A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss
Phase: NA
Conditions: Obesity
Sponsor: University of Pennsylvania

  
 
 
IRB Approval: May 10, 2021 
Title: A Randomized Controlled Trial of Behavioral Weight 
Loss and Stigma-Reduction for Long-Term Weight Loss 
 
NCT03704064 
 
 

 
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Title: A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction 
for Long-Term Weight Loss 
 
 
Principal Investigator:  
Rebecca L. Pearl, Ph.D. 
 
Co- Investigators: 
  
Thomas A. Wadden, Ph.D.  
Robert I. Berkowitz, M.D.   
                          
Study Sites:   
 
University of Florida 
                      
 
University of Pennsylvania 
 
 
1. STUDY OBJECTIVE 
 
To evaluate, in a 72-week randomized controlled trial, the efficacy of a psychological 
intervention to reduce weight bias internalization (WBI) on enhancing long-term weight loss. 
 
2. BACKGROUND 
 
2.1 The Problem of Obesity 
 
Obesity, defined by a BMI ≥ 30 kg/m² (or ≥ 27 kg/m² with a weight-related comorbidity), is the 
most common nutritional disease in the United States, affecting about 36% of adults age 20 years 
and over. An additional 33% of American adults are overweight, as judged by a BMI of 25.0-
29.9 kg/m². Obesity is associated with a number of co-morbidities including type 2 diabetes 
(70% of people with type 2 diabetes have obesity) and cardiovascular disease. Losing as little as 
5% of initial weight improves co-morbid conditions including insulin resistance, dyslipidemia, 
and hypertension.  
 
A program of diet, physical activity and behavioral therapy is the first line treatment for obesity. 
This approach produces significant weight loss (≥5%) but is often followed by weight gain. 
Patients regain about 35% of their initial weight loss in the first year and 50% or more have 
returned to their baseline weight by 5 yr. It is therefore, highly desirable to identify effective 
interventions, which would improve long-term maintenance of prior weight loss. 
 
2.2 Benefits of Weight loss 
 
A 5–10% reduction in body weight in obese individuals improves several risk factors for 
cardiovascular disease (CVD) including blood pressure, triglyceride levels, low-density-
lipoprotein cholesterol, blood glucose, and sleep apnea.1-3 The Diabetes Prevention Program 
(DPP) revealed that a 7% reduction in initial weight, combined with 150 minutes of activity, 
reduced the risk of developing type 2 diabetes by 58%, compared with placebo, in at-risk 
overweight/obese individuals at an average of 2.8 years follow-up.4  Losses >10% are associated 
with greater improvements in CVD risk factors5 and are more consistent with obese individuals’ 
desired weight loss goals. 6 

 
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2.3 Current Status of Behavioral Weight Loss Treatment for Obesity  
 
Behavioral weight loss (BWL) treatment is the cornerstone of treatment for most obese 
individuals, as recommended by the NHLBI’s Clinical Guidelines on the Identification, 
Evaluation, and Treatment of Overweight and Obesity in Adults.7 In trials conducted in academic 
medical centers, persons treated by a 1200-1500 kcal/d diet, combined with regular exercise and a 
comprehensive program of group or individual BWL, lose approximately 7-10% of initial weight 
in 20-26 weeks.4,8,9  
 
2.4. Role of Physical Activity in Facilitating Long-Term Weight Loss 
 
Physical activity is the most reliable predictor of long-term weight loss.9,10 Studies consistently 
show that participants are more likely to achieve and maintain significant long-term weight loss 
(e.g., ≥10%) when they engage in high levels (e.g., ≥ 200-250 minutes per week) of physical 
activity.10-15 For example, in secondary analyses of a randomized controlled trial evaluating the 
effects of different doses of exercise on weight loss, Jakicic et al showed that participants who 
reported exercising ≥ 200 min/wk had significantly greater weight loss at month 12 (by 6.3 kg) 
than participants who exercised <150 min/wk.13 Another study found that participants who 
maintained a 10% weight loss 24 months after treatment reported engaging in an average of 275 
min/wk of physical activity.12 These observational data are supported by findings from some but 
not all randomized trials.12,16 
 
One pathway to increasing physical activity is by boosting exercise self-efficacy. Self-efficacy – 
which refers to individuals’ confidence in their ability to engage in goal-directed behavior – 
robustly predicts initiation and maintenance of health behavior change,17 including weight-loss 
behaviors such as adherence to diet and physical activity recommendations.18-20 Greater weight-
related self-efficacy is associated with greater short- and long-term weight loss20-24 and, in 
comparison to dietary self-efficacy, self-efficacy to exercise is a stronger predictor of weight 
loss.25 Self-efficacy may naturally decrease during long-term weight-loss maintenance.23 A 
recent study found that an intervention designed to increase self-efficacy (combined with 
standard BWL) resulted in significantly less weight regain from months 12 to 18 of follow-up 
than BWL alone.26  
 
2.5 Weight Stigma as a Barrier to Weight Loss 
 
2.5.1. Weight stigma is pervasive.  
 
The term weight stigma refers to societal scorn and devaluation of individuals with overweight 
and obesity.27 This includes discrimination (e.g., being denied employment), bullying/teasing, 
social exclusion and avoidance (e.g., rejection from peers), and other forms of unfair treatment 
due to excess weight. Common stereotypes and prejudicial (or weight-biased) beliefs include 
perceptions that persons with obesity are lazy, incompetent, weak, and lacking willpower.11 
These beliefs lead individuals with obesity to be mistreated across multiple settings in their daily 
lives, including: disparagement in educational settings from students and educators; 

 
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discrimination in hiring, firing, and promotions; social avoidance (e.g., on public transportation); 
criticism from family members, spouses, and friends; and negative representation in media.28-32   
 
The high rates of obesity and overweight in the US population are accompanied by high rates of 
weight-based stigmatization. Estimates indicate that rates of weight-based discrimination have 
increased by 66% from 1995 to 2006 and, among women, are comparable to rates of 
discrimination based on race and age.33,34 Due to the pervasiveness of weight bias in daily life, 
some individuals may internalize stigmatizing attitudes; this occurrence is referred to as weight 
bias internalization (WBI), or self-directed stigma.35 Internalizing stigma involves: 1) awareness 
of and agreement with stereotypes; 2) applying of those stereotypes to oneself; and 3) devaluing 
oneself due to the stigmatized trait (i.e., weight).36 For example, someone who is unable to 
successfully maintain weight loss may attribute weight regain to laziness and weakness, and have 
lower self-esteem due to assigning these stereotypical characteristics to oneself.   
 
2.5.2. Weight stigma impedes weight control.  
 
Individuals with obesity who experience and internalize weight stigma may benefit from weight 
loss to improve their health, yet may face stigma-specific barriers to weight loss. In two 
longitudinal studies, individuals who reported experiencing weight discrimination at baseline 
were three times more likely to remain obese37 and gained 1.7 more kg than individuals who did 
not report weight discrimination.38 Recent studies have also illustrated that patients who have 
experienced and/or internalized weight stigma, in comparison to those who have not, have poorer 
long-term weight loss outcomes with both behavioral and surgical weight loss interventions.39-42 
For example, in a study of 49 adults with BMI ≥ 27 kg/m2 who received behavioral weight loss 
(BWL) treatment, higher frequency of receiving weight-stigmatizing comments from others was 
associated with less weight loss and less physical activity.39 In another study, participants who 
consciously or unconsciously endorsed negative weight stereotypes (one aspect of WBI) also lost 
less weight and reported less physical activity.46 Proposed pathways for these effects include a 
combination of physiological stress responses that increase inflammation and appetite, and 
maladaptive behavioral coping responses such as increased caloric intake and avoidance of 
physical activity.34 
 
Acute and long-term studies have shown that weight stigma (particularly WBI) is associated with 
reduced self-efficacy for dietary control,43 with increased caloric consumption (particularly of 
unhealthy foods),43-45 and with worse dietary adherence following bariatric surgery.46 In addition, 
individuals who experience weight stigma feel more self-conscious in fitness settings and are 
more prone to anticipating future stigmatization in these settings, thus increasing avoidance of 
physical activity.47-49 In prior work, my colleagues and I have also shown associations between 
WBI and reduced self-efficacy to engage in physical activity, along with reduced exercise 
motivation and engagement.50 In other words, if individuals with obesity believe that they are 
lazy and lack willpower (internalized stereotypes), they lose confidence in their ability to follow 
through on their physical activity goals and are, thus, less likely to engage in their planned 
physical activity.50,51  
 
2.5.3. Addressing weight stigma in weight loss interventions 
 

 
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Weight stigma-specific barriers are not addressed in current weight loss programs. As stated 
above, cognitive-behavioral treatments for weight loss produce clinically meaningful losses in 
the short-term,52 which reduce cardiometabolic risk.53-55 However, these losses are not 
maintained, on average, in the long-term,52,56 highlighting the need to develop novel treatments 
to sustain weight loss. Adherence to high levels of physical activity predicts long-term weight 
loss.57 Given the evidence reviewed that individuals who have experienced and/or internalized 
weight stigma have reduced self-efficacy for and engagement in physical activity, an 
intervention targeting weight stigma may improve long-term weight loss.  
 
An intervention that combines traditional BWL with a program to reduce WBI could produce 
clinically meaningful short- and long-term weight losses, as well as reductions in self-
stigmatization. The intervention to reduce WBI is expected to increase long-term exercise self-
efficacy and adherence, thus, facilitating long-term weight loss. An intervention that incorporates 
elements from both approaches could provide patients with multifaceted health benefits. 
 
3. SPECIFIC AIMS 
 
Aim 1. To test, in a randomized controlled trial, the effects of a novel 29-session cognitive-
behavioral weight stigma intervention, combined with BWL (in comparison to standard BWL 
alone), in producing long-term weight loss (at week 72) in a total of 104 individuals with obesity 
who have experienced weight stigma.  
 
H1: Patients who receive the stigma + BWL intervention will achieve significantly greater 
weight loss at week 72 than patients assigned to standard BWL (9% and 5% of initial weight, 
respectively).  
 
Aim 2. To assess whether the stigma + BWL intervention significantly increases physical 
activity and self-efficacy (as compared with BWL alone). 
 
H2: Patients who receive the stigma + BWL intervention will achieve significantly greater levels 
of physical activity and exercise self-efficacy at weeks 20, 46, and 72 than patients assigned to 
standard BWL.  
 
Secondary Aims 
3. To compare changes in cardiometabolic risk factors (e.g., metabolic syndrome) in patients 
assigned to the stigma + BWL intervention versus BWL alone.  
 
H3: Patients who receive the stigma + BWL intervention will achieve significantly greater 
reductions in cardiometabolic risk at week 72 than patients assigned to standard BWL.  
 
4. To evaluate changes in psychological distress (e.g., WBI) in the stigma + BWL intervention 
compared to BWL alone.  
 
H4: Participants who receive the stigma + BWL intervention will have greater reductions in 
WBI and psychological distress at weeks 20, 46, and 72 than participants receiving BWL alone. 
 

 
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5. To compare short-term weight change in patients assigned to the stigma + BWL intervention 
versus BWL alone.  
 
H5: Participants who receive the stigma + BWL intervention will achieve significantly greater 
weight loss than patients assigned to standard BWL at weeks 20 and 46.  
 
4. STUDY DESIGN 
 
4.1 General Design 
 
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 18years 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, beginning at week 5, 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. 
 
Other Therapy: 
 
Participants will be expected to use medications (prescribed by their primary care providers) to 
control traditional cardiometabolic risk factors (e.g., hypertension, hypercholesterolemia, etc) 
and other co-morbid conditions. Subjects will be asked at the study’s outset to keep medication 
dose constant throughout the study, whenever possible. Participants will be expected to have 
been on their medication regimen (including the dose) for 3 months prior to entering the dietary 
group lifestyle modification program. 
 
5. SUBJECT SELECTION 
 
5.1 Subject Recruitment 
 

 
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Participants will be recruited from advertisements in local media outlets (newspapers, radio, 
television, social media), as well as flyers and public transportation in the surrounding area. Online 
and print media outlets at the University (such as newsletters) will also be used to advertise the study.  
We also will advertise the study to health care providers who work in Penn’s Clinical Care Associate 
practices, with whom we have collaborated previously.58  
 
5.2 Inclusion/Exclusion Criteria 
 
 Key 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. 
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.19 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 
 
Key Exclusion Criteria: 

 
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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). 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. 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. 
 
6. STUDY PROCEDURES 
 
6.1 Screening Procedures  
 
All applicants will be screened by phone to determine whether they potentially meet eligibility 
criteria. We will obtain a waiver of written documentation of consent for the telephone screen. 
Those who remain interested in the trial will be scheduled for an in-person interview. The 
Weight and Lifestyle Inventory (WALI), an assessment of general eating and lifestyle behaviors, 
the Weight Bias Internalization Scale (WBIS), and the Beck Depression Inventory (BDI) will be 
mailed or emailed to eligible participants following the phone screen and completed by them 
prior to their screening/informed consent visit. The in-person interview will be conducted by a 
psychologist, who will obtain informed consent and evaluate participants’ behavioral eligibility 
(i.e., willingness and appropriateness to participate). This will include our assessment of the 
applicant’s mood (as measured by interview and the BDI) and suicidality (including history of 
suicidal ideation and behavior). Applicants who report active suicidal intent will be escorted to 
the emergency room at the Hospital of the University of Pennsylvania. (If applicants report 
suicidal intent while being screened by phone, they will be instructed to report to their nearest 
emergency room and/or to call the suicide hotline, for which the phone number will be provided 

 
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during the call. If applicants reporting suicidal intent by phone refuse to seek immediate help, a 
wellness check may be requested from the local police department.) 
 
Applicants who remain interested and pass the behavioral assessment will proceed to provide a 
medical history, which will be reviewed by the study physician or nurse practitioner to determine 
medical eligibility. Medical eligibility will be confirmed with blood test results. Applicants with 
a history of cardiac events or other significant CVD risk factors may also be asked to provide 
written verification from their primary care physician stating that they are healthy enough to 
participate in a weight loss program.  
 
Following completion of the screening visit, applicants will be required to complete food records 
for one week. Applicants will be provided with booklets or assisted in downloading a free mobile 
app to monitor their food intake over the course of the week. Applicants must return their 
completed food records (via mail or email) before being provisionally accepted into the study. 
Participants will be officially accepted into the study and randomized during a subsequent 
randomization visit that will occur within one month of beginning the study intervention. 
 
6.2 Study Visits 
 
Screening visit. The following procedures will be completed at the screening visit as discussed 
above: informed consent, medical history, weight, height, and meeting with psychologist whose 
assessment will be used as a part of determining the subject’s eligibility for the study. This 
medical history will be reviewed by the study physician or nurse practitioner to determine 
whether there are any contraindications to weight loss. These contraindications include but are 
not limited to: any major active kidney, liver, cardiovascular, or cerebrovascular disease; type 2 
diabetes; or the use of any medications that significantly affect weight (weight loss or weight 
gain, including steroids). Female participants will be ineligible for the study if they are pregnant 
or nursing. Applicants with a history of cardiac events or other significant CVD risk factors may 
also be asked to supply a letter from their primary care physician providing medical clearance for 
them to participate in this study. Applicants will be required to monitor their food intake 
following the screening visit and return their food records before being provisionally accepted 
into the study. 
 
Randomization visit. Within one month of the start of the group intervention, participants will 
attend a visit in which their weight and blood pressure will be measured and, if they still meet all 
study criteria, they will be randomized to their treatment group. Accelerometers will be given to 
participants to monitor their activity for 7-10 days. Participants will return their accelerometers 
in person, at which time their activity for the past week will be assessed with a structured 
interview. Participants may be held financially responsible if the accelerometer is lost, stolen, or 
not returned.  
 
If a participant is randomized but no longer able to attend groups as scheduled, it may be 
available to them to begin the group intervention, in the same treatment condition as assigned at 
randomization, in a subsequent cohort. In this case, baseline measurements will be repeated 
within one month of the start of treatment. 
 

 
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BWL intervention. Participants in this group will be provided with 20 weekly BWL sessions, 
based on the Diabetes Prevention Program (DPP) manual,59 followed by 6 monthly weight loss 
maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). A 
diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for 
those ≥ 250 lb.59,60 Participants will be instructed to eat a balanced deficit diet with approximately 
15-20% of kcal from protein, 20-35% from fat (less than 10% from saturated fat), and the 
remainder from carbohydrates.59 Session topics during the first 20 weeks will include self-
monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, 
and goal-setting.59 Those during weeks 21-72 will focus on continued self-monitoring and skills 
required for weight loss maintenance and relapse prevention. BWL sessions will last 90 minutes. 
Beginning at week 5, 60 minutes of the group session will be devoted to BWL content, with an 
additional 30 minutes devoted to discussing recipes and food preparation. 
 
Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is 
associated with improved long-term weight loss.12-14,61 Activity will begin at week 2 with 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 150-250 minute doses of activity equally across at least 5 days, and to 
accumulate their structured physical activity 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.  
 
Participants who cannot attend any given group session will be offered a brief (10-20 minute) 
make-up session (in person or by phone) during the week with the group leader or a study staff 
member. Participants may also meet briefly with the group leader individually, outside of group 
sessions, up to 3 times during the initial 20-week study period if they have not lost at least 1% of 
their body weight by week 4, report difficulty controlling their eating, or describe other challenges 
preventing them from adhering to the program that cannot be fully covered during group sessions.  
 
Stigma + BWL intervention. Participants in this group will receive the same BWL program 
described above, which will be combined with a stigma-reduction intervention. Beginning at 
week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related 
content. 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. 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.  
 

 
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As with the BWL Intervention, participants who cannot attend group sessions or are 
experiencing difficulties adhering to the program will be eligible for brief individual meetings 
with the group leader or study staff (as described above). 
 
Adjustments to treatment sessions due to COVID-19. During the pandemic, all group 
sessions will be conducted virtually on the platform BlueJeans. Group members who do not have 
access to video technology will be invited to join the meeting by phone. Makeup sessions will 
continue to be offered by phone. Treatment session handouts will be sent to participants by 
email. Since weight will no longer be measured in person at group meetings, all participants will 
be sent an EatSmart Precision Digital Scale. Prior to group meetings, participants will be asked 
to email the study coordinator their weight. This will allow the group leader and study team to 
continue to monitor participant weight loss for clinical purposes. 
 
Outcome assessment visits 
Participants will be expected to attend 4 assessment visits throughout the course of the study: at 
baseline, week 20, week 46, and week 72 (or within 4 weeks of each assessment period). Three 
of these assessment visits (baseline, week 20, and week 72) will include a fasting blood test, 
which will include a comprehensive metabolic panel (CMP), lipid panel, insulin, high sensitivity 
C-reactive protein (hs-CRP), and hemoglobin A1c. These tests will require approximately 34 mls 
of blood. Blood pressure, pulse, and waist measurement will also be measured at these outcome 
assessment visits, and weight will be measured at all assessment visits. 
 
Participants will also be asked to monitor their physical activity and complete questionnaires at 
baseline, week 20, week 46, and week 72. Questionnaires will be completed online or 
administered/returned via mail or at scheduled group sessions. Accelerometers will be 
administered at scheduled group sessions or assessment visits and returned in person or by mail, 
with an accompanying brief interview to assess activity over the past week (in person or by 
phone). 
 
Adjustments to outcome assessment visits due to COVID-19. During the pandemic, in-
person assessment visits will be replaced with remote assessments whenever possible. 
Specifically, all week 46 assessment visits will be conducted remotely for the duration of the 
pandemic. If permitted by the city, institution, and funding sponsor, week 20 and week 72 
assessment visits will be offered in-person, in order to allow for the measurement of blood 
pressure and a fasting blood test. All local and institutional safety regulations will be followed 
when conducting in-person visits. Participants with safety concerns or other barriers that prevent 
them from attending in-person assessment visits will be offered remote assessments without 
penalty.   
 
Remote assessment visits will be scheduled during the morning and will involve a brief 
phone call with the study coordinator, measurement of weight (and for weeks 20 and 72, 
measurement of waist circumference), monitoring of activity with an accelerometer device, and 
completion of online questionnaires. As described above, all participants will be sent an 
EatSmart Precision Digital Scale (with a tape measure included in the package). For remote 
assessments, participants will be asked to use the EatSmart scale to weigh themselves in 
duplicate, in kilograms, in the morning before eating anything. Participants will be asked to send 

 
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their weights to the study coordinator; when possible, they will be asked to take pictures of their 
weight with their phone, and then weigh their phone and send all information/pictures to the 
coordinator. For weeks 20 and 72 assessments, participants will also be provided with 
instructions to measure their waist circumference in duplicate with the EatSmart tape measure 
and will send their measurements to the study coordinator by email. For all remote assessments, 
accelerometer devices will be delivered to each participant’s home, and participants will be 
asked to begin to wear the device on the morning of their scheduled remote assessment. 
Participants will also be asked to complete their online questionnaires by the morning of their 
remote assessment. The study coordinator will have a brief phone call with each participant on 
the morning of their remote assessment to confirm that the weight/waist measurements have 
been received, the participant is wearing the accelerometer, and all questionnaires are completed. 
The coordinator will also conduct a brief assessment by phone of any changes in the participant’s 
health and medications since the last study visit, and the study nurse practitioner will follow up 
with participants about these changes as needed. Participants who complete either in-person or 
remote assessments will be able to return their accelerometers by mail using a prepaid shipping 
label. The study coordinator will schedule an additional phone call to instruct participants when 
to return the device and to conduct a brief interview assessing their physical activity over the past 
week.  
 
6.3 Outcome Measures 
 
Primary outcome. Percent weight loss from baseline to week 72 is the study’s primary outcome. 
At week 72, participants in the stigma + BWL intervention are predicted to maintain their 9% 
reduction in initial weight, as compared to a significantly smaller 5% reduction in the BWL 
alone group. Duplicate measures of height (with a wall-mounted stadiometer; Veeder-Root, 
Elizabethtown, NC) will be obtained at screening, and weight (with a digital scale; Detecto, 
model 6800A) will be measured at screening, randomization (baseline), and at weeks 20, 46, and 
72. Weight will also be measured at all group sessions. Percent weight loss from baseline to 
weeks 20 and week 46 will be assessed as secondary outcomes, along with categorical weight 
loss at weeks 72, 46, and 20 (loss of ≥5% and ≥10% of initial body weight at each time point). 
Participants in the BWL group are predicted to lose 8% of their initial weight at week 20. 
Participants in the stigma + BWL group are expected to lose 1% more of their initial weight 
(9%) at week 20 due to greater engagement in physical activity.  
 
Secondary outcomes.  
 
Physical activity. All participants will be given triaxial accelerometers (ActiGraph GT9X) 
to wear on their wrist for a 1-week period within 4 weeks of each assessment period (baseline and 
weeks 20, 46, and 72). Accelerometry has been used in numerous clinical trials,62-65 and the 
ActiGraph to be used in this study was adopted in the 5-year extension of the Look AHEAD study. 
Established activity counts will be used to identify thresholds of physical activity (sedentary, light, 
moderate, vigorous).66 Self-reported physical activity will be assessed with the Paffenbarger 
Physical Activity Questionnaire67 to obtain specific information on the types of activity 
participants engage in, and a brief questionnaire used in prior studies68 to collect data on sedentary 
behavior. Self-efficacy will be assessed with the Self-Efficacy for Exercise Scale69 Exercise 
Outcome Expectations and Barriers Scale (perceived barrier items only),70 and Weight and 

 
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Lifestyle Efficacy (WEL),71 which measure individuals’ confidence in their ability to overcome 
barriers to exercising and controlling their weight. Greater physical activity by objective and self-
report assessment is expected in the stigma + BWL intervention vs. BWL alone group at weeks 
20, 46, and 72. Based on prior research,13 we predict that participants in the stigma + BWL group 
will engage in approximately 250 min/wk of physical activity at week 72, as compared to 
approximately 150 min/wk in the BWL alone group, thus contributing to the 4% difference in 
weight loss at week 72. 
 
Cardiometabolic risk. Blood pressure, waist circumference, and blood samples 
(measures:  triglycerides, cholesterol, and glucose) will be obtained at screening and weeks 20 
and 72 to assess changes in cardiometabolic risk factors, particularly in the components and 
diagnosis of metabolic syndrome. Blood pressure also will be assessed at randomization. Blood 
pressure will be measured using an automated Dinamap monitor (Johnson & Johnson, XL model 
9300) at three, 1-minute intervals after ≥ 5 minute rest, using measures described previously.72 
Waist circumference will be measured (to the nearest 0.1 cm) in duplicate with flexible tension-
controlled measuring tape midway between the iliac crest and lowest rib. Blood samples will be 
drawn after an overnight fast to obtain plasma glucose levels and a lipid panel (triglycerides and 
HDL cholesterol), along with inflammatory markers of cardiometabolic risk (e.g., C-reactive 
protein). Samples will be sent to Quest Diagnostics (Horsham, PA) for analysis. Additionally, 
the study nurse practitioner or physician will review current medication use. Improvements in 
triglycerides, HDL cholesterol, and glucose are expected at week 20 in both treatment groups 
because of acute weight loss and calorie restriction. Due to higher levels of physical activity, 
greater weight loss, and reduced WBI, the magnitude of improvement is expected to be greater in 
the stigma + BWL intervention vs. BWL alone group at week 72.  
 
Weight bias coping and internalization. Participants will complete the WBIS (described 
previously) at screening and weeks 20, 46, and 72. In addition to scoring this measure on its 
continuous scale, the percentage of participants who do and do not meet the eligibility criterion 
cutoff score (4 or above) will be calculated at weeks 20, 46, and 72, as a measure of “remission” 
from elevated WBI. Participants will also complete additional measures of stigma, quality of life, 
stress, and depression at randomization and all subsequent assessment times. Stigma 
questionnaires will include the Weight Self-Stigma Questionnaire (WSSQ; an alternative 
measure of WBI),73 Fat Phobia Scale (a measure of stereotype endorsement),74 and the Everyday 
Discrimination Scale (an assessment of unfair treatment in daily life for a variety of reasons, 
including weight).75 The WBIS, WSSQ, Fat Phobia Scale, and Everyday Discrimination Scale 
are widely used and well validated.37,76-81 Additionally, an assessment of weight stigma coping 
strategies82 will be completed to assess the frequency with which participants engage in adaptive 
and maladaptive behaviors (e.g., exercising more vs. avoiding physical activity) in response to 
weight stigma. At baseline only, participants will complete the Weight Stigma Timing of Life 
Questionnaire to assess their history of weight-stigmatizing experiences, and the Adverse 
Childhood Experience Questionnaire to assess experiences of childhood trauma.83 Participants 
will also complete the Impact of Weight on Quality of Life Questionnaire-Lite (IWQOL),84 
which contains five subscales that include items assessing distress due to weight-stigmatizing 
situations and weight-based discrimination. Participants will complete the Perceived Stress Scale 
(PSS)85 to determine self-reported daily stress, the Questionnaire for Eating and Weight Patterns 
(QEWP)86 to assess disordered eating, and the Patient Health Questionnaire (PHQ-9)87 to assess 

 
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symptoms of depression. Participants will complete the Body Appreciation Scale88 to assess 
changes in body positivity. Additionally, participants will complete a brief questionnaire 
assessing the frequency with which they self-monitor their weight and eating (along with food 
records which will be collected from participants at all group meetings to assess days of recorded 
food intake and activity), and treatment acceptability will be assessed at weeks 20 and 72. 
Participants in the stigma + BWL intervention group are predicted to show greater reductions in 
all measures of stigma and distress than participants in the BWL group at weeks 20, 46, and 72.  
 
6.4 Safety Measures 
 
Risks 
The risk of adverse medical or psychiatric events should be minimized by the careful screening 
procedures to be used. The principal risks during the group lifestyle modification program 
include: 
 
Risk of gallstones. Rapid weight loss may increase the risk of gallstones. The risk of gallbladder 
disease will be reduced by limiting weight loss to no more than 3 pounds per week for 4 
consecutive weeks. Weight loss will be monitored at all group sessions. Patients will be asked to 
slow or stop their weight loss if there are concerns about the rate of their weight loss. 
 
Blood draw. Risks of drawing blood include pain, bruising at the puncture site, swelling, feeling 
faint or lightheaded, and rarely infection. 
 
Psychological distress. Participants may become distressed by learning about and discussing 
their experiences with weight-based discrimination and stigma. 
  
Confidentiality and loss of privacy. All efforts will be made to protect participant 
confidentiality and privacy. We cannot guarantee total privacy. Personal information may be 
given out if required by law.  
 
Ongoing medical visits and safety measures 
A physician/nurse practitioner will be available if participants notice any side effects of weight 
loss. Participants who lose 15% or more of their initial body weight may be advised to inform 
their PCP of their weight loss, particularly if taking medications that may need to be adjusted due 
to weight loss (e.g., anti-hypertensive medications). Participants who report significant 
depression or emotional distress will be evaluated by the study’s psychologist or psychiatrist and 
referred to their PCP for further evaluation and treatment. Participants will be referred to their 
PCP if their mood is significantly disrupting their normal function (as reflected by symptoms that 
include feeling blue, not enjoying usual activities, trouble sleeping or concentrating, or having 
thoughts of dying or harming oneself). 
 
7. STATISTICAL ANALYSIS 
 
Sample size calculation 
Using a sample size equation for longitudinal clustered samples,84 a power analysis was conducted 
for the primary outcome: percent weight change at week 72. Estimated group means, attrition 
rate, intraclass correlation (ICC), and variances were derived from data from prior studies 

 
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conducted at our Center.72 Specifically, we predict a 72-week weight loss of 9% in the stigma + 
BWL group and 5% in the BWL group, with expected standard deviations of 7%.72 Based on these 
estimates, a baseline sample size of 104 participants (52 per group), assuming a 20% attrition rate, 
an ICC of .80, and 4 assessment points, will give us 80% power to detect a between-treatment 
group difference at week 72 of 4% (effect size: 0.57) to be significant at alpha = 0.05. The power 
analysis was conducted using PASS v14. All secondary outcomes will be considered exploratory 
and will provide valuable findings that will help to inform larger studies. This study has not been 
powered to detect differences in changes in physical activity, cardiometabolic outcomes, or 
psychosocial variables. 
 
Analysis plan 
Data quality and integrity will be checked by assessing the data for missing and out-of-range values 
with basic statistical procedures, including univariate statistics and visual graphical displays (e.g., 
scatter plots). We will investigate all questions of data quality and integrity prior to performing 
any statistical modeling. To test the adequacy of randomization, preliminary analyses will include 
a comparison of all participant demographic and baseline characteristics by randomized treatment 
groups (t-tests or Wilcoxon rank sum tests for continuous variables and Chi-Square test or Fisher’s 
Exact test for categorical data). If imbalances are observed, the relevant variables will be included 
as covariates in the final analyses. 
 
All data will be analyzed with a modified intention-to-treat principle. Participants who attend at 
least one group meeting (i.e., receive a dose of treatment) will be included in the analyses; 
participants who do not attend a single group meeting will not be included in the analyses. 
Analyses will be two-tailed with a significance level of 0.05, and will be conducted using SPSS 
version 24.0 or SAS version 9.4. To assess the primary outcome of percent weight change by 
treatment group, a mixed effects model will be fit with Treatment Group (stigma+BWL, BWL) as 
a between subjects factor and Time (Weeks 20, 46, 72) as a categorical within-subjects factor. We 
will use the group x time interactions with the time main effect to estimate and test treatment group 
differences at each time point, with the 72-week time point as our primary test. In fitting a mixed 
effects model with residual maximum likelihood (REML), a variance-covariance structure must 
be selected. The criteria for selecting the best form of the variance-covariance structure will be 
based on criteria such as the Akaike’s Information Criterion (AIC). We will include as baseline 
covariates any variables that differ significantly between the treatment groups at baseline and show 
significant relationships with the outcome. The results from the mixed model will be summarized 
by mean(SE) for each treatment group at each time point. Residual analyses will be conducted to 
check for outliers and influential points and violations in the normality assumption. If violations 
are detected, variance-stabilizing transformations will be considered. Logistic regression will be 
used to test for between-group differences in categorical weight loss (≥5% and ≥10% of initial 
body weight) at weeks 72, 46, and 20.  
 
The second aim of assessing changes in physical activity and self-efficacy, and the secondary aims 
of comparing changes in cardiometabolic risk factors and psychological well-being (including 
WBI), will be analyzed using the same methods as described above for the mixed effects model 
used for the primary aim. Changes in all outcomes will be summarized by mean(SE) for each 
treatment group at each time point. Logistic regression will be used to test for between-group 

 
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differences at weeks 20, 46, and 72 in the percentage of participants who have remitted from 
elevated WBI, as indicated by no longer having a score of 4 or above. 
 
This study will consider death, pregnancy, bariatric surgery, amputation, and other major medical 
events or procedures that require a participant to terminate treatment as "censoring events." For 
primary analyses, participants experiencing these events will be censored at the last measured 
weight before the event occurred. As discussed above, the primary analysis techniques being 
employed (i.e., linear mixed models) can accommodate incomplete participant response profiles, 
so these participants will still be included in the analyses. Additional sensitivity analyses may be 
conducted in which data will be censored due to other factors that directly affect weight (e.g., 
change of medication that affects weight, receipt of additional weight-related treatment, change in 
smoking status, or other major medical changes that occur within 3 months of an assessment visit). 
 
Additional analyses may be conducted to explore potential effects of cohort, time of group 
meeting, and group leader on weight loss and changes in WBI. Analyses may also explore potential 
differences in attendance between groups and the effects of attendance on weight loss and changes 
in WBI. 
 
8. SAFETY AND ADVERSE EVENTS 
 
At each contact with participants, the study personnel will seek information on adverse events by 
specific questioning and, as appropriate, by physical examination. Information on all adverse 
events will recorded immediately in the source document, and also in the appropriate adverse 
event module of the case report form (CRF). All clearly related signs, symptoms, and abnormal 
diagnostic procedures results will be recorded in the source document, though should be grouped 
under one diagnosis. 
 
All adverse events occurring during the study period will be recorded. The clinical course of 
each event will be followed until resolution, stabilization, or until it has been determined that the 
study treatment or participation is not the cause. Serious adverse events that are still ongoing at 
the end of the study period will be followed up to determine the final outcome.  Any serious 
adverse event that occurs after the study period and is considered to be possibly related to the 
study treatment or study participation will be recorded and reported immediately. All serious 
adverse events will be reported to the IRB within 10 working days.  
 
9. DATA HANDLING AND RECORD KEEPING 
 
Information about study participants will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the following:  
 
• Protected health information (PHI) collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information 
• The rights of research participants to revoke their authorization for use of their PHI 

 
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• View of PHI will be limited to individuals at the University of Pennsylvania directly 
involved in the study. The company donating the study product will not have access to 
PHI.  
 
In the event that a participant revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of subject 
authorization. For participants who have revoked authorization to collect or use PHI, attempts 
will be made to obtain permission to collect at least vital status (i.e. that the subject is alive) at 
the end of their scheduled study period. 
 
10. STUDY MONITORING, AUDITING, AND INSPECTING 
 
The investigator will permit study-related monitoring, audits, and inspections by the EC/IRB, 
government regulatory bodies, and University compliance and quality assurance groups of all 
study related documents (e.g. source documents, regulatory documents, data collection 
instruments, study data, etc.).  The investigator will ensure the capability for inspections of 
applicable study-related facilities (e.g. pharmacy, diagnostic laboratory, etc.). 
 
A Data Safety and Monitoring Board (DSMB) consisting of at least one external (non-Center) 
reviewer will be assembled to provide additional study oversight. Members of the DSMB will 
meet twice per year to review the study’s progress, enrollment, and de-identified group-level 
data for differential rates in key outcomes and Adverse Events (AEs). This team will be 
responsible for monitoring the safety and efficacy of this trial, executing the data safety and 
monitoring (DSM) plan, and complying with Public Health Service (PHS) reporting 
requirements. Review of the rate of subject accrual and adherence to inclusion/exclusion criteria 
will occur at this time. 
 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable University compliance and quality assurance 
offices. 
 
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