Obesity, Overweight, Weight Loss
Conditions
Keywords
Obesity, Weight loss, Overweight
Brief summary
The major goal of this project is to evaluate an innovative approach to obesity. This study will determine if behavioral treatment can be improved by 1) implementing a primary focus on PA following initial weight loss treatment, and 2) using a novel, acceptance-based approach to the promotion of PA.
Detailed description
Most adults who engage in lifestyle modification find it difficult to maintain a high level of PA over the long-term, and most also find that weight regain is inevitable. The current portfolio of available interventions does not adequately address these challenges. This project is designed to test the effectiveness of an intervention that is specifically designed to enhance the ability to maintain, in the long-term, a level of PA high enough to achieve long-term weight loss maintenance. In the study, 300 obese adults will be recruited from the community and provided with 6 months of group-based, standard behavioral treatment for induction of weight loss (Phase I). A 6-month Phase I was chosen so that all participants will have sufficient time to accomplish initial weight loss before Phase II begins, allowing Phase II to truly be a test of weight loss maintenance. In Phase II, participants will receive one of three interventions, to be delivered for an additional 12 months: 1) behavioral treatment, with the standard emphasis on maintaining changes in diet and PA (BT), 2) behavioral treatment, with a primary emphasis on using these skills to maintain PA (BT-PA), or 3) acceptance-based behavioral treatment, with a primary emphasis on using these skills to maintain PA (ABT-PA). Assessments will be conducted at baseline, 6 months, 18 months (end of treatment), 24 months (6-month follow-up), and 36 months (18-month follow-up).
Interventions
Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
BEHAVIORALBehavior Therapy for Weight Loss with Physical Activity Emphasis
Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
BEHAVIORALAcceptance-based Behavior Therapy for Weight Loss with PA emphasis
Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Sponsors
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have a BMI between 27 and 45 kg/m2 * Have the ability to engage in at least 15 minutes of moderate physical activity (e.g. brisk walking) * Successfully complete all steps in the enrollment process, including attendance at all pre-randomization clinic visits and providing physician clearance
Exclusion criteria
* Have a medical condition that prevents safe engagement in moderate-to-vigorous physical activity * Are lactating, pregnant, or planning to become pregnant in the next three years * Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain * Are participating in or plan to participate in another weight loss program in the next three years * Have a primary family member or member of their household participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months | Objectively measured in the research clinic at each time point on a scale |
| Change in Physical Activity | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months | Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months | Time taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness. |
| Waist Circumference | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months | Measured in the clinical horizontally at the umbilicus. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Moderator: Emotional Overeating | 0 months, 6 months | Emotional Overeating Questionnaire. The Emotional Overeating Questionnaire is a six-item self-report questionnaire designed to assess the frequency of emotional overeating (Masheb & Grilo, 2006). Participants rate their frequency of eating an unusually large amount over the prior 28 days in response to 6 emotions (anxiety, sadness, loneliness, tiredness, anger, and happiness) on a 7-point Likert scale: 0 = no days, 1 =1-5 days, 2 = 6-12 days, 3 = 13-15 days, 4 = 16-22 days, 5 = 23-27 days, and 6 = every day. Responses to the six items are averaged for a total score. Total scores range from 0-6 (units are scores on the scale). Higher total scores indicate more frequent emotional overeating (i.e., worse outcome). The Emotional Overeating Questionnaire has previously shown high internal consistency (alpha = 0.85) with test-retest reliability among individuals with Binge Eating Disorder (Masheb & Grilo, 2006). |
| Exploratory Moderator: Disinhibited Eating. | 0 months, 6 months | The 18-item Three Factor Eating Questionnaire (TFEQ) (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009) assessed disinhibited eating behavior. The questionnaire consists of statements about food and participants rate if they apply to them on a 4-point Likert scale (definitely true, mostly true, mostly false, definitely false). The questionnaire has a well-validated three-factor structure (Cronbach's α of 0.78-0.94), which includes a domain for disinhibited eating. This project used scoring from Niemeier, Phelan, Fava, & Wing, 2007, responses are coded 0 (mostly/definitely false) or 1 (mostly/definitely true). Total scores range from 0-18 (higher scores mean more problematic eating behaviors, i.e., worse outcome). The disinhibited eating subscale is the sum of 16 items (range 0-16), such as: Sometimes when I start eating, I just can't seem to stop. Higher scores indicate higher levels of disinhibited eating (i.e., worse outcome). Units are scores on the scale. |
| Exploratory Moderator: Hedonic Hunger | 0 months, 6 months | The Power of Food Scale is a 15-item self-report questionnaire that assesses the tendency to eat for pleasure (rather than physiological hunger) based on cues from the environment (Lowe et al., 2009). Items measure participants' appetite-related thoughts, feelings, and motivations for highly palatable foods with three subscales based on food proximity: (1) Food available in the environment but not physically present (sum of 6 items, range 6-30) (2) Food physically present but not yet tasted (sum of 4 items, range 4-20), and (3) Food tasted but not yet consumed (sum of 5 items, range 5-25). An example item is: If I see or smell a food I like, I get a powerful urge to have some. Participants rated each of these statements on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores are a sum of the 15 items (range 15-75) (units are scores on the scale). Higher total and subscale scores indicate greater hedonic hunger (i.e., worse outcome). |
| Exploratory Moderator: Appetitive Response to Exercise | 0 months, 6 months | Perceived Appetitive Response to Exercise. This was a single item measure, where participants were asked to select which one of these four options best described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This item was constructed by the research team, as no pre-existing measure of this construct was identified. The count and percent of participants within each category (by treatment condition) was calculated. This variable consists of four categorical responses, and thus does not have a minimum/maximum value. None of the response options are considered better or worse than the others. Each option describes separate potential experiences participants may have had in relation to eating/exercise over the past month. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Behavior Therapy for Weight Loss Eighteen months of standard, group-based behavioral treatment for weight loss and weight loss maintenance.
Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). | 110 |
| Behavior Therapy for Weight Loss With PA Emphasis Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of standard, group-based behavioral treatment for weight loss and weight loss maintenance with a larger emphasis on physical activity goals.
Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Behavior Therapy for Weight Loss with Physical Activity Emphasis: Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). | 105 |
| Acceptance-based Behavior Therapy With PA Emphasis Six months of standard, group-based behavioral treatment for weight loss and weight loss maintenance, followed by 12 months of group-based behavior therapy with acceptance-based strategies, and a larger emphasis on physical activity goals.
Gold Standard Behavior Therapy for Weight Loss: Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
Acceptance-based Behavior Therapy for Weight Loss with PA emphasis: Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). | 105 |
| Total | 320 |
Baseline characteristics
| Characteristic | Standard Behavior Therapy for Weight Loss | Behavior Therapy for Weight Loss With PA Emphasis | Acceptance-based Behavior Therapy With PA Emphasis | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 9 Participants | 7 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants | 96 Participants | 98 Participants | 289 Participants |
| Age, Continuous | 51.3 years STANDARD_DEVIATION 11.4 | 54.3 years STANDARD_DEVIATION 9.01 | 52.7 years STANDARD_DEVIATION 10.4 | 52.7 years STANDARD_DEVIATION 10.4 |
| BMI | 35.1 kg/m2 STANDARD_DEVIATION 4.3 | 34.5 kg/m2 STANDARD_DEVIATION 4.6 | 35.8 kg/m2 STANDARD_DEVIATION 5.3 | 35.1 kg/m2 STANDARD_DEVIATION 4.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 107 Participants | 99 Participants | 101 Participants | 307 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 26 Participants | 26 Participants | 80 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 73 Participants | 73 Participants | 224 Participants |
| Region of Enrollment United States | 110 participants | 105 participants | 105 participants | 320 participants |
| Sex: Female, Male Female | 90 Participants | 78 Participants | 82 Participants | 250 Participants |
| Sex: Female, Male Male | 20 Participants | 27 Participants | 23 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 0 / 110 | 0 / 105 | 0 / 105 |
| serious Total, serious adverse events | 0 / 110 | 0 / 105 | 0 / 105 |
Outcome results
Primary
Change in Body Weight
Objectively measured in the research clinic at each time point on a scale
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Change in Body Weight | 12 Months | 12.3 percent weight loss | Standard Deviation 8.9 |
| Standard Behavior Therapy for Weight Loss | Change in Body Weight | 6 Months | 10.5 percent weight loss | Standard Deviation 5.6 |
| Standard Behavior Therapy for Weight Loss | Change in Body Weight | 18 months | 10.2 percent weight loss | Standard Deviation 11.9 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Body Weight | 12 Months | 12.8 percent weight loss | Standard Deviation 8.2 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Body Weight | 6 Months | 10.2 percent weight loss | Standard Deviation 5 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Body Weight | 18 months | 12.4 percent weight loss | Standard Deviation 10.1 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Body Weight | 6 Months | 9.9 percent weight loss | Standard Deviation 4.7 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Body Weight | 18 months | 9.1 percent weight loss | Standard Deviation 10.3 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Body Weight | 12 Months | 11.6 percent weight loss | Standard Deviation 7.8 |
Comparison: Exploring group differences in 12 month weight losses.p-value: 0.68ANOVA
Comparison: Exploring group differences in 18 month weight losses.p-value: 0.11ANOVA
Primary
Change in Physical Activity
Objectively measured at each time point using wGT3X-BT accelerometers from Actigraph
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Change in Physical Activity | Baseline | 64.2 min per week of MVPA | Standard Deviation 91.9 |
| Standard Behavior Therapy for Weight Loss | Change in Physical Activity | 6 Months | 133.9 min per week of MVPA | Standard Deviation 124.5 |
| Standard Behavior Therapy for Weight Loss | Change in Physical Activity | 12 Months | 129.1 min per week of MVPA | Standard Deviation 117.5 |
| Standard Behavior Therapy for Weight Loss | Change in Physical Activity | 18 Months | 110.0 min per week of MVPA | Standard Deviation 134.6 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Physical Activity | 18 Months | 102.5 min per week of MVPA | Standard Deviation 124 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Physical Activity | Baseline | 64.2 min per week of MVPA | Standard Deviation 78.6 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Physical Activity | 12 Months | 144.6 min per week of MVPA | Standard Deviation 124.9 |
| Behavior Therapy for Weight Loss With PA Emphasis | Change in Physical Activity | 6 Months | 143.0 min per week of MVPA | Standard Deviation 121 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Physical Activity | 18 Months | 85.9 min per week of MVPA | Standard Deviation 101.7 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Physical Activity | 6 Months | 128.8 min per week of MVPA | Standard Deviation 115.7 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Physical Activity | 12 Months | 127.3 min per week of MVPA | Standard Deviation 126.9 |
| Acceptance-based Behavior Therapy With PA Emphasis | Change in Physical Activity | Baseline | 48.6 min per week of MVPA | Standard Deviation 73.6 |
Comparison: Exploring group differences in 12 month moderator to vigorous physical activity (MVPA).p-value: 0.41Compound Poisson general linear models
Comparison: Exploring group differences in 12 month MVPA.p-value: 0.46Compound Poisson general linear models
Comparison: Exploring group differences in 12 month MVPA.p-value: 0.82Compound Poisson general linear models
Comparison: Exploring group differences in 18 month MVPA.p-value: 0.42Compound Poisson general linear models
Comparison: Exploring group differences in 18 month MVPA.p-value: 0.28Compound Poisson general linear models
Comparison: Exploring group differences in 18 month MVPA.p-value: 0.82Compound Poisson general linear models
Secondary
Cardiorespiratory Fitness
Time taken to complete a half-mile walk on the treadmill. Shorter times indicate a greater level of cardiorespiratory fitness.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Cardiorespiratory Fitness | 18 months | 498.0 sec | Standard Deviation 80.9 |
| Standard Behavior Therapy for Weight Loss | Cardiorespiratory Fitness | 6 months | 503.9 sec | Standard Deviation 80.8 |
| Standard Behavior Therapy for Weight Loss | Cardiorespiratory Fitness | 12 months | 487.7 sec | Standard Deviation 74.7 |
| Standard Behavior Therapy for Weight Loss | Cardiorespiratory Fitness | Baseline | 537.1 sec | Standard Deviation 98.2 |
| Behavior Therapy for Weight Loss With PA Emphasis | Cardiorespiratory Fitness | 6 months | 528.2 sec | Standard Deviation 103.7 |
| Behavior Therapy for Weight Loss With PA Emphasis | Cardiorespiratory Fitness | 18 months | 518.4 sec | Standard Deviation 107.6 |
| Behavior Therapy for Weight Loss With PA Emphasis | Cardiorespiratory Fitness | Baseline | 576.6 sec | Standard Deviation 157.3 |
| Behavior Therapy for Weight Loss With PA Emphasis | Cardiorespiratory Fitness | 12 months | 512.2 sec | Standard Deviation 96.5 |
| Acceptance-based Behavior Therapy With PA Emphasis | Cardiorespiratory Fitness | 18 months | 517.0 sec | Standard Deviation 103.7 |
| Acceptance-based Behavior Therapy With PA Emphasis | Cardiorespiratory Fitness | 6 months | 514.1 sec | Standard Deviation 73.1 |
| Acceptance-based Behavior Therapy With PA Emphasis | Cardiorespiratory Fitness | 12 months | 500.5 sec | Standard Deviation 77.5 |
| Acceptance-based Behavior Therapy With PA Emphasis | Cardiorespiratory Fitness | Baseline | 562.2 sec | Standard Deviation 101.8 |
Comparison: Exploring group differences in 12 month cardiorespiratory fitness, measured by half-mile walk time.p-value: 0.06ANOVA
Comparison: Exploring group differences in 18 month cardiorespiratory fitness, measured by half-mile walk time.p-value: 0.3ANOVA
Secondary
Waist Circumference
Measured in the clinical horizontally at the umbilicus.
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Waist Circumference | Baseline | 42.6 cm | Standard Deviation 5.5 |
| Standard Behavior Therapy for Weight Loss | Waist Circumference | 6 Months | 39.0 cm | Standard Deviation 5.1 |
| Standard Behavior Therapy for Weight Loss | Waist Circumference | 12 Months | 38.6 cm | Standard Deviation 5.2 |
| Standard Behavior Therapy for Weight Loss | Waist Circumference | 18 Months | 39.2 cm | Standard Deviation 5.8 |
| Behavior Therapy for Weight Loss With PA Emphasis | Waist Circumference | 18 Months | 38.9 cm | Standard Deviation 5.3 |
| Behavior Therapy for Weight Loss With PA Emphasis | Waist Circumference | Baseline | 42.6 cm | Standard Deviation 4.7 |
| Behavior Therapy for Weight Loss With PA Emphasis | Waist Circumference | 12 Months | 38.8 cm | Standard Deviation 4.9 |
| Behavior Therapy for Weight Loss With PA Emphasis | Waist Circumference | 6 Months | 39.7 cm | Standard Deviation 4.8 |
| Acceptance-based Behavior Therapy With PA Emphasis | Waist Circumference | 18 Months | 38.5 cm | Standard Deviation 4.7 |
| Acceptance-based Behavior Therapy With PA Emphasis | Waist Circumference | 6 Months | 38.9 cm | Standard Deviation 4.3 |
| Acceptance-based Behavior Therapy With PA Emphasis | Waist Circumference | 12 Months | 38.2 cm | Standard Deviation 4.6 |
| Acceptance-based Behavior Therapy With PA Emphasis | Waist Circumference | Baseline | 41.8 cm | Standard Deviation 4.5 |
Comparison: Exploring group differences in 12 month waist circumference.p-value: 0.59ANOVA
Comparison: Exploring group differences in 18 month waist circumference.p-value: 0.57ANOVA
Other Pre-specified
Exploratory Moderator: Appetitive Response to Exercise
Perceived Appetitive Response to Exercise. This was a single item measure, where participants were asked to select which one of these four options best described their experience in the past month: There is no relationship between my level of exercise and my appetite; Exercise helps me control my appetite - I am less hungry when I am exercising regularly; Exercise increases my appetite - I am more hungry when I am exercising regularly; Not applicable because not exercising. This item was constructed by the research team, as no pre-existing measure of this construct was identified. The count and percent of participants within each category (by treatment condition) was calculated. This variable consists of four categorical responses, and thus does not have a minimum/maximum value. None of the response options are considered better or worse than the others. Each option describes separate potential experiences participants may have had in relation to eating/exercise over the past month.
Time frame: 0 months, 6 months
Population: Number of participants analyzed at 6 months may differ from that at baseline based on differential completion of measures by each participant at each timepoint.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Not applicable (I have not exercised). | 16 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | Baseline | There is no relationship between my level of exercise and my appetite. | 34 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 26 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 17 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Not applicable (I have not exercised). | 1 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | There is no relationship between my level of exercise and my appetite. | 35 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 34 Participants |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 22 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 25 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 37 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 12 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Not applicable (I have not exercised). | 3 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | There is no relationship between my level of exercise and my appetite. | 30 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Not applicable (I have not exercised). | 15 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | There is no relationship between my level of exercise and my appetite. | 32 Participants |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 19 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 17 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | There is no relationship between my level of exercise and my appetite. | 34 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Not applicable (I have not exercised). | 19 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | Baseline | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 14 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise helps me control my appetite - I am less hungry when I am exercising regularly. | 31 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | There is no relationship between my level of exercise and my appetite. | 32 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Not applicable (I have not exercised). | 4 Participants |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Appetitive Response to Exercise | 6 Months | Exercise increases my appetite - I am more hungry when I am exercising regularly. | 17 Participants |
Comparison: The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.926Regression, Linear
Comparison: The null hypothesis was that baseline Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.82Regression, Poison
Comparison: The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.127Regression, Linear
Comparison: The null hypothesis was that 6-month Appetitive Response to Exercise would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.814Regression, Poison
Other Pre-specified
Exploratory Moderator: Disinhibited Eating.
The 18-item Three Factor Eating Questionnaire (TFEQ) (Cappelleri, Bushmakin, Gerber, Leidy, Sexton, Lowe, et al., 2009) assessed disinhibited eating behavior. The questionnaire consists of statements about food and participants rate if they apply to them on a 4-point Likert scale (definitely true, mostly true, mostly false, definitely false). The questionnaire has a well-validated three-factor structure (Cronbach's α of 0.78-0.94), which includes a domain for disinhibited eating. This project used scoring from Niemeier, Phelan, Fava, & Wing, 2007, responses are coded 0 (mostly/definitely false) or 1 (mostly/definitely true). Total scores range from 0-18 (higher scores mean more problematic eating behaviors, i.e., worse outcome). The disinhibited eating subscale is the sum of 16 items (range 0-16), such as: Sometimes when I start eating, I just can't seem to stop. Higher scores indicate higher levels of disinhibited eating (i.e., worse outcome). Units are scores on the scale.
Time frame: 0 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Disinhibited Eating. | Baseline | 8.50 units on a scale | Standard Deviation 3.08 |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Disinhibited Eating. | 6 months | 7.55 units on a scale | Standard Deviation 3.03 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Disinhibited Eating. | Baseline | 8.89 units on a scale | Standard Deviation 3.38 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Disinhibited Eating. | 6 months | 7.77 units on a scale | Standard Deviation 3.27 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Disinhibited Eating. | 6 months | 7.54 units on a scale | Standard Deviation 3.6 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Disinhibited Eating. | Baseline | 9.40 units on a scale | Standard Deviation 3.61 |
Comparison: The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.487Regression, Linear
Comparison: The null hypothesis was that baseline Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.262Regression, Poison
Comparison: The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.851Regression, Linear
Comparison: The null hypothesis was that 6-month Disinhibited Eating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.978Regression, Poison
Other Pre-specified
Exploratory Moderator: Emotional Overeating
Emotional Overeating Questionnaire. The Emotional Overeating Questionnaire is a six-item self-report questionnaire designed to assess the frequency of emotional overeating (Masheb & Grilo, 2006). Participants rate their frequency of eating an unusually large amount over the prior 28 days in response to 6 emotions (anxiety, sadness, loneliness, tiredness, anger, and happiness) on a 7-point Likert scale: 0 = no days, 1 =1-5 days, 2 = 6-12 days, 3 = 13-15 days, 4 = 16-22 days, 5 = 23-27 days, and 6 = every day. Responses to the six items are averaged for a total score. Total scores range from 0-6 (units are scores on the scale). Higher total scores indicate more frequent emotional overeating (i.e., worse outcome). The Emotional Overeating Questionnaire has previously shown high internal consistency (alpha = 0.85) with test-retest reliability among individuals with Binge Eating Disorder (Masheb & Grilo, 2006).
Time frame: 0 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Emotional Overeating | Baseline | 0.62 units on a scale | Standard Deviation 0.83 |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Emotional Overeating | 6 months | 0.50 units on a scale | Standard Deviation 0.54 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Emotional Overeating | Baseline | 0.58 units on a scale | Standard Deviation 0.65 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Emotional Overeating | 6 months | 0.53 units on a scale | Standard Deviation 0.61 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Emotional Overeating | Baseline | 0.81 units on a scale | Standard Deviation 0.86 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Emotional Overeating | 6 months | 0.58 units on a scale | Standard Deviation 0.6 |
Comparison: The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.978Regression, Linear
Comparison: The null hypothesis was that baseline Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.998Regression, Poison
Comparison: The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.878Regression, Linear
Comparison: The null hypothesis was that 6-month Emotional Overeating would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.602Regression, Poison
Other Pre-specified
Exploratory Moderator: Hedonic Hunger
The Power of Food Scale is a 15-item self-report questionnaire that assesses the tendency to eat for pleasure (rather than physiological hunger) based on cues from the environment (Lowe et al., 2009). Items measure participants' appetite-related thoughts, feelings, and motivations for highly palatable foods with three subscales based on food proximity: (1) Food available in the environment but not physically present (sum of 6 items, range 6-30) (2) Food physically present but not yet tasted (sum of 4 items, range 4-20), and (3) Food tasted but not yet consumed (sum of 5 items, range 5-25). An example item is: If I see or smell a food I like, I get a powerful urge to have some. Participants rated each of these statements on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores are a sum of the 15 items (range 15-75) (units are scores on the scale). Higher total and subscale scores indicate greater hedonic hunger (i.e., worse outcome).
Time frame: 0 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Hedonic Hunger | Baseline | 40.00 units on a scale | Standard Deviation 13.18 |
| Standard Behavior Therapy for Weight Loss | Exploratory Moderator: Hedonic Hunger | 6 months | 39.01 units on a scale | Standard Deviation 13.58 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Hedonic Hunger | Baseline | 38.81 units on a scale | Standard Deviation 13.04 |
| Behavior Therapy for Weight Loss With PA Emphasis | Exploratory Moderator: Hedonic Hunger | 6 months | 37.14 units on a scale | Standard Deviation 13.11 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Hedonic Hunger | Baseline | 42.65 units on a scale | Standard Deviation 13.83 |
| Acceptance-based Behavior Therapy With PA Emphasis | Exploratory Moderator: Hedonic Hunger | 6 months | 39.04 units on a scale | Standard Deviation 12.92 |
Comparison: The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.796Regression, Linear
Comparison: The null hypothesis was that baseline Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month MVPA. As a note, multiple imputation for missing MVPA data was not conducted for exploratory moderation analyses.p-value: 0.481Regression, Poison
Comparison: The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.872Regression, Linear
Comparison: The null hypothesis was that 6-month Hedonic Hunger would not significantly moderate the relationship between the three treatment conditions and 36-month weight loss. As a note, multiple imputation for missing weight loss data was not conducted for exploratory moderation analyses.p-value: 0.802Regression, Poison