Obesity
Conditions
Keywords
Weight Loss, Weight Stigma, Physical Activity, Cardiovascular Risk Factor
Brief summary
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.
Interventions
BEHAVIORALStigma-Reduction Intervention
Session topics will be based on those tested in a previous pilot study, including: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to physical activity. For example, they will be given strategies to cope with anticipated stigma while exercising in public spaces (e.g., while walking), as well as to challenge self-critical beliefs (e.g., that they are lazy) which may otherwise lead them to avoid exercising. These concrete strategies, along with reducing WBI and improving self-confidence, are intended to increase participants' self-efficacy for and engagement in physical activity.
BEHAVIORALBehavioral Weight Loss (BWL)
This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants \< 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are \>10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants will be men and women ages 18 years and older. * Participants must have obesity, defined as a BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with an obesity-related comorbidity. o Obesity-related comorbidities (which confer added CVD risk) will include: * coronary heart disease; * other atherosclerotic disease; * sleep apnea; * hypercholesteremia (i.e., high cholesterol, as diagnosed by doctor and/or if taking medication to lower cholesterol); * and components of the metabolic syndrome, including hypertension (SBP ≥130, DBP ≥80 mm Hg, diagnosed by doctor and/or if taking anti-hypertensive medication); fasting blood glucose of 100-125 mg/dL (or prediabetes, diagnosed by doctor),; low HDL cholesterol (\<40 mg/dL in men, \<50 mg/dL in women), elevated triglycerides (\>150 mg/dL, i.e., dyslipidemia diagnosed by doctor or taking medication to treat dyslipidemia), or elevated waist circumference (≥40 in for men, ≥35 in for women),. * Eligible participants must also report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview, and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview. * Participants must be seeking weight loss. * If currently taking medications, dosages must be stable for at least 3 months. * Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables. * Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months. Eligible female patients will be: * non-pregnant and non-lactating * surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study Participants must: * have a PCP who is responsible for providing routine care * have reliable telephone service and/or email access with which to be in contact with the study team * understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Exclusion criteria
Applicants will be excluded if they have: * a diagnosis of type I or II diabetes (for type II diabetes, blood glucose ≥126 mg/dL or A1C ≥6.5); * uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg); * experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months; * lost and maintained ≥ 5% of their initial weight in the last 3 months or ≥ 10% in the past 2 years; * or have participated in individual or group psychotherapy related to weight in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). o Participants who have recently received or are currently receiving therapy for a pre-existing mental health issue unrelated to weight (e.g., psychotherapy for depression or anxiety, or marriage, grief, or career counseling) may be eligible if the therapy is deemed by the Principal Investigator to be unlikely to affect weight, eating habits, or physical activity. * Applicants with severe symptoms of mood (BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. o Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion. * Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated. * Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area. * Applicants will not be eligible if they have a history of bariatric surgery. * Women who are nursing, pregnant, or planning to become pregnant in the next 16 months are not eligible to participate. * Applicants who report obtaining 150 minutes or more of structured physical activity per week (e.g., 30 minutes 5 days per week) will not be eligible, as they will already be obtaining the recommended amount of physical activity and may not be able to further increase their activity as part of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Weight Change at Week 72 | Baseline to week 72 | Estimated mean percent change in weight from baseline to week 72 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission of Elevated Weight Bias Internalization at Week 72 | Baseline to week 72 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) |
| Percent Weight Change at Week 46 | Baseline to week 46 | Estimated mean percent weight change |
| Percent Weight Change at Week 20 | Baseline to week 20 | Estimated mean percent weight change |
| Loss of 5% or Greater of Initial Body Weight at Week 46 | Baseline to week 46 | The percentage of participants who lost 5% or greater of their initial body weight at week 46 |
| Loss of 10% or Greater of Initial Body Weight at Week 46 | Baseline to week 46 | The percentage of participants who lost 10% or greater of their initial body weight at week 46 |
| Loss of 5% or Greater of Initial Body Weight at Week 20 | Baseline to week 20 | The percentage of participants who lost 5% or greater of their initial body weight at week 20 |
| Loss of 10% or Greater of Initial Body Weight at Week 20 | Baseline to week 20 | The percentage of participants who lost 10% or greater of their initial body weight at week 20 |
| Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Baseline to week 72 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry |
| Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Baseline to week 46 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry |
| Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Baseline to week 20 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry |
| Change in Energy Expenditure at Week 72 | Baseline to week 72 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. |
| Change in Energy Expenditure at Week 46 | Baseline to week 46 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. |
| Change in Energy Expenditure at Week 20 | Baseline to week 20 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. |
| Change in Exercise Self-efficacy at Week 72 | Baseline to week 72 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) |
| Change in Exercise Self-efficacy at Week 46 | Baseline to week 46 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) |
| Change in Exercise Self-efficacy at Week 20 | Baseline to week 20 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) |
| Change in Eating Self-efficacy at Week 72 | Baseline to week 72 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) |
| Change in Eating Self-efficacy at Week 46 | Baseline to week 46 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) |
| Change in Eating Self-efficacy at Week 20 | Baseline to week 20 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) |
| Change in Triglycerides at Week 72 | Baseline to week 72 | Estimated mean change in triglyceride concentration in blood |
| Change in Triglycerides at Week 20 | Baseline to week 20 | Estimated mean change in triglyceride concentration in blood |
| Change in Blood Pressure at Week 72 | Baseline to week 72 | Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg) |
| Change in Blood Pressure Week 20 | Baseline to week 20 | Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg) |
| Change in Weight Bias Internalization Scale Score at Week 72 | Baseline to week 72 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization). |
| Change in Weight Bias Internalization Scale Score at Week 46 | Baseline to week 46 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) |
| Change in Weight Bias Internalization Scale Score at Week 20 | Baseline to week 20 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) |
| Remission of Elevated Weight Bias Internalization at Week 46 | Baseline to week 46 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) |
| Remission of Elevated Weight Bias Internalization at Week 20 | Baseline to week 20 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) |
| Change in Weight Self-stigma Scores at Week 72 | Baseline to week 72 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. |
| Change in Weight Self-stigma Scores at Week 46 | Baseline to week 46 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. |
| Change in Weight Self-stigma Scores at Week 20 | Baseline to week 20 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. |
| Treatment Acceptability at Week 20 | Week 20 | To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability. |
| Treatment Acceptability at Week 72 | Week 72 | To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability. |
| Loss of 5% or Greater of Initial Body Weight at Week 72 | Baseline to week 72 | The percentage of participants who lost 5% or greater of their initial body weight at week 72 |
| Loss of 10% or Greater of Initial Body Weight at Week 72 | Baseline to week 72 | The percentage of participants who lost 10% or greater of their initial body weight at week 72 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Minutes of Sedentary Time at Week 20 | Baseline to week 20 | Single item from Global Physical Activity Questionnaire (minutes) |
| Change in High-density Lipoprotein (HDL) Cholesterol at Week 72 | Baseline to week 72 | Concentration in blood, controlling for medication use |
| Change in High-density Lipoprotein (HDL) Cholesterol at Week 20 | Baseline to week 20 | Concentration in blood, controlling for medication use |
| Change in Waist Circumference at Week 72 | Baseline to week 72 | — |
| Change in Waist Circumference at Week 20 | Baseline to week 20 | — |
| Change in Blood Glucose at Week 72 | Baseline to week 72 | Concentration in blood, controlling for medication use |
| Change in Blood Glucose at Week 20 | Baseline to week 20 | Concentration in blood, controlling for medication use |
| Change in C-reactive Protein at Week 72 | Baseline to week 72 | Concentration in blood |
| Change in C-reactive Protein at Week 20 | Baseline to week 20 | Concentration in blood |
| Change in Stereotype Endorsement Scores at Week 72 | Baseline to week 72 | Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias) |
| Change in Stereotype Endorsement Scores at Week 46 | Baseline to week 46 | Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias) |
| Change in Stereotype Endorsement Scores at Week 20 | Baseline to week 20 | Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias) |
| Change in Weight-related Quality of Life at Week 72 | Baseline to week 72 | Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life) |
| Change in Weight-related Quality of Life at Week 46 | Baseline to week 46 | Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life) |
| Change in Weight-related Quality of Life at Week 20 | Baseline to week 20 | Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life) |
| Change in Perceived Stress at Week 72 | Baseline to week 72 | Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress) |
| Change in Perceived Stress at Week 46 | Baseline to week 46 | Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress) |
| Change in Perceived Stress at Week 20 | Baseline to week 20 | Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress) |
| Change in Depression Symptoms at Week 72 | Baseline to week 72 | Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression) |
| Change in Depression Symptoms at Week 46 | Baseline to week 46 | Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression) |
| Change in Depression Symptoms at Week 20 | Baseline to week 20 | Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression) |
| Change in Body Image Scores at Week 72 | Baseline to week 72 | Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation) |
| Change in Body Image Scores at Week 46 | Baseline to week 46 | Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation) |
| Change in Body Image Scores at Week 20 | Baseline to week 20 | Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation) |
| Change in Presence and Frequency of Binge Eating at Week 72 | Baseline to week 72 | Questionnaire on Eating and Weight Patterns (yes/no and episodes per week) |
| Change in Presence and Frequency of Binge Eating at Week 46 | Baseline to week 46 | Questionnaire on Eating and Weight Patterns (yes/no and episodes per week) |
| Change in Presence and Frequency of Binge Eating at Week 20 | Baseline to week 20 | Questionnaire on Eating and Weight Patterns (yes/no and episodes per week) |
| Change in Self-monitoring Behaviors at Week 72 | Baseline to week 72 | Food records and self-report recording of food intake and physical activity |
| Change in Self-monitoring Behaviors at Week 46 | Baseline to week 46 | Food records and self-report recording of food intake and physical activity |
| Change in Self-monitoring Behaviors at Week 20 | Baseline to week 20 | Food records and self-report recording of food intake and physical activity |
| Change in Minutes of Sedentary Time at Week 46 | Baseline to week 46 | Single item from Global Physical Activity Questionnaire (minutes) |
| Change in Minutes of Sedentary Time at Week 72 | Baseline to week 72 | Single item from Global Physical Activity Questionnaire (minutes) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stigma + BWL Intervention Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity. | 52 |
| Standard BWL Intervention Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation. | 53 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Censoring event | 1 | 0 |
| Overall Study | Lost to Follow-up | 8 | 4 |
| Overall Study | No longer available for study visits | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Age, Continuous | 48.96 years STANDARD_DEVIATION 12.86 | 49.15 years STANDARD_DEVIATION 12.05 | 49.06 years STANDARD_DEVIATION 12.4 |
| Body mass index (BMI) | 38.23 kg/m^2 STANDARD_DEVIATION 5.59 | 37.48 kg/m^2 STANDARD_DEVIATION 5.16 | 37.85 kg/m^2 STANDARD_DEVIATION 5.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 50 Participants | 102 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 165.04 cm STANDARD_DEVIATION 7.13 | 166.35 cm STANDARD_DEVIATION 7.87 | 165.70 cm STANDARD_DEVIATION 7.51 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 14 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Female | 49 Participants | 46 Participants | 95 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 10 Participants |
| Weight | 104.39 kg STANDARD_DEVIATION 18.21 | 104.48 kg STANDARD_DEVIATION 21.04 | 104.44 kg STANDARD_DEVIATION 19.59 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 53 |
| other Total, other adverse events | 14 / 52 | 17 / 53 |
| serious Total, serious adverse events | 0 / 52 | 0 / 53 |
Outcome results
Primary
Percent Weight Change at Week 72
Estimated mean percent change in weight from baseline to week 72
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Percent Weight Change at Week 72 | -7.16 percent weight change | Standard Error 0.95 |
| Standard BWL Intervention | Percent Weight Change at Week 72 | -5.19 percent weight change | Standard Error 0.92 |
p-value: 0.14Mixed Models Analysis
Secondary
Change in Blood Pressure at Week 72
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Time frame: Baseline to week 72
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Blood Pressure at Week 72 | Systolic Blood Pressure | -5.0 mmHg | Standard Error 1.7 |
| Stigma + BWL Intervention | Change in Blood Pressure at Week 72 | Diastolic Blood Pressure | -1.9 mmHg | Standard Error 1.1 |
| Standard BWL Intervention | Change in Blood Pressure at Week 72 | Systolic Blood Pressure | -5.6 mmHg | Standard Error 1.8 |
| Standard BWL Intervention | Change in Blood Pressure at Week 72 | Diastolic Blood Pressure | -2.0 mmHg | Standard Error 1.1 |
Comparison: Systolic Blood Pressurep-value: 0.8Mixed Models Analysis
Comparison: Diastolic Blood Pressurep-value: 0.94Mixed Models Analysis
Secondary
Change in Blood Pressure Week 20
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Time frame: Baseline to week 20
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Blood Pressure Week 20 | Systolic Blood Pressure | -9.7 mmHG | Standard Error 1.7 |
| Stigma + BWL Intervention | Change in Blood Pressure Week 20 | Diastolic Blood Pressure | -3.5 mmHG | Standard Error 1.1 |
| Standard BWL Intervention | Change in Blood Pressure Week 20 | Systolic Blood Pressure | -5.4 mmHG | Standard Error 1.6 |
| Standard BWL Intervention | Change in Blood Pressure Week 20 | Diastolic Blood Pressure | -3.6 mmHG | Standard Error 1.1 |
Comparison: Systolic Blood Pressurep-value: 0.07Mixed Models Analysis
Comparison: Diastolic Blood Pressurep-value: 0.96Mixed Models Analysis
Secondary
Change in Eating Self-efficacy at Week 20
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Eating Self-efficacy at Week 20 | 12.3 score on a scale | Standard Error 2.4 |
| Standard BWL Intervention | Change in Eating Self-efficacy at Week 20 | 8.6 score on a scale | Standard Error 2.3 |
p-value: 0.27Mixed Models Analysis
Secondary
Change in Eating Self-efficacy at Week 46
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Time frame: Baseline to week 46
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Eating Self-efficacy at Week 46 | 5.8 score on a scale | Standard Error 2.4 |
| Standard BWL Intervention | Change in Eating Self-efficacy at Week 46 | -1.0 score on a scale | Standard Error 2.4 |
p-value: 0.045Mixed Models Analysis
Secondary
Change in Eating Self-efficacy at Week 72
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Eating Self-efficacy at Week 72 | 6.5 score on a scale | Standard Error 2.5 |
| Standard BWL Intervention | Change in Eating Self-efficacy at Week 72 | 1.7 score on a scale | Standard Error 2.4 |
p-value: 0.16Mixed Models Analysis
Secondary
Change in Energy Expenditure at Week 20
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Energy Expenditure at Week 20 | 452.5 Kcal | Standard Error 111.9 |
| Standard BWL Intervention | Change in Energy Expenditure at Week 20 | 289.3 Kcal | Standard Error 105.6 |
p-value: 0.27Mixed Models Analysis
Secondary
Change in Energy Expenditure at Week 46
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Time frame: Baseline to week 46
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Energy Expenditure at Week 46 | 148.7 Kcal | Standard Error 90.1 |
| Standard BWL Intervention | Change in Energy Expenditure at Week 46 | 260.4 Kcal | Standard Error 103.5 |
p-value: 0.53Mixed Models Analysis
Secondary
Change in Energy Expenditure at Week 72
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Energy Expenditure at Week 72 | 314.8 Kcal | Standard Error 105.9 |
| Standard BWL Intervention | Change in Energy Expenditure at Week 72 | 307.5 Kcal | Standard Error 108 |
p-value: 0.84Mixed Models Analysis
Secondary
Change in Exercise Self-efficacy at Week 20
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Exercise Self-efficacy at Week 20 | 1.1 score on a scale | Standard Error 3.2 |
| Standard BWL Intervention | Change in Exercise Self-efficacy at Week 20 | -2.0 score on a scale | Standard Error 3.1 |
p-value: 0.48Mixed Models Analysis
Secondary
Change in Exercise Self-efficacy at Week 46
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Time frame: Baseline to week 46
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Exercise Self-efficacy at Week 46 | -10.6 score on a scale | Standard Error 3.2 |
| Standard BWL Intervention | Change in Exercise Self-efficacy at Week 46 | -15.9 score on a scale | Standard Error 3.2 |
p-value: 0.24Mixed Models Analysis
Secondary
Change in Exercise Self-efficacy at Week 72
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Exercise Self-efficacy at Week 72 | -9.4 score on a scale | Standard Error 3.3 |
| Standard BWL Intervention | Change in Exercise Self-efficacy at Week 72 | -15.0 score on a scale | Standard Error 3.2 |
p-value: 0.22Mixed Models Analysis
Secondary
Change in Minutes of Physical Activity (Accelerometer) at Week 20
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Time frame: Baseline to week 20
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | MVPA per day with 10 minute bouts | 11.4 Minutes per day | Standard Error 4 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | MVPA per day with 20 minute bouts | 10.5 Minutes per day | Standard Error 2.6 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Moderate activity per day | 10.6 Minutes per day | Standard Error 6.7 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Light activity per day | -19.0 Minutes per day | Standard Error 14.2 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Light activity per day | 3.8 Minutes per day | Standard Error 13.2 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | MVPA per day with 10 minute bouts | 8.8 Minutes per day | Standard Error 4.1 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Moderate activity per day | 4.7 Minutes per day | Standard Error 6.7 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 20 | MVPA per day with 20 minute bouts | 9.9 Minutes per day | Standard Error 2.7 |
Comparison: MVPA per day with 10 minute boutsp-value: 0.63Mixed Models Analysis
Comparison: MVPA per day with 20 minute boutsp-value: 0.72Mixed Models Analysis
Comparison: Moderate activity per dayp-value: 0.52Mixed Models Analysis
Comparison: Light activity per dayp-value: 0.27Mixed Models Analysis
Secondary
Change in Minutes of Physical Activity (Accelerometer) at Week 46
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Time frame: Baseline to week 46
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | MVPA per day with 10 minute bouts | 9.5 Minutes per day | Standard Error 4.3 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | MVPA per day with 20 minute bouts | 9.9 Minutes per day | Standard Error 3.4 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Moderate activity per day | 0.6 Minutes per day | Standard Error 7.2 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Light activity per day | -37.1 Minutes per day | Standard Error 15.9 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Light activity per day | -67.0 Minutes per day | Standard Error 16 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | MVPA per day with 10 minute bouts | 5.4 Minutes per day | Standard Error 4.4 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Moderate activity per day | -17.9 Minutes per day | Standard Error 7.2 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 46 | MVPA per day with 20 minute bouts | 10.5 Minutes per day | Standard Error 3.2 |
Comparison: MVPA per day with 10 minute boutsp-value: 0.46Mixed Models Analysis
Comparison: MVPA per day with 20 minute boutsp-value: 0.87Mixed Models Analysis
Comparison: Moderate activity per dayp-value: 0.07Mixed Models Analysis
Comparison: Light activity per dayp-value: 0.17Mixed Models Analysis
Secondary
Change in Minutes of Physical Activity (Accelerometer) at Week 72
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Time frame: Baseline to week 72
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | MVPA per day with 10 minute bouts | 9.6 Minutes per day | Standard Error 4.1 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | MVPA per day with 20 minute bouts | 9.4 Minutes per day | Standard Error 3.2 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Moderate activity per day | 3.2 Minutes per day | Standard Error 6.8 |
| Stigma + BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Light activity per day | -35.6 Minutes per day | Standard Error 15.1 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Light activity per day | -51.5 Minutes per day | Standard Error 14.3 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | MVPA per day with 10 minute bouts | 7.2 Minutes per day | Standard Error 4.1 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Moderate activity per day | -10.2 Minutes per day | Standard Error 6.7 |
| Standard BWL Intervention | Change in Minutes of Physical Activity (Accelerometer) at Week 72 | MVPA per day with 20 minute bouts | 8.4 Minutes per day | Standard Error 3.1 |
Comparison: MVPA per day with 10 minute boutsp-value: 0.62Mixed Models Analysis
Comparison: MVPA per day with 20 minute boutsp-value: 0.92Mixed Models Analysis
Comparison: Moderate activity per dayp-value: 0.16Mixed Models Analysis
Comparison: Light activity per dayp-value: 0.41Mixed Models Analysis
Secondary
Change in Triglycerides at Week 20
Estimated mean change in triglyceride concentration in blood
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Triglycerides at Week 20 | -10.9 mg/dL | Standard Error 6.3 |
| Standard BWL Intervention | Change in Triglycerides at Week 20 | -7.7 mg/dL | Standard Error 6.5 |
p-value: 0.67Mixed Models Analysis
Secondary
Change in Triglycerides at Week 72
Estimated mean change in triglyceride concentration in blood
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Triglycerides at Week 72 | -9.9 mg/dL | Standard Error 6.4 |
| Standard BWL Intervention | Change in Triglycerides at Week 72 | -13.7 mg/dL | Standard Error 6.8 |
p-value: 0.72Mixed Models Analysis
Secondary
Change in Weight Bias Internalization Scale Score at Week 20
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 20 | -1.4 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 20 | -1.2 score on a scale | Standard Error 0.1 |
p-value: 0.45Mixed Models Analysis
Secondary
Change in Weight Bias Internalization Scale Score at Week 46
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time frame: Baseline to week 46
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 46 | -1.5 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 46 | -1.4 score on a scale | Standard Error 0.1 |
p-value: 0.67Mixed Models Analysis
Secondary
Change in Weight Bias Internalization Scale Score at Week 72
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization).
Time frame: Baseline to week 72
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 72 | -1.7 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Change in Weight Bias Internalization Scale Score at Week 72 | -1.5 score on a scale | Standard Error 0.1 |
p-value: 0.3Mixed Models Analysis
Secondary
Change in Weight Self-stigma Scores at Week 20
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Time frame: Baseline to week 20
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-SD | -4.6 score on a scale | Standard Error 0.7 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-Total | -8.2 score on a scale | Standard Error 1.1 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-FE | -3.6 score on a scale | Standard Error 0.6 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-Total | -5.5 score on a scale | Standard Error 1.1 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-SD | -3.2 score on a scale | Standard Error 0.6 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 20 | WSSQ-FE | -2.3 score on a scale | Standard Error 0.6 |
Comparison: WSSQ-Totalp-value: 0.07Mixed Models Analysis
Comparison: WSSQ-SDp-value: 0.11Mixed Models Analysis
Comparison: WSSQ-FEp-value: 0.15Mixed Models Analysis
Secondary
Change in Weight Self-stigma Scores at Week 46
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Time frame: Baseline to week 46
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-Total | -8.5 score on a scale | Standard Error 1.1 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-SD | -4.0 score on a scale | Standard Error 0.7 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-FE | -4.5 score on a scale | Standard Error 0.6 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-Total | -5.5 score on a scale | Standard Error 1.1 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-SD | -2.8 score on a scale | Standard Error 0.6 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 46 | WSSQ-FE | -2.7 score on a scale | Standard Error 0.6 |
Comparison: WSSQ-SDp-value: 0.18Mixed Models Analysis
Comparison: WSSQ-FEp-value: 0.046Mixed Models Analysis
Comparison: WSSQ-Totalp-value: 0.05Mixed Models Analysis
Secondary
Change in Weight Self-stigma Scores at Week 72
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Time frame: Baseline to week 72
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-Total | -9.7 score on a scale | Standard Error 1.1 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-SD | -5.0 score on a scale | Standard Error 0.7 |
| Stigma + BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-FE | -4.7 score on a scale | Standard Error 0.7 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-Total | -6.7 score on a scale | Standard Error 1.1 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-SD | -3.8 score on a scale | Standard Error 0.6 |
| Standard BWL Intervention | Change in Weight Self-stigma Scores at Week 72 | WSSQ-FE | -2.9 score on a scale | Standard Error 0.7 |
Comparison: WSSQ-Totalp-value: 0.06Mixed Models Analysis
Comparison: WSSQ-SDp-value: 0.06Mixed Models Analysis
Comparison: WSSQ-FEp-value: 0.19Mixed Models Analysis
Secondary
Loss of 10% or Greater of Initial Body Weight at Week 20
The percentage of participants who lost 10% or greater of their initial body weight at week 20
Time frame: Baseline to week 20
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 20 | 11 Participants |
| Standard BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 20 | 5 Participants |
p-value: 0.2195% CI: [0.6, 11.4]Mixed Models Analysis
Secondary
Loss of 10% or Greater of Initial Body Weight at Week 46
The percentage of participants who lost 10% or greater of their initial body weight at week 46
Time frame: Baseline to week 46
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 46 | 15 Participants |
| Standard BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 46 | 9 Participants |
p-value: 0.2495% CI: [0.6, 8.1]Mixed Models Analysis
Secondary
Loss of 10% or Greater of Initial Body Weight at Week 72
The percentage of participants who lost 10% or greater of their initial body weight at week 72
Time frame: Baseline to week 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 72 | 14 Participants |
| Standard BWL Intervention | Loss of 10% or Greater of Initial Body Weight at Week 72 | 7 Participants |
p-value: 0.0695% CI: [1, 14.7]Mixed Models Analysis
Secondary
Loss of 5% or Greater of Initial Body Weight at Week 20
The percentage of participants who lost 5% or greater of their initial body weight at week 20
Time frame: Baseline to week 20
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 20 | 31 Participants |
| Standard BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 20 | 22 Participants |
p-value: 0.0795% CI: [0.9, 9.6]Mixed Models Analysis
Secondary
Loss of 5% or Greater of Initial Body Weight at Week 46
The percentage of participants who lost 5% or greater of their initial body weight at week 46
Time frame: Baseline to week 46
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 46 | 28 Participants |
| Standard BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 46 | 22 Participants |
p-value: 0.2495% CI: [0.6, 6.3]Mixed Models Analysis
Secondary
Loss of 5% or Greater of Initial Body Weight at Week 72
The percentage of participants who lost 5% or greater of their initial body weight at week 72
Time frame: Baseline to week 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 72 | 20 Participants |
| Standard BWL Intervention | Loss of 5% or Greater of Initial Body Weight at Week 72 | 21 Participants |
p-value: 0.8995% CI: [0.4, 3.4]Mixed Models Analysis
Secondary
Percent Weight Change at Week 20
Estimated mean percent weight change
Time frame: Baseline to week 20
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Percent Weight Change at Week 20 | -6.7 percent weight change | Standard Error 0.9 |
| Standard BWL Intervention | Percent Weight Change at Week 20 | -5.7 percent weight change | Standard Error 0.9 |
p-value: 0.42Mixed Models Analysis
Secondary
Percent Weight Change at Week 46
Estimated mean percent weight change
Time frame: Baseline to week 46
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stigma + BWL Intervention | Percent Weight Change at Week 46 | -8.2 percent weight change | Standard Error 0.9 |
| Standard BWL Intervention | Percent Weight Change at Week 46 | -5.9 percent weight change | Standard Error 0.9 |
p-value: 0.07Mixed Models Analysis
Secondary
Remission of Elevated Weight Bias Internalization at Week 20
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time frame: Baseline to week 20
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 20 | 25 Participants |
| Standard BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 20 | 26 Participants |
p-value: 0.9995% CI: [0.3, 3.1]Mixed Models Analysis
Secondary
Remission of Elevated Weight Bias Internalization at Week 46
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time frame: Baseline to week 46
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 46 | 24 Participants |
| Standard BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 46 | 25 Participants |
p-value: 0.9595% CI: [0.3, 3.3]Mixed Models Analysis
Secondary
Remission of Elevated Weight Bias Internalization at Week 72
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time frame: Baseline to week 72
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stigma + BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 72 | 28 Participants |
| Standard BWL Intervention | Remission of Elevated Weight Bias Internalization at Week 72 | 26 Participants |
p-value: 0.3895% CI: [0.5, 5.9]Mixed Models Analysis
Secondary
Treatment Acceptability at Week 20
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Time frame: Week 20
Population: Participants randomized to the stigma + BWL group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | Overall treatment acceptability | 6.4 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | BWL component acceptability | 6.1 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | BIAS vs recipe component acceptability | 6.1 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | BWL skill acquisition | 6.2 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | Stigma-related skill acquisition | 5.8 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 20 | Stigma-related skill use | 4.1 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | Stigma-related skill acquisition | 4.9 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | Overall treatment acceptability | 5.8 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | BWL skill acquisition | 5.6 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | BWL component acceptability | 5.9 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | Stigma-related skill use | 3.3 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Treatment Acceptability at Week 20 | BIAS vs recipe component acceptability | 4.6 score on a scale | Standard Error 0.2 |
Comparison: Overall treatment acceptabilityp-value: 0.04ANOVA
Comparison: BWL component acceptabilityp-value: 0.35ANOVA
Comparison: BIAS vs recipe component acceptabilityp-value: <0.001ANOVA
Comparison: BWL skill acquisitionp-value: 0.01ANOVA
Comparison: Stigma-related skill acquisitionp-value: <0.001ANOVA
Comparison: Stigma-related skill usep-value: <0.001ANOVA
Secondary
Treatment Acceptability at Week 72
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Time frame: Week 72
Population: Participants randomized to the stigma + BWL group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | Overall treatment acceptability | 6.1 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | BWL component acceptability | 6.0 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | BIAS vs recipe component acceptability | 5.9 score on a scale | Standard Error 0.3 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | BWL skill acquisition | 5.9 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | Stigma-related skill acquisition | 5.8 score on a scale | Standard Error 0.2 |
| Stigma + BWL Intervention | Treatment Acceptability at Week 72 | Stigma-related skill use | 3.8 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | Stigma-related skill acquisition | 5.0 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | Overall treatment acceptability | 5.8 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | BWL skill acquisition | 5.6 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | BWL component acceptability | 5.7 score on a scale | Standard Error 0.2 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | Stigma-related skill use | 3.3 score on a scale | Standard Error 0.1 |
| Standard BWL Intervention | Treatment Acceptability at Week 72 | BIAS vs recipe component acceptability | 4.1 score on a scale | Standard Error 0.3 |
Comparison: Overall treatment acceptabilityp-value: 0.24ANOVA
Comparison: BWL component acceptabilityp-value: 0.28ANOVA
Comparison: BIAS vs recipe component acceptabilityp-value: <0.001ANOVA
Comparison: BWL skill acquisitionp-value: 0.34ANOVA
Comparison: Stigma-related skill acquisitionp-value: 0.008ANOVA
Comparison: Stigma-related skill usep-value: 0.001ANOVA
Other Pre-specified
Change in Blood Glucose at Week 20
Concentration in blood, controlling for medication use
Time frame: Baseline to week 20
Other Pre-specified
Change in Blood Glucose at Week 72
Concentration in blood, controlling for medication use
Time frame: Baseline to week 72
Other Pre-specified
Change in Body Image Scores at Week 20
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Time frame: Baseline to week 20
Other Pre-specified
Change in Body Image Scores at Week 46
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Time frame: Baseline to week 46
Other Pre-specified
Change in Body Image Scores at Week 72
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Time frame: Baseline to week 72
Other Pre-specified
Change in C-reactive Protein at Week 20
Concentration in blood
Time frame: Baseline to week 20
Other Pre-specified
Change in C-reactive Protein at Week 72
Concentration in blood
Time frame: Baseline to week 72
Other Pre-specified
Change in Depression Symptoms at Week 20
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Time frame: Baseline to week 20
Other Pre-specified
Change in Depression Symptoms at Week 46
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Time frame: Baseline to week 46
Other Pre-specified
Change in Depression Symptoms at Week 72
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Time frame: Baseline to week 72
Other Pre-specified
Change in High-density Lipoprotein (HDL) Cholesterol at Week 20
Concentration in blood, controlling for medication use
Time frame: Baseline to week 20
Other Pre-specified
Change in High-density Lipoprotein (HDL) Cholesterol at Week 72
Concentration in blood, controlling for medication use
Time frame: Baseline to week 72
Other Pre-specified
Change in Minutes of Sedentary Time at Week 20
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 20
Other Pre-specified
Change in Minutes of Sedentary Time at Week 46
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 46
Other Pre-specified
Change in Minutes of Sedentary Time at Week 72
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 72
Other Pre-specified
Change in Perceived Stress at Week 20
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Time frame: Baseline to week 20
Other Pre-specified
Change in Perceived Stress at Week 46
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Time frame: Baseline to week 46
Other Pre-specified
Change in Perceived Stress at Week 72
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Time frame: Baseline to week 72
Other Pre-specified
Change in Presence and Frequency of Binge Eating at Week 20
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Time frame: Baseline to week 20
Other Pre-specified
Change in Presence and Frequency of Binge Eating at Week 46
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Time frame: Baseline to week 46
Other Pre-specified
Change in Presence and Frequency of Binge Eating at Week 72
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Time frame: Baseline to week 72
Other Pre-specified
Change in Self-monitoring Behaviors at Week 20
Food records and self-report recording of food intake and physical activity
Time frame: Baseline to week 20
Other Pre-specified
Change in Self-monitoring Behaviors at Week 46
Food records and self-report recording of food intake and physical activity
Time frame: Baseline to week 46
Other Pre-specified
Change in Self-monitoring Behaviors at Week 72
Food records and self-report recording of food intake and physical activity
Time frame: Baseline to week 72
Other Pre-specified
Change in Stereotype Endorsement Scores at Week 20
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Time frame: Baseline to week 20
Other Pre-specified
Change in Stereotype Endorsement Scores at Week 46
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Time frame: Baseline to week 46
Other Pre-specified
Change in Stereotype Endorsement Scores at Week 72
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Time frame: Baseline to week 72
Other Pre-specified
Change in Waist Circumference at Week 20
Time frame: Baseline to week 20
Other Pre-specified
Change in Waist Circumference at Week 72
Time frame: Baseline to week 72
Other Pre-specified
Change in Weight-related Quality of Life at Week 20
Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Time frame: Baseline to week 20
Other Pre-specified
Change in Weight-related Quality of Life at Week 46
Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Time frame: Baseline to week 46
Other Pre-specified
Change in Weight-related Quality of Life at Week 72
Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)
Time frame: Baseline to week 72