the past 3 months. 28. Any serious or unstable medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the study Other Therapy: Subjects will be expected to use medications (prescribed by their PCP) to control traditional cardiometabolic risk factors (e.g., hypertension, hypercholesterolemia, etc) and other co-morbid conditions, with the exception of medications listed above under exclusions. In all cases, the subjects' PCP will be asked at the study's outset to keep medication does constant throughout the study, whenever possible. Subjects will be expected to have been on their medication regimen (including the dose) for 3 months prior to beginning the BT program. To be eligible to participate in the randomized phase of the trial, subjects must also: 1. Complete at least 3 out of 4 treatment sessions during the 4-week BT run-in and attend a randomization visit. Attending an in-person makeup session within one week of a missed visit will count as having attended the run-in visit. 2. Lose \< 2.0% of initial weight during the 4-week BT run-in. Early BT responders who lose\>=2% during the BT run-in will be offered the same 24-week BT program, but will not receive study medication or be included in the randomized trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Percent Weight Loss | Week -4 (start of BT run-in) to week 0 (randomization) | Co-primary outcomes - phase 1 |
| Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss | Week -4 (start of BT run-in) to week 0 (randomization) | Co-primary outcomes - phase 1 |
| Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100. | Baseline (week -5) | Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety. |
| Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal | Baseline | Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i. |
| Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test) | Baseline | Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i. |
| Phase 2: Percent Weight Loss | Week 0 (randomization) to week 24 | Primary outcomes - phase 2 Percent change from randomization in body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1: Baseline Postprandial Change in Insulin During a Test Meal | Baseline | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i. |
| Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal | Baseline | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i. |
| Phase 2: Weight Loss (kg) | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 |
| Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24 | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 |
| Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal | Baseline | Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the hunger scale score at time i. |
| Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i. |
| Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the scale score at time i. |
| Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. |
| Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24 | Week 0 (randomization) to week 24 | Secondary outcomes - phase 2 |
| Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned | Baseline | Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum. |
| Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Baseline | Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i. |
| Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Baseline | Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite. |
| Phase 1: Baseline Fasting Ghrelin | Baseline | Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL) |
| Phase 1: Baseline Fasting Leptin | Baseline | Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Phase 2: Change in Triglycerides | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2 |
| Phase 2: Change in HDL and LDL Cholesterol | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2. Reported here is HDL |
| Phase 2: Change in Fasting Blood Sugar | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2. Fasting glucose. |
| Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale | Baseline | Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness |
| Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL) | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24. |
| Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9) | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24. |
| Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24. |
| Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, appetite was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. |
| Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale | Baseline | Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food) |
| Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS) | Baseline | Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness |
| Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | Baseline | Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger) |
| Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency) | Baseline | Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, appetite was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite. |
| Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | Baseline | The potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1. |
| Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced | Baseline | Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings |
| Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ) | Baseline | Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating |
| Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012) | Baseline | Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers. |
| Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL) | Baseline | Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy |
| Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES) | Baseline | Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy |
| Phase 1: Randomization Ball and Crawford Social Support Scale | Randomization (week 0) | Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support. |
| Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS) | Baseline | Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms |
| Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food | Baseline | Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price. |
| Phase 1: Baseline Sleep Hours Survey | Baseline | Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep |
| Phase 1: Baseline Perceived Stress Scale | Baseline | Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress |
| Phase 1: Baseline Anxiety as Measured by the GAD-7 | Baseline | Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety |
| Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale | Baseline | Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance. |
| Phase 2: Change in Blood Pressure (Systolic) | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2. Systolic blood pressure |
| Phase 2: Change in Pulse | Week 0 (randomization) to week 24 | Exploratory outcomes - phase 2. Pulse |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from July 2019 to November 2021. No participants could be enrolled between March 15, 2020 and July 1, 2020 due to COVID-19.
Pre-assignment details
147 pts consented & enrolled in phase 1. Of those, 16 did not enroll in phase 2: 7 did not complete \>=3 BT sessions, 5 could not complete a randomization visit due to COVID-19, 3 were lost to follow-up and 1 declined. 55 pts were early responders. For clinical purposes, these pts continued to receive BT for 24 weeks but because they were not eligible for randomization they were not part of the RCT. 76 pts were early non-responders (4-week weight loss \< 2%) randomized to BT+ placebo or BT+ med
Participants by arm
| Arm | Count |
|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in All enrolled participants will complete an initial 4-week behavioral treatment (BT) run-in. This run-in will be used to identify early non-responders to BT, defined by a weight loss \<2% of initial weight after 4 weeks of BT. Early responders are those who lose \>=2%.
Behavioral Treatment: Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
Note: Data represent the baseline characteristics of all enrolled participants at the start of phase 1 (week -4). Only 76 participants were later eligible to enroll in the randomized trial. | 147 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 1: 4-week Non-randomized BT run-in | Could not complete visit due to COVID-19 | 5 | 0 | 0 |
| Phase 1: 4-week Non-randomized BT run-in | Lost to Follow-up | 8 | 0 | 0 |
| Phase 2: Randomized Trial | Lost to Follow-up | 0 | 2 | 2 |
Baseline characteristics
| Characteristic | Phase 1: 4-week Behavioral Treatment Run-in |
|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 12.4 |
| BMI (kg/m2) | 37.7 kg/m2 STANDARD_DEVIATION 6.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 57 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight (kg) | 104.6 kg STANDARD_DEVIATION 19.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 147 | 0 / 38 | 0 / 38 | 0 / 55 |
| other Total, other adverse events | 23 / 147 | 27 / 38 | 23 / 38 | 20 / 55 |
| serious Total, serious adverse events | 0 / 147 | 0 / 38 | 0 / 38 | 0 / 55 |
Outcome results
Primary
Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)
Primary predictor variable - phase 1 Gastric emptying was measured as the 60-minute area under the curve (AUC) for acetaminophen in micrograms per milliliter (ug/mL). Blood samples were obtained at time 0 (fasting/no acetaminophen - confirmatory) and 30 and 60-min after ingestion. Because acetaminophen is minimally absorbed by the stomach but quickly enters the bloodstream in the small intestine, gastric emptying is considered to be the primary factor influencing its appearance in the blood. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the acetaminophen value in ug/mL at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 13 participants for whom we could not obtain at least one postprandial blood sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test) | 5.22 ug/mL*hr | Standard Deviation 3.39 |
p-value: 0.78Regression, Linear
Primary
Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal
Primary predictor variable - phase 1. Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for GLP-1 in picomoles (pM). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the GLP-1 value in pM at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal | 0.52 pM*hr | Standard Deviation 0.46 |
p-value: 0.34Regression, Linear
Primary
Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100.
Primary predictor variable - phase 1 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The satiety quotient was then calculated for each post-preload rating using the above formula (see measure title). More positive scores show increased satiety (more appetite suppression). The final analysis uses the 60-minute area under the curve (AUC) for the satiety quotient to predict phase 1 weight loss outcomes. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the satiety quotient value at time i. Higher scores indicate higher sustained satiety.
Time frame: Baseline (week -5)
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to participants whose VAS responses at baseline were not complete enough to be scored.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100. | 787.3 Satiety quotient*min | Standard Deviation 684.9 |
p-value: 0.24Regression, Linear
Primary
Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss
Co-primary outcomes - phase 1
Time frame: Week -4 (start of BT run-in) to week 0 (randomization)
Population: 16 were not enrolled in Phase 2: 7 did not complete at least 3 BT sessions 5 could not complete a randomization visit due to COVID-19 3 were lost to follow-up~1 declined randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss | 76 Participants |
Primary
Phase 1: Percent Weight Loss
Co-primary outcomes - phase 1
Time frame: Week -4 (start of BT run-in) to week 0 (randomization)
Population: Percent weight loss at the end of the 4-week BT run-in (phase 1) for all 134 individuals who provided a weight measurement at the end of the run-in (week 0) and for the subset of 76 individuals who were categorized as early non-responders and then enrolled in the randomized trial (phase 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Percent Weight Loss | 1.7 % change in weight | Standard Deviation 1.6 |
| Behavioral Treatment + Placebo | Phase 1: Percent Weight Loss | 0.9 % change in weight | Standard Deviation 0.9 |
| Behavioral Treatment + Medication | Phase 1: Percent Weight Loss | 0.3 % change in weight | Standard Deviation 1.1 |
Primary
Phase 2: Percent Weight Loss
Primary outcomes - phase 2 Percent change from randomization in body weight
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Percent Weight Loss | 2.8 % change in weight | Standard Error 0.7 |
| Behavioral Treatment + Placebo | Phase 2: Percent Weight Loss | 5.9 % change in weight | Standard Error 0.7 |
p-value: 0.00395% CI: [1.1, 5.1]Mixed Models Analysis
Secondary
Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay
Secondary predictor variable - phase 1 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | 0.34 dollar*day | Standard Deviation 0.23 |
p-value: 0.033Regression, Linear
Secondary
Phase 1: Baseline Fasting Ghrelin
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting). Active ghrelin. Unit: Picograms per milliliter (pg/mL)
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain a fasting blood sample or for whom fasting ghrelin results were out of range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Fasting Ghrelin | 75.65 pg/mL | Standard Deviation 64.08 |
p-value: 0.73Regression, Linear
Secondary
Phase 1: Baseline Fasting Leptin
Secondary predictor variable - phase 1 Unit: Picograms per milliliter (pg/mL) Blood samples were drawn at time 0 (fasting).
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 10 participants for whom we could not obtain a fasting blood sample or whose sample results were out of range.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Fasting Leptin | 46980.6 pg/mL | Standard Deviation 38772.3 |
Comparison: Correlation between baseline fasting leptin and 4-week percent weight loss.p-value: 0.25Regression, Linear
Secondary
Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal
Secondary predictor variable - phase 1 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min area under the curve (AUC) for postprandial change in hunger at baseline.(more negative = more sustained reduction in hunger). Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the hunger scale score at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher = More Hunger) During a Test Meal | -770.97 score on a scale*min | Standard Deviation 1272.98 |
p-value: 0.23Regression, Linear
Secondary
Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire
Secondary predictor variable - phase 1 Implicit wanting is measured by the Leeds Food Preference Questionnaire, a computer-based task using a forced choice paradigm for four categories: High-fat savory, high-fat sweet, low-fat savory, low-fat sweet. Reaction times are transformed to a standardized D-score that is then adjusted for the frequency of selection using a validated algorithm. Scores can range from -100 to 100 with more positive scores indicating a more rapid preference for one category over the other and more negative scores indicating the opposite.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 2 participants due to their not completing the LFPQ at their baseline assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Implicit wanting of low-fat savory | -13.5 Scale score | Standard Deviation 23.6 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Implicit wanting of low-fat sweet | 18.7 Scale score | Standard Deviation 28.1 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Implicit wanting of high-fat savory | 7.0 Scale score | Standard Deviation 26.9 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Implicit Wanting, Reaction Time on Leeds Food Preference Questionnaire | Implicit wanting of high-fat sweet | -12.2 Scale score | Standard Deviation 27.7 |
p-value: 0.04Regression, Linear
Comparison: Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included taughter in the same analysis, so separate correlations were conducted.p-value: 0.72Regression, Linear
Comparison: Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.p-value: 0.94Regression, Linear
Comparison: Correlation between baseline implicit wanting and 4-week percent weight loss. Because categories are scored relative to each other they cannot be included together in the same analysis, so separate correlations were conducted.p-value: 0.09Regression, Linear
Secondary
Phase 1: Baseline Postprandial Change in Insulin During a Test Meal
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Incremental area under the curve in insulin measured in micro-international units per milliliter (ulU/mL). Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the insulin value in ulU/mL at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Postprandial Change in Insulin During a Test Meal | 20.96 ulU/mL*hr | Standard Deviation 13.08 |
p-value: 0.72Regression, Linear
Secondary
Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal
Secondary predictor variable - phase 1 Blood samples were drawn at time 0 (fasting) and 30- and 60-min postprandial samples after consumption of a test meal. Value presented below is the 60-minute incremental area under the curve (AUC) for PYY in picograms per milliliter (pgmL) at baseline. Area under the curve is calculated using the trapezoidal rule to sum the area under each 0.5-hour interval. AUC = Σ i = 0 to i = 1 0.5hr\*(x(i) + x(i-1))/2) where x is the PYY value in pg/mL at time i.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 14 participants for whom we could not obtain at least one postprandial blood sample and/or a fasting blood sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Postprandial Change in Peptide YY During a Test Meal | 7.44 pg/mL*hr | Standard Deviation 7.15 |
p-value: 0.82Regression, Linear
Secondary
Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned
Secondary predictor variable - phase 1 Subjects are allowed to work to earn points from a slot machine task at either of two computer stations, one of which provides points towards obtaining a serving of a preferred high-calorie food, and the other points towards a preferred low-calorie food. Points are earned on a progressive ratio scale that increases at fixed intervals. The primary outcome is the number of reinforcer points (servings) earned for the high energy density food, which is thought to reflect the subject's willingness to allocate time and effort to obtaining desired high-calorie foods. The minimum number of points that can be earned is 0; there is no specified maximum.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). An additional 5 participants had missing data for this task at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Relative Reinforcing Value of Food (Computer Task), Number of Food Reinforcer Points Earned | 1.85 Points (portions) earned | Standard Deviation 1.23 |
p-value: 0.23Regression, Linear
Secondary
Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal
Secondary outcomes - phase 2 Appetite suppression was first calculated as the average of 100 mm VAS items: hunger (reverse score), satisfaction, fullness, and prospective consumption (reverse score), such that higher scores indicate more appetite suppression (less appetite) for each test meal rating (fasting, then every 10m for 60m). The final analysis uses the 60-minute incremental area under the curve (AUC) for change in appetite suppression from fasting. Higher scores indicate higher sustained appetite suppression. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the appetite suppression value at time i.
Time frame: Week 0 (randomization) to week 24
Population: Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Week 24 | 862.8 mm*min | Standard Deviation 890.7 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Randomization | 1167.7 mm*min | Standard Deviation 1124.8 |
| Behavioral Treatment + Placebo | Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Randomization | 1357.5 mm*min | Standard Deviation 1345.3 |
| Behavioral Treatment + Placebo | Phase 2: Change in Appetite Suppression, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal | Week 24 | 1245.3 mm*min | Standard Deviation 1072.9 |
Secondary
Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay
Secondary outcomes - phase 2 Delay discounting is assessed via a computer program in which subjects are offered choices between small, immediate monetary rewards and larger, delayed rewards. The present delay discounting computer task used 7 time delays for $1000. The outcome is the area under the curve (AUC) representing the ratio of immediate reward size to time delay. AUCs were standardized to fall between 0 and 1 (Myerson et al., 2001) and were calculated for the plot of subjective values vs. delay, with lower values indicating greater discounting. Area under the curve is calculated using the trapezoidal rule to sum the area under each standardized time interval. AUC = Σ i = 0 to i = 1 proportion of max delay\*(x(i) + x(i-1))/2) where x is the proportion of the maximum price inflection value at time i.
Time frame: Week 0 (randomization) to week 24
Population: Randomized participants who completed the study (N = 71 of 76) and also completed the delay discounting assessment at week 24 (N = 63 of 71).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Randomization | 0.41 dollar*day | Standard Deviation 0.3 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Week 24 | 0.42 dollar*day | Standard Deviation 0.31 |
| Behavioral Treatment + Placebo | Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Week 24 | 0.38 dollar*day | Standard Deviation 0.25 |
| Behavioral Treatment + Placebo | Phase 2: Change in Delay Discounting (Computer Task), Area Under the Curve Representing the Ratio of Immediate Reward Size to Time Delay | Randomization | 0.38 dollar*day | Standard Deviation 0.29 |
p-value: 0.68ANCOVA
Secondary
Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal
Secondary outcomes - phase 2 Hunger was rated before and at 10 min intervals after a test meal for 60 min. Data presented below are the 60-min incremental area under the curve (AUC) for postprandial change in hunger at randomization and week 24. More negative scores indicate greater sustained reductions in hunger from fasting. Area under the curve is calculated using the trapezoidal rule to sum the area under each 10-minute interval. AUC = Σ i = 0 to i = 60 10min\*(x(i) + x(i-1))/2) where x is the scale score at time i.
Time frame: Week 0 (randomization) to week 24
Population: Randomized participants who completed the study (N = 71 of 76) and also completed the appetite test meal assessment at week 24 (N = 63 of 71). An additional two placebo-treated participants provided appetite ratings, but incremental area under the curve could not be calculated due to missing fasting item data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Randomization | -1062.5 mm*min | Standard Deviation 1139.8 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Week 24 | -579.5 mm*min | Standard Deviation 1530.6 |
| Behavioral Treatment + Placebo | Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Randomization | -1113.2 mm*min | Standard Deviation 1294.6 |
| Behavioral Treatment + Placebo | Phase 2: Change in Hunger, as Measured by Visual Analogue Scales (Range 0-100 mm, Higher=More Hunger) During a Test Meal | Week 24 | -935.2 mm*min | Standard Deviation 1336.9 |
Secondary
Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24
Secondary outcomes - phase 2
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24 | 2 Participants |
| Behavioral Treatment + Placebo | Phase 2: Number of Participants With a Weight Loss of 10% or Greater of Randomization Body Weight at Week 24 | 6 Participants |
Secondary
Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24
Secondary outcomes - phase 2
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24 | 8 Participants |
| Behavioral Treatment + Placebo | Phase 2: Number of Participants With a Weight Loss of 5% or Greater of Randomization Body Weight at Week 24 | 20 Participants |
Secondary
Phase 2: Weight Loss (kg)
Secondary outcomes - phase 2
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Weight Loss (kg) | 2.6 kg | Standard Error 0.7 |
| Behavioral Treatment + Placebo | Phase 2: Weight Loss (kg) | 5.7 kg | Standard Error 0.7 |
p-value: 0.00295% CI: [1.1, 5]Mixed Models Analysis
Other Pre-specified
Phase 1: Baseline Anxiety as Measured by the GAD-7
Exploratory predictor variable - phase 1 Anxiety as measured by the GAD-7, sum of 7 items, range 0-28, higher scores indicate more anxiety
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Anxiety as Measured by the GAD-7 | 4.4 Scale score | Standard Deviation 4.5 |
Other Pre-specified
Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency)
Exploratory predictor variable - phase 1 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, appetite was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm, Higher=Greater Amount or Frequency) | 50.7 mm | Standard Deviation 12 |
p-value: 0.31Regression, Linear
Other Pre-specified
Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder
The potential presence or absence of binge eating disorder (BED) is determined based on the participant's responses to questions assessing DSM-5 criteria for the disorder. Participants are categorized as potentially having BED, potentially having subthreshold BED (meets all criteria except frequency) or unlikely to have BED based on questionnaire responses. Exploratory predictor variable - phase 1.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | Potential BED | 17 Participants |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | Potential subthreshold BED | 6 Participants |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Binge Eating as Measured by The Questionnaire on Eating and Weight Patterns (QEWP-5); Measure Categorizes Participants Based on Whether They May Meet Diagnostic Criteria for Binge Eating Disorder | Unlikely to have BED | 108 Participants |
Other Pre-specified
Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced
Exploratory predictor variable - phase 1 The Food Craving Q Trait - Reduced, total score (sum of 15 items, range 15-90); higher scores indicate more food cravings
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Craving Frequency as Measured by the Food Craving Q Trait - Reduced | 42.9 Scale score | Standard Deviation 15.9 |
Other Pre-specified
Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger)
Exploratory predictor variable - phase 1 The Eating Inventory (EI); Dietary restraint subscale (scored 0-21 higher=more restraint), Disinhibition sub scale (scored 0-16 higher=more disinhibition), Hunger sub scale (scored 0-14 higher=more hunger)
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Eating Inventory scores for an additional 4 participants could not be calculated due to missing items
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | EI Dietary Restraint | 9.2 score on a scale | Standard Deviation 3.7 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | EI Disinhibition | 8.9 score on a scale | Standard Deviation 3.3 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Eating Behavior as Measured by The Eating Inventory (EI); Dietary Restraint Subscale (Scored 0-21 Higher=More Restraint), Disinhibition Sub Scale (Scored 0-16 Higher=More Disinhibition), Hunger Sub Scale (Scored 0-14 Higher=More Hunger) | EI Hunger | 5.9 score on a scale | Standard Deviation 3.3 |
p-value: 0.75Regression, Linear
Other Pre-specified
Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ)
Exploratory predictor variable - phase 1 The Dutch Eating Behaviour Questionnaire (DEBQ) Emotional Eating subscale, mean of 13 items, range 1-5, higher scores indicate more emotional eating
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Emotional Eating as Measured by the Dutch Eating Behaviour Questionnaire (DEBQ) | 2.7 Scale score | Standard Deviation 1 |
Other Pre-specified
Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS)
Exploratory predictor variable - phase 1 The YFAS symptom count (continuous outcome) total score was used for the present data, symptom score range 0-11, higher scores indicate more food addiction symptoms
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Additional missing data were attributable to missing item responses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Food Addiction Using the Yale Food Addiction Scale (YFAS) | 2.4 Symptom count | Standard Deviation 2.4 |
Other Pre-specified
Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale
Exploratory predictor variable - phase 1 Two separate subscales were scored: mindful awareness and acceptance, range 1-5 for both subscales. Higher scores indicate more awareness or acceptance.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale | Awareness | 3.6 score on a scale | Standard Deviation 3.5 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline General Mindfulness and Acceptance as Measured Using the Philadelphia Mindfulness Scale | Acceptance | 3.1 score on a scale | Standard Deviation 0.8 |
Other Pre-specified
Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale
Exploratory predictor variable - phase 1 BIS-15, range 15-60, higher= more impulsiveness
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the BIS-15 scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Impulsivity as Measured by The Barratt Impulsiveness Scale | 28.7 Scale score | Standard Deviation 6.5 |
p-value: 0.76Regression, Linear
Other Pre-specified
Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012)
Exploratory predictor variable - phase 1 Data presented are for the total score taken as the sum of all 40 items, range 40-200. Higher total scores indicate more perceived barriers.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 4 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Perceived Barriers to Healthy Eating and Physical Activity (Scale by Welsh et al., 2012) | 112.7 Scale score | Standard Deviation 25.4 |
Other Pre-specified
Phase 1: Baseline Perceived Stress Scale
Exploratory predictor variable - phase 1 Total score on the Perceived Stress Scale, sum of 10 items, range 0-40, higher scores indicate more perceived stress
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Perceived Stress Scale | 15.8 Scale score | Standard Deviation 6.9 |
Other Pre-specified
Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale
Exploratory predictor variable - phase 1 Power of Food Scale (PFS; range 1-5, higher=greater power of food)
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 6 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Reinforcing Value of Food as Measured by the Power of Food Scale | 2.7 Scale score | Standard Deviation 0.9 |
Other Pre-specified
Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES)
Exploratory predictor variable - phase 1 SCI Exercise Self Efficacy Scale (ESES) total score, sum of 10 items, range 10-40, higher scores indicate greater exercise-related self-efficacy
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline SCI Exercise Self Efficacy Scale (ESES) | 30.6 Scale score | Standard Deviation 5.3 |
Other Pre-specified
Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS)
Exploratory predictor variable - phase 1 BIS subscale range 7-28, higher = greater inhibition; BAS reward responsiveness sub scale range 5-20, higher=greater reward responsiveness
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 5 participants due to missing items on the BIS-BAS scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS) | BIS Total | 14.2 Scale score | Standard Deviation 4 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Sensitivity to Reward as Measured by the Behavioral Inhibition/Activation Scale (BIS/BAS) | BAS Reward | 8.2 Scale score | Standard Deviation 2.2 |
p-value: 0.03Regression, Linear
Other Pre-specified
Phase 1: Baseline Sleep Hours Survey
Exploratory predictor variable - phase 1 Average hours slept per night, including weekday and weekend nights, potential range 0 - 24, higher scores indicate more sleep
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Sleep Hours Survey | 7.0 hours slept per night | Standard Deviation 1 |
Other Pre-specified
Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL)
Exploratory predictor variable - phase 1 Weight Efficacy Life-Style Questionnaire (WEL), sum of 8 items, range 0-80, higher scores indicate greater weight-related self-efficacy
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 3 participants due to missing items on the scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Baseline Weight Efficacy Life-Style Questionnaire (WEL) | 44.4 Scale score | Standard Deviation 16.8 |
Other Pre-specified
Phase 1: Randomization Ball and Crawford Social Support Scale
Exploratory predictor variable - phase 1 Four subscales: positive social support for eating, negative social support for eating, positive social support for exercise, and negative social support for exercise were scored separately for family and for friends. Participants rated these individuals support during the 4-week BT run-in. Participants were instructed not to answer items if not applicable. Each subscale has a range of 1-5 with higher scores indicating more positive/negative social support.
Time frame: Randomization (week 0)
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). Participants were instructed not to answer items if not applicable to their household/lifestyle, resulting in fewer ppts completing this scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Randomization Ball and Crawford Social Support Scale | positive eating support from family | 2.8 score on a scale | Standard Deviation 1.2 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Randomization Ball and Crawford Social Support Scale | negative eating support from family | 2.4 score on a scale | Standard Deviation 0.9 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Randomization Ball and Crawford Social Support Scale | positive exercise support from family | 2.1 score on a scale | Standard Deviation 1 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: Randomization Ball and Crawford Social Support Scale | negative exercise support from family | 1.2 score on a scale | Standard Deviation 0.4 |
Other Pre-specified
Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food
Exploratory predictor variable - phase 1 Questionnaire version of the relative reinforcing value of food computer task in which participants were asked how many servings of a preferred snack food they would consume in 1 week if they had access to no other snack foods for that week and could not stockpile for a later date. They complete this question at different price levels of the food and the reported score is the elasticity of demand which is the slope of the relationship between price (log) and number of servings that the person would purchase. Scores typically range between 0 and -2, though lower scores are theoretically possible. More negative values indicate larger reductions in purchasing of the snack food for each increase in price.
Time frame: Baseline
Population: mITT analysis was planned to include all participants who provided at least one post-baseline weight measurement (N=139 out of 147). We could not include an additional 9 participants due to missing items on the scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food | High energy density snack | -0.99 (log)dollar/purchased serving | Standard Deviation 0.21 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 1: The Reinforcing Efficacy of High- and Low-calorie Food | Low energy density snack | -1.03 (log)dollar/purchased serving | Standard Deviation 0.21 |
Other Pre-specified
Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm)
Exploratory outcomes - phase 2 Appetite was rated weekly using the Control of Eating Questionnaire. Participants were asked to rate items based on their appetite in the past week. For the present analysis, appetite was calculated as the mean of the ratings for hunger, fullness after meals (reversed), and thoughts about wanting food. Higher scores (Range 0 - 100) indicate greater past-week appetite.
Time frame: Week 0 (randomization) to week 24
Population: Randomized participants who completed the study (N = 71 of 76) and also completed the COEQ at week 24 (N = 65).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Randomization | 48.5 mm | Standard Deviation 14.3 |
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Week 24 | 47.5 mm | Standard Deviation 16.8 |
| Behavioral Treatment + Placebo | Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Randomization | 53.3 mm | Standard Deviation 13.8 |
| Behavioral Treatment + Placebo | Phase 2: Change in Appetite Ratings (Ratings of Appetite During the Past Week Using Visual Analogue Scales, Scored 0-100 mm) | Week 24 | 42.7 mm | Standard Deviation 14.4 |
Other Pre-specified
Phase 2: Change in Blood Pressure (Systolic)
Exploratory outcomes - phase 2. Systolic blood pressure
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Blood Pressure (Systolic) | -0.7 mm Hg | Standard Error 1.84 |
| Behavioral Treatment + Placebo | Phase 2: Change in Blood Pressure (Systolic) | 6.6 mm Hg | Standard Error 1.86 |
Other Pre-specified
Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9)
Exploratory outcomes - phase 2 Sum of 9 items, possible range 0-27. Lower scores are better (less depression). Negative values below for change in this measure represent improvement from randomization to week 24.
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9) | -0.68 units on a scale | Standard Error 0.55 |
| Behavioral Treatment + Placebo | Phase 2: Change in Depressive Symptoms as Measured by the Patient Health Questionnaire (PHQ-9) | -0.75 units on a scale | Standard Error 0.54 |
Other Pre-specified
Phase 2: Change in Fasting Blood Sugar
Exploratory outcomes - phase 2. Fasting glucose.
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Fasting Blood Sugar | 1.00 mg/dL | Standard Error 1.81 |
| Behavioral Treatment + Placebo | Phase 2: Change in Fasting Blood Sugar | -0.66 mg/dL | Standard Error 1.93 |
Other Pre-specified
Phase 2: Change in HDL and LDL Cholesterol
Exploratory outcomes - phase 2. Reported here is HDL
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in HDL and LDL Cholesterol | 3.27 mg/dL | Standard Error 1.49 |
| Behavioral Treatment + Placebo | Phase 2: Change in HDL and LDL Cholesterol | 1.52 mg/dL | Standard Error 1.37 |
Other Pre-specified
Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire
Exploratory outcomes - phase 2 Outcome from this measure is activity minutes per week. Potential range 0 - 10,080 min/week. Higher scores indicate more minutes of activity per week. Positive values below for change in this measure represent improvement from randomization to week 24.
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire | 29.90 minutes per week | Standard Error 34.02 |
| Behavioral Treatment + Placebo | Phase 2: Change in Physical Activity Using the Paffenbarger Physical Activity Questionnaire | 91.85 minutes per week | Standard Error 34.85 |
Other Pre-specified
Phase 2: Change in Pulse
Exploratory outcomes - phase 2. Pulse
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Pulse | 0.09 BPM | Standard Error 1.56 |
| Behavioral Treatment + Placebo | Phase 2: Change in Pulse | 3.96 BPM | Standard Error 1.5 |
Other Pre-specified
Phase 2: Change in Triglycerides
Exploratory outcomes - phase 2
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Triglycerides | -9.00 mg/dL | Standard Error 7.45 |
| Behavioral Treatment + Placebo | Phase 2: Change in Triglycerides | -16.00 mg/dL | Standard Error 7.25 |
Other Pre-specified
Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL)
Exploratory outcomes - phase 2 Impact of Weight on Quality of Life (IWQOL) scale scores are transformed to a t-score ranging from 0-100 (e.g., 50 indicates the population mean with a standard deviation of 10). Higher t-scores are better. Positive values below for change in this measure represent improvement from randomization to week 24.
Time frame: Week 0 (randomization) to week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1: 4-week Behavioral Treatment Run-in | Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL) | 7.56 t score | Standard Error 2.18 |
| Behavioral Treatment + Placebo | Phase 2: Change in Weight-related Quality of Life as Measured by the Impact of Weight on Quality of Life (IWQOL) | 9.77 t score | Standard Error 2.17 |