An interventional study of Stigma-Reduction Intervention and Behavioral Weight Loss (BWL) in Obesity, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-02.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
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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:
Eligible female patients will be:
Participants must:
Exclusion Criteria:
Applicants will be excluded if they have:
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.
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.
Behavioral: Stigma-Reduction Intervention · Behavioral: Behavioral Weight Loss (BWL)
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.
Behavioral: Behavioral Weight Loss (BWL)
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.
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.
Percent Weight Change at Week 72
Estimated mean percent change in weight from baseline to week 72
Time frame: Baseline to week 72
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
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
Percent Weight Change at Week 46
Estimated mean percent weight change
Time frame: Baseline to week 46
Percent Weight Change at Week 20
Estimated mean percent weight change
Time frame: Baseline to week 20
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change in Triglycerides at Week 72
Estimated mean change in triglyceride concentration in blood
Time frame: Baseline to week 72
Change in Triglycerides at Week 20
Estimated mean change in triglyceride concentration in blood
Time frame: Baseline to week 20
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
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
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
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
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
"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
"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
"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
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
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
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
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
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
Change in Minutes of Sedentary Time at Week 72
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 72
Change in Minutes of Sedentary Time at Week 46
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 46
Change in Minutes of Sedentary Time at Week 20
Single item from Global Physical Activity Questionnaire (minutes)
Time frame: Baseline to week 20
Change in High-density Lipoprotein (HDL) Cholesterol at Week 72
Concentration in blood, controlling for medication use
Time frame: Baseline to week 72
Change in High-density Lipoprotein (HDL) Cholesterol at Week 20
Concentration in blood, controlling for medication use
Time frame: Baseline to week 20
Change in Waist Circumference at Week 72
Time frame: Baseline to week 72
Change in Waist Circumference at Week 20
Time frame: Baseline to week 20
Change in Blood Glucose at Week 72
Concentration in blood, controlling for medication use
Time frame: Baseline to week 72
Change in Blood Glucose at Week 20
Concentration in blood, controlling for medication use
Time frame: Baseline to week 20
Change in C-reactive Protein at Week 72
Concentration in blood
Time frame: Baseline to week 72
Change in C-reactive Protein at Week 20
Concentration in blood
Time frame: Baseline to week 20
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Started | 52 | 53 |
| Week 20 | 44 | 46 |
| Week 46 | 44 | 46 |
| Week 72 | 42 | 47 |
| Completed | 42 | 47 |
| Not completed | 10 | 6 |
| Withdrew: Lost to follow-up | 8 | 4 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: No longer available for study visits | 0 | 1 |
| Withdrew: Censoring event | 1 | 0 |
Estimated mean percent change in weight from baseline to week 72
| percent weight change | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Percent Weight Change at Week 72 | -7.16 ± 0.95 | -5.19 ± 0.92 |
The percentage of participants who lost 5% or greater of their initial body weight at week 72
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 5% or Greater of Initial Body Weight at Week 72 | 20 | 21 |
The percentage of participants who lost 10% or greater of their initial body weight at week 72
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 10% or Greater of Initial Body Weight at Week 72 | 14 | 7 |
Estimated mean percent weight change
| percent weight change | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Percent Weight Change at Week 46 | -8.2 ± 0.9 | -5.9 ± 0.9 |
Estimated mean percent weight change
| percent weight change | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Percent Weight Change at Week 20 | -6.7 ± 0.9 | -5.7 ± 0.9 |
The percentage of participants who lost 5% or greater of their initial body weight at week 46
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 5% or Greater of Initial Body Weight at Week 46 | 28 | 22 |
The percentage of participants who lost 10% or greater of their initial body weight at week 46
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 10% or Greater of Initial Body Weight at Week 46 | 15 | 9 |
The percentage of participants who lost 5% or greater of their initial body weight at week 20
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 5% or Greater of Initial Body Weight at Week 20 | 31 | 22 |
The percentage of participants who lost 10% or greater of their initial body weight at week 20
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Loss of 10% or Greater of Initial Body Weight at Week 20 | 11 | 5 |
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
| Minutes per day | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| MVPA per day with 10 minute bouts | 9.6 ± 4.1 | 7.2 ± 4.1 |
| MVPA per day with 20 minute bouts | 9.4 ± 3.2 | 8.4 ± 3.1 |
| Moderate activity per day | 3.2 ± 6.8 | -10.2 ± 6.7 |
| Light activity per day | -35.6 ± 15.1 | -51.5 ± 14.3 |
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
| Minutes per day | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| MVPA per day with 10 minute bouts | 9.5 ± 4.3 | 5.4 ± 4.4 |
| MVPA per day with 20 minute bouts | 9.9 ± 3.4 | 10.5 ± 3.2 |
| Moderate activity per day | 0.6 ± 7.2 | -17.9 ± 7.2 |
| Light activity per day | -37.1 ± 15.9 | -67.0 ± 16.0 |
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
| Minutes per day | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| MVPA per day with 10 minute bouts | 11.4 ± 4.0 | 8.8 ± 4.1 |
| MVPA per day with 20 minute bouts | 10.5 ± 2.6 | 9.9 ± 2.7 |
| Moderate activity per day | 10.6 ± 6.7 | 4.7 ± 6.7 |
| Light activity per day | -19.0 ± 14.2 | 3.8 ± 13.2 |
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
| Kcal | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Energy Expenditure at Week 72 | 314.8 ± 105.9 | 307.5 ± 108.0 |
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
| Kcal | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Energy Expenditure at Week 46 | 148.7 ± 90.1 | 260.4 ± 103.5 |
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
| Kcal | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Energy Expenditure at Week 20 | 452.5 ± 111.9 | 289.3 ± 105.6 |
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Exercise Self-efficacy at Week 72 | -9.4 ± 3.3 | -15.0 ± 3.2 |
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Exercise Self-efficacy at Week 46 | -10.6 ± 3.2 | -15.9 ± 3.2 |
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Exercise Self-efficacy at Week 20 | 1.1 ± 3.2 | -2.0 ± 3.1 |
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Eating Self-efficacy at Week 72 | 6.5 ± 2.5 | 1.7 ± 2.4 |
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Eating Self-efficacy at Week 46 | 5.8 ± 2.4 | -1.0 ± 2.4 |
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Eating Self-efficacy at Week 20 | 12.3 ± 2.4 | 8.6 ± 2.3 |
Estimated mean change in triglyceride concentration in blood
| mg/dL | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Triglycerides at Week 72 | -9.9 ± 6.4 | -13.7 ± 6.8 |
Estimated mean change in triglyceride concentration in blood
| mg/dL | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Triglycerides at Week 20 | -10.9 ± 6.3 | -7.7 ± 6.5 |
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
| mmHg | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Systolic Blood Pressure | -5.0 ± 1.7 | -5.6 ± 1.8 |
| Diastolic Blood Pressure | -1.9 ± 1.1 | -2.0 ± 1.1 |
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
| mmHG | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Systolic Blood Pressure | -9.7 ± 1.7 | -5.4 ± 1.6 |
| Diastolic Blood Pressure | -3.5 ± 1.1 | -3.6 ± 1.1 |
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization).
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Weight Bias Internalization Scale Score at Week 72 | -1.7 ± 0.2 | -1.5 ± 0.1 |
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Weight Bias Internalization Scale Score at Week 46 | -1.5 ± 0.1 | -1.4 ± 0.1 |
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Change in Weight Bias Internalization Scale Score at Week 20 | -1.4 ± 0.1 | -1.2 ± 0.1 |
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)
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| "Remission" of Elevated Weight Bias Internalization at Week 72 | 28 | 26 |
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)
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| "Remission" of Elevated Weight Bias Internalization at Week 46 | 24 | 25 |
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)
| Participants | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| "Remission" of Elevated Weight Bias Internalization at Week 20 | 25 | 26 |
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.
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| WSSQ-Total | -9.7 ± 1.1 | -6.7 ± 1.1 |
| WSSQ-SD | -5.0 ± 0.7 | -3.8 ± 0.6 |
| WSSQ-FE | -4.7 ± 0.7 | -2.9 ± 0.7 |
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.
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| WSSQ-Total | -8.5 ± 1.1 | -5.5 ± 1.1 |
| WSSQ-SD | -4.0 ± 0.7 | -2.8 ± 0.6 |
| WSSQ-FE | -4.5 ± 0.6 | -2.7 ± 0.6 |
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.
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| WSSQ-Total | -8.2 ± 1.1 | -5.5 ± 1.1 |
| WSSQ-SD | -4.6 ± 0.7 | -3.2 ± 0.6 |
| WSSQ-FE | -3.6 ± 0.6 | -2.3 ± 0.6 |
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.
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Overall treatment acceptability | 6.4 ± 0.2 | 5.8 ± 0.2 |
| BWL component acceptability | 6.1 ± 0.2 | 5.9 ± 0.2 |
| BIAS vs recipe component acceptability | 6.1 ± 0.2 | 4.6 ± 0.2 |
| BWL skill acquisition | 6.2 ± 0.2 | 5.6 ± 0.2 |
| Stigma-related skill acquisition | 5.8 ± 0.2 | 4.9 ± 0.2 |
| Stigma-related skill use | 4.1 ± 0.1 | 3.3 ± 0.1 |
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.
| score on a scale | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Overall treatment acceptability | 6.1 ± 0.2 | 5.8 ± 0.2 |
| BWL component acceptability | 6.0 ± 0.2 | 5.7 ± 0.2 |
| BIAS vs recipe component acceptability | 5.9 ± 0.3 | 4.1 ± 0.3 |
| BWL skill acquisition | 5.9 ± 0.2 | 5.6 ± 0.2 |
| Stigma-related skill acquisition | 5.8 ± 0.2 | 5.0 ± 0.2 |
| Stigma-related skill use | 3.8 ± 0.1 | 3.3 ± 0.1 |
Single item from Global Physical Activity Questionnaire (minutes)
Results for this outcome have not been posted.
Single item from Global Physical Activity Questionnaire (minutes)
Results for this outcome have not been posted.
Single item from Global Physical Activity Questionnaire (minutes)
Results for this outcome have not been posted.
Concentration in blood, controlling for medication use
Results for this outcome have not been posted.
Concentration in blood, controlling for medication use
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Concentration in blood, controlling for medication use
Results for this outcome have not been posted.
Concentration in blood, controlling for medication use
Results for this outcome have not been posted.
Concentration in blood
Results for this outcome have not been posted.
Concentration in blood
Results for this outcome have not been posted.
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Results for this outcome have not been posted.
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Results for this outcome have not been posted.
Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Results for this outcome have not been posted.
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Results for this outcome have not been posted.
Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)
Results for this outcome have not been posted.
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Results for this outcome have not been posted.
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Results for this outcome have not been posted.
Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)
Results for this outcome have not been posted.
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Results for this outcome have not been posted.
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Results for this outcome have not been posted.
Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)
Results for this outcome have not been posted.
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Results for this outcome have not been posted.
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Results for this outcome have not been posted.
Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)
Results for this outcome have not been posted.
Food records and self-report recording of food intake and physical activity
Results for this outcome have not been posted.
Food records and self-report recording of food intake and physical activity
Results for this outcome have not been posted.
Food records and self-report recording of food intake and physical activity
Results for this outcome have not been posted.
Collected over Baseline through week 72. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stigma + BWL Intervention | 0/52 (0%) | 0/52 (0%) | 14/52 (26.9%) |
| Standard BWL Intervention | 0/53 (0%) | 0/53 (0%) | 17/53 (32.1%) |
| Event | Stigma + BWL Intervention | Standard BWL Intervention |
|---|---|---|
| Viral gastroenteritisInfections and infestations | 3/52 | 7/53 |
| Back painMusculoskeletal and connective tissue disorders | 3/52 | 5/53 |
| Contact dermatitisProduct Issues | 4/52 | 2/53 |
| MigraineNervous system disorders | 4/52 | 1/53 |
| Knee painMusculoskeletal and connective tissue disorders | 3/52 | 4/53 |
| COVID-19Infections and infestations | 2/52 | 3/53 |
| Age, Continuous(years) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Mean | 48.96 ± 12.86 | 49.15 ± 12.05 | 49.06 ± 12.40 |
| Sex: Female, Male(Participants) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Female | 49 | 46 | 95 |
| Male | 3 | 7 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 52 | 50 | 102 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 12 | 14 | 26 |
| White | 37 | 37 | 74 |
| More than one race | 3 | 0 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Mean | 104.39 ± 18.21 | 104.48 ± 21.04 | 104.44 ± 19.59 |
| Height(cm) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Mean | 165.04 ± 7.13 | 166.35 ± 7.87 | 165.70 ± 7.51 |
| Body mass index (BMI)(kg/m^2) | Stigma + BWL Intervention | Standard BWL Intervention | Total |
|---|---|---|---|
| Mean | 38.23 ± 5.59 | 37.48 ± 5.16 | 37.85 ± 5.36 |
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