A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
Phase: NA
Conditions: Stigmatization, Obesity, Weight Loss
Sponsor: University of Pennsylvania

IRB Approval: March 1, 2019 
 
 
 
Title: A Randomized Controlled Trial of a 
Psychological Intervention to Reduce Weight Bias 
Internalization in the Context of Behavioral Weight Loss 
 
IRB #829070 
 
NCT03572218 
 
 
 

2 
Version 1.8 February 2019 
University of Pennsylvania 
Center for Weight and Eating Disorders 
3535 Market Street Suite 3108 
Philadelphia, PA 19104 
Phone: 215-898-7314 
Fax: 215-898- 2878 
 
 
Title: A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight 
Bias Internalization in the Context of Behavioral Weight Loss 
 
Principal Investigator:  
Rebecca L. Pearl, Ph.D. 
 
Co- Investigator: 
  
Thomas A. Wadden, Ph.D. 
 
Study Site:  
 
 
Center for Weight and Eating Disorders 
                      
 
University of Pennsylvania 
 
1. STUDY OBJECTIVE 
To evaluate, in a 16-session (26 week) randomized controlled trial, the efficacy of a 
psychological intervention, combined with behavioral weight loss (BWL), on reducing weight 
bias internalization (WBI). 
 
2. BACKGROUND 
 
2.1 Weight bias and stigma are pervasive.  
The term weight stigma refers to societal scorn and devaluation of individuals with 
overweight and obesity.1 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; 
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.2-6   
 
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.7,8 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.9 A recent large-scale study estimated that 
approximately 40% of US adults internalize weight bias to some extent, and 20% to a high 
degree.10  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).11 For example, someone who is unable to successfully maintain weight loss may 

3 
Version 1.8 February 2019 
attribute weight regain to laziness and weakness, and have lower self-esteem due to assigning 
these stereotypical characteristics to oneself.   
 
2.2 Weight bias internalization contributes to poor mental and physical health. 
Higher levels of WBI are also associated with more symptoms of psychopathology (e.g., 
depression) and poorer mental and physical health-related quality of life (HRQOL).9,12-14 Prior 
research suggests that WBI is a better predictor of psychological distress and poor health than is 
exposure to weight stigma alone.15,16 For example, Latner et al found that only WBI, and not 
perceived weight discrimination, was associated with worse health-related quality of life for 
individuals with high BMIs.17 Studies also suggest that internalizing stigma may increase risk for 
poor cardiometabolic health.18-20 In a study recently published in Obesity,21 my colleagues and I 
demonstrated that WBI was associated with heightened risk for metabolic syndrome and high 
triglycerides among treatment-seeking individuals with obesity. Specifically, when controlling 
for BMI, depression and demographic variables, individuals categorized as having high WBI 
were three times more likely to have metabolic syndrome and six times more likely to have high 
triglycerides, than were individuals with low levels of WBI.  
 
2.3 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 obese22 and gained 1.7 more kg than individuals who did 
not report weight discrimination.23 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.24-27 
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.24 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.21 
 
Acute and long-term studies have shown that weight stigma (particularly WBI) is 
associated with reduced self-efficacy for dietary control,28 with increased caloric consumption 
(particularly of unhealthy foods),28-30 and with worse dietary adherence following bariatric 
surgery.31 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.32-34 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.35 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 weight management-related behavioral goals and are, 
thus, less likely to engage in their planned healthy behaviors (e.g., physical activity).35,36  
 
 
 

4 
Version 1.8 February 2019 
2.4 Addressing weight stigma in weight loss interventions. 
Weight stigma is not addressed as part of standard behavioral weight loss treatment. The 
few studies that have investigated the effects of weight loss on WBI have found an approximate 
½ point reduction on the 7-point Weight Bias Internalization Scale following BWL,37,38 
suggesting minimal improvement. This is consistent with prior research showing that the benefits 
of weight loss tend to be greater for physical health than for mental health and other aspects of 
psychosocial functioning 39,40. In contrast to BWL, recent preliminary evidence suggests that 
targeted psychological interventions may reduce WBI in patients with obesity. A pilot study of 
the Weight Bias Internalization and Stigma (BIAS) program showed that, in 8 patients with 
obesity and high levels of WBI, an 8-week cognitive-behavioral intervention reduced scores on 
the WBIS by approximately 1 point.41 This change was significantly greater than that found in a 
quasi-control group of 6 patients (partial eta2 = .36). The BIAS program also led to significantly 
greater reductions in negative stereotype endorsement (partial eta2 = .39) and increases in weight 
self-efficacy (partial eta2 = .47) than the quasi-control group. 
 
Additionally, weight losses achieved with BWL treatment are not maintained, on 
average, in the long-term.42,43 Weight regain may be associated with deterioration in HRQOL 
and increases in WBI. 44,45  An intervention that combines traditional BWL with a program to 
reduce WBI could produce clinically meaningful short- and long-term reductions in self-
stigmatization, along with other psychological benefits, that persist independent of weight loss 
and regain. Additionally, given, the evidence reviewed that individuals who have experienced 
and/or internalized weight stigma have reduced self-efficacy for and engagement in weight 
management behaviors (e.g., physical activity), an intervention targeting weight stigma may 
improve long-term weight loss. Overall, an intervention that incorporates elements from both 
BWL and stigma-reduction approaches could provide patients with multifaceted health benefits. 
 
3. SPECIFIC AIMS 
 
Aim 1. To test, in a 16-session (26-week) randomized controlled trial of 72 adults with obesity 
and high levels of WBI, the effects on weight bias internalization (WBI) of the BIAS program 
combined with behavioral weight loss (BWL), in comparison to BWL alone. 
H1a: Participants who receive BWL + BIAS program will show significantly greater reductions 
in WBI after 12 weekly sessions than participants who receive BWL alone. 
H1b: Participants in the BWL + BIAS program will continue to show greater improvements in 
WBI at 26 weeks (following an additional 2 biweekly sessions and 2 monthly sessions), 
compared to participants in the BWL group. 
 
Aim 2. To explore the effects of BWL + BIAS program, compared to BWL alone, on depression, 
perceived stress, health-related quality of life, and weight-related self-efficacy. 
H2: Participants in the BWL + BIAS program will show greater improvements in depression, 
perceived stress, health-related quality of life, and weight self-efficacy than participants in the 
BWL group at 12 and 26 weeks. 
 
Secondary Aims 
 
Aim 3. To examine the effects of BWL + BIAS program, compared to BWL alone, on weight 
loss. 

5 
Version 1.8 February 2019 
H3: Participants in the BWL + BIAS program will have a higher percent weight loss than 
participants in the BWL group at 26 weeks. 
 
Aim 4. To examine the effects of BWL + BIAS program, compared to BWL alone, on 
cardiometabolic risk factors. 
H4: Participants in the BWL + BIAS program will sustain greater reductions in blood pressure 
and waist circumference than participants in the BWL group at 26 weeks.   
 
Aim 5.  To compare the effects of the BWL+BIAS program versus BWL alone on WBI, 
psychosocial outcomes (e.g., depression), weight, and cardiometabolic risk factors at week 52. 
H5: Participants in the BWL + BIAS program will sustain greater improvements on all outcomes 
than participants in the BWL group at 52 weeks. 
 
4. STUDY DESIGN 
 
4.1 General Design 
This is a randomized controlled trial to test the effects on WBI of a novel psychological 
intervention combined with standard BWL treatment, as compared to BWL alone. Participants 
will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass 
index (BMI) of 30 kg/m2 or above, 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 = 36) or the BWL + 
BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 
weeks (12 visits). In the BWL + BIAS intervention, 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 12 weeks of weight loss 
treatment, participants will attend group meetings focused on weight loss maintenance, every-
other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance 
sessions in the BWL + BIAS group will continue to incorporate discussion of WBI. Assessments 
– which include questionnaires and measurements of body weight – will occur at baseline and 
weeks 12 and 26. Additional assessments will also occur at week 52. Weight will be measured at 
every group meeting for clinical purposes. 
 
Other Medical Therapies: 
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. In all cases, the subjects’ primary 
care provider (PCP) 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. 
 

6 
Version 1.8 February 2019 
5. PARTICIPANT SELECTION 
 
5.1 Participant Recruitment 
 
 
Participants will be recruited from advertisements in local media outlets (newspapers, radio), 
as well as flyers posted at the University.  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.46  
 
5.2 Inclusion/Exclusion Criteria 
 
 Key Inclusion Criteria  
Eligible participants will be men and women ages 18-65 years. Participants must have 
obesity (defined as a BMI ≥ 30 kg/m2); 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)9 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.47  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, evidenced by a negative urine dipstick pregnancy test 
 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 with which to participate in conference calls 
 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: 
Applicants will be excluded if they have: a diagnosis of type I or II diabetes; uncontrolled 
hypertension (blood pressure ≥ 160/100 mm Hg); experienced a cardiovascular event (e.g., 
stroke, myocardial infarction) in the last 12 months; lost ≥ 5% of their initial weight in the last 6 
months; or have participated in individual or group psychotherapy in the last 3 months (due to 
the potentially confounding effects of receiving a simultaneous cognitive-behavioral 
intervention). Applicants who have recently participated in or are currently receiving counseling 
for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; 
caregiver support) may be eligible per Principal Investigator’s discretion. Applicants with severe 
symptoms of mood (for example, 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 

7 
Version 1.8 February 2019 
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 12 
months are not eligible to participate. 
 
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), a paper-and-pencil inventory that assesses general 
eating and lifestyle behaviors, the Weight Bias Internalization Scale (WBIS; 11 items, rated 1-7), 
and the Beck Depression Inventory (BDI) will be mailed 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).  
 
Participants who remain interested and pass this portion of the assessment will proceed to 
provide a medical history, which will be reviewed by the study physician or nurse practitioner to 
determine medical eligibility. Participants may be asked to also provide medical clearance from 
their primary care physician, upon request from the study physician or nurse practitioner.  
 
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 
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. Upon request from the study physician or nurse practitioner, 
participants may also be asked to supply a letter from their primary care physician providing 
medical clearance for them to participate in this study. 
 
6.2 Randomization 
 
Following the screening visit, participants who meet all eligibility criteria and provide 
informed consent will be randomized to one of the two treatment groups in a 1:1 ratio by a 
biostatistician. Investigators and participants will not be blinded to participants’ assigned 

8 
Version 1.8 February 2019 
conditions. 
 
6.3 BWL Intervention 
Participants in this group will be provided with 12 weekly BWL sessions, based on the 
Diabetes Prevention Program (DPP) manual,48 followed by 2 every-other-week weight loss 
maintenance sessions and 2 monthly sessions (for a total of 16 visits over 26 weeks). A diet of 
1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those 
≥ 250 lb.48,49 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.48 Session topics during the first 12 weeks will include self-monitoring, 
stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-
setting.48 Those during weeks 13-26 will focus on continued self-monitoring and skills required 
for weight loss maintenance and relapse prevention. BWL sessions will last 60 minutes, 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.50-53 Activity will begin at week 2 with 
60 min/wk, and will gradually progress by 10 minutes over 1-2 week intervals until achieving 150 
min/wk by week 12, and 200-250 min/wk by week 26. 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 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 12-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.  
 
6.4 BWL + BIAS Intervention 
Participants in this group will receive the same BWL program described above, which 
will be combined with a stigma-reduction intervention. During the initial 12 weeks, 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 weight management. 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 engaging in physical activity. These concrete strategies, 
along with reducing WBI and improving self-confidence, are intended to increase participants’ 
self-efficacy for and engagement in weight management behaviors. In the every-other-week and 
monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight 

9 
Version 1.8 February 2019 
stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged 
to use these strategies specifically in the context of weight management.  
 
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). 
 
6.5 Outcome Assessment Visits 
Participants will be expected to attend 3 assessment visits throughout the course of the 
study: at baseline, week 12, and week 26. Blood pressure, pulse, weight, and waist measurement 
will be measured at all outcome assessment visits. Questionnaires will also be completed online 
or administered/returned via mail or at scheduled group sessions.  
 
In addition to the main assessment visits, participants will be invited to complete another 
assessment at week 52. Participants will be asked to complete online questionnaires and, if 
available, attend an assessment visit.  
 
6.6 Outcome Measures 
Primary outcome. Weight bias internalization. Participants will complete the WBIS 
(described previously) at screening and weeks 12 and 26 (as well as at week 52). Secondary 
weight bias and stigma questionnaires will include the Fat Phobia Scale (a measure of stereotype 
endorsement)54 and the Weight Self-Stigma Questionnaire (WSSQ),55 which is another measure 
of weight bias internalization. The WBIS, Fat Phobia Scale, and WSSQ are widely used and well 
validated.22,56-61 Additionally, an assessment of weight stigma coping strategies62 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, participants will also complete the Everyday Discrimination Scale, which is a 10-item 
assessment of unfair treatment in daily life for a variety of reasons including weight,63 and the 
Weight Stigma Timing of Life Questionnaire developed for this study assessing experiences of 
weight stigma at different developmental stages.  
 
Secondary outcomes. Participants will complete the Impact of Weight on Quality of Life 
Questionnaire-Lite (IWQOL),64 which contains five subscales that include items assessing 
distress due to weight-stigmatizing situations and weight-based discrimination. Participants will 
also complete the Perceived Stress Scale (PSS)65 to determine self-reported daily stress, the 
Eating Disorders Examination Questionnaire (EDE-Q)66 to assess disordered eating, the Patient 
Health Questionnaire (PHQ-9)67 to assess symptoms of depression, and the Generalized Anxiety 
Disorder-7 questionnaire68 to assess symptoms of anxiety. Participants will also complete the 
Appearance Subscale of the Multidimensional Body-Self Relations Questionnaire (MBSRQ-
AS)69 and the Body Appreciation Scale70 as measures of body image, and the Rosenberg Self-
Esteem Scale. Rejection sensitivity will also be measured at baseline, and treatment acceptability 
will be assessed at week 26. Participants in the BWL + BIAS intervention group are predicted to 
show greater reductions in all measures of stigma and distress than participants in the BWL 
group at weeks 12 and 26 (and at week 52).  
 

10 
Version 1.8 February 2019 
We will also assess for potential changes in self-efficacy for and engagement in healthy 
weight management behaviors. Self-efficacy will be assessed with the Self-Efficacy for Exercise 
Scale71 and Weight and Lifestyle Efficacy-Short Form (WEL-SF),72 which measure individuals’ 
confidence in their ability to overcome barriers to exercising and controlling their weight. 
Questionnaires will assess changes in self-reported eating (e.g., the Eating Inventory 
Questionnaire73) and exercise motivation. Self-reported physical activity will be assessed with the 
International Physical Activity Questionnaire (IPAQ).74 Weekly food records of daily caloric 
intake will also be collected for all participants. Greater self-efficacy for and self-reported dietary 
adherence and physical activity are expected in the BWL + BIAS intervention vs. BWL group at 
weeks 12 and 26 (and at week 52).  
 
Percent weight loss from baseline to week 26 (and to week 52) will be an exploratory 
outcome. 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, baseline (week 1) and at weeks 12 and 26. Weight 
will also be measured at all group sessions. To determine potential changes in cardiometabolic 
risk in response to the BIAS program, 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.75 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. Participants in the BWL + BIAS group are expected to maintain 
greater weight loss and, thus, greater cardiometabolic improvements at week 26 than participants 
receiving BWL alone. 
 
6.7 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 3 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. 
 
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 report significant depression or emotional distress will be 

11 
Version 1.8 February 2019 
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 
 
7.1 Sample Size Calculation 
A power analysis was conducted for the primary outcome: reduction in Weight Bias 
Internalization Scale (WBIS) scores at week 12. Estimated group means, attrition rate, intraclass 
correlation (ICC), and variances were derived from data from prior studies conducted at our 
Center.75 Specifically, we predict a 12-week reduction of 1.5 points on the WBIS in the BWL + 
BIAS group and 1 point in the BWL group, with expected standard deviations of 1.37,38,41 Based 
on these estimates, a baseline sample size of 72 participants (36 per group), assuming a 20% 
attrition rate, will give us 95% power to detect a between-treatment group difference at week 12 
of 1 point to be significant at alpha = 0.05. The power analysis was conducted using G*Power 2. 
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 
other psychosocial and behavioral outcomes, weight loss, and cardiometabolic outcomes. 
 
7.2 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 under the intention-to-treat principle. 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. Participants who were randomized but did not attend a group meeting will not be included in 
the analyses, as they will not have received a dose of treatment. We will include as baseline 
covariates any variables that differ significantly between the treatment groups at baseline and show 
significant relationships with the outcome. To assess changes in WBIS scores across the 26-week 
trial, a mixed effects model will be fit with Treatment Group (BWL+BIAS, BWL) as a between 
subjects factor and Time (Weeks 12 and 26) 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. 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). 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 

12 
Version 1.8 February 2019 
influential points and violations in the normality assumption. If violations are detected, variance-
stabilizing transformations will be considered.   
 
The second aim of assessing changes in other psychosocial and behavioral outcomes, and 
the secondary aims of assessing changes in weight loss and cardiometabolic risk factors, will be 
analyzed using the same methods as described above. Changes in all outcomes will be summarized 
by mean (SE) for each treatment group at each time point. 
 
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 
 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 

13 
Version 1.8 February 2019 
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 Monitor (consisting of a reviewer not involved in the study) will 
provide additional study oversight. Before beginning the study, the Monitor will review the 
human subjects’ protections. The Monitor will review the study’s progress, enrollment, and de-
identified group-level data for differential rates in key outcomes and Adverse Events (AEs) twice 
per year. This Monitor 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. 
 
 
 
 
 
 
 
 
 
 
 
 

14 
Version 1.8 February 2019 
11. REFERENCES 
1. 
Puhl RM, Brownell KD. Psychosocial origins of obesity stigma: Toward changing a powerful and 
pervasive bias. Obesity Reviews 2003;4:213-27. 
2. 
Ata RN, Thompson JK. Weight Bias in the Media: A Review of Recent Research. Obesity Facts 2010;3:41-
6. 
3. 
Gortmaker SL, Must A, Perrin JD, Sobol AM, Dietz WH. Social and economic consequences of 
overweight in adolescence and young adulthood. The New England Journal of Medicine 1993;329:1008-12. 
4. 
Puhl RM, Heuer CA. The stigma of obesity:  A review and update. Obesity 2009;17:941-64. 
5. 
Puhl R, Brownell KD. Bias, discrimination, and obesity. Obesity Research 2001;9:788-805. 
6. 
Puhl RM, Brownell KD. Confronting and Coping with Weight Stigma: An Investigation of Overweight and 
Obese Adults. Obesity 2006;14:1802-15. 
7. 
Andreyeva T, Puhl RM, Brownell KD. Changes in Perceived Weight Discrimination Among Americans, 
1995-1996 Through 2004-2006. Obesity 2008;16:1129-34. 
8. 
Puhl RM, Andreyeva T, Brownell KD. Perceptions of weight discrimination: Prevalence and comparison to 
race and gender discrimiation in America. International Journal of Obesity 2008;32:992-1000. 
9. 
Durso LE, Latner JD. Understanding self-directed stigma: Development of the Weight Bias Internalization 
Scale Obesity 2008;16:S80-S6. 
10. 
Puhl R, Himmelstein M, Quinn D. Internalizing weight sitgma: Prevalence and sociodemographic 
considerations in US adults. Obesity 2017. 
11. 
Corrigan PW, Watson AC, Barr L. The self-stigma of mental illness: Implications for self-esteem and self-
efficacy. Journal of Social and Clinical Psychology 2006;25:875-84. 
12. 
Pearl RL, White MA, Grilo CM. Weight bias internalization, depression, and self-reported health among 
overweight binge eating disorder patients. Obesity 2014;22:E142-8. 
13. 
Latner JD, Durso LE, Mond JM. Health and health-related quality of life among treatment-seeking 
overweight and obese adults: associations with internalized weight bias. Journal of Eating Disorders 2013;1. 
14. 
Hilbert A, Braehler E, Haeuser W, Zenger M. Weight bias internalization, core self-evaluation, and health 
in overweight and obese persons. Obestiy 2014;22:79-85. 
15. 
Pearl RL, Puhl RM. The distinct effects of internalizing weight bias: An experimental study. Body Image 
2016;17:38-42. 
16. 
O'Brien KS, Latner JD, Puhl RM, et al. The relationship between weight stigma and eating behavior is 
explained by weight bias internalization and psychological distress. Appetite 2016;102:70-6. 
17. 
Latner JD, Barile JP, Durso LE, O'Brien KS. Weight and health-related quality of life: The moderating role 
of weight discrimination and internalized weight bias. Eating Behaviors 2014;15:586-90. 
18. 
Tull ES, Wickramasuriya T, Taylor J, et al. Relationship of internalized racism to abdominal obesity and 
blood pressure in Afro-Caribbean women. Journal of the National Medical Association 1999;91:447-52. 
19. 
Wyatt SB, Williams DR, Calvin R, Henderson F, Walker ER, Winters K. Racism and cardiovascular 
disease in African Americans. American Journal of the Medical Sciences 2003;325:3150331. 
20. 
Tomiyama AJ, Epel ES, McClatchey TM, et al. Associations of weight stigma with cortisol and oxidative 
stress independent fo adiposity. Health Psychology 2014;33:862-7. 
21. 
Pearl RL, Wadden TA, Hopkins CM, et al. Association between weight bias internalization and metabolic 
syndrome among treatment-seeking individuals wtih obesity. Obesity 2017;25:317-22. 
22. 
Sutin AR, Terracciano A. Perceived Weight Discrimination and Obesity. PLos ONE 2013;8. 
23. 
Jackson SE, Beeken RJ, Wardle J. Perceived weight discrimination and changes in weight, waist 
circumferance, and weight status. Obesity 2014;22:2485-8. 
24. 
Wott CB, Carels RA. Overt Weight Stigma, Psychological Distress and Weight Loss Treatment Outcomes. 
Journal of Health Psychology 2010;15:608-14. 
25. 
Gudzune KA, Bennett WL, Cooper LA, Bleich SN. Perceived judgment about weight can negatively 
influence weight loss: A cross-sectional study of overweight and obese patients. Prev Med 2014;62:103-7. 
26. 
Lent MR, Napolitano MA, Wood GC, et al. Internalized weight bias in weight-loss surgery patients: 
psychosocial correlates and weight loss outcomes. Obesity Surgery 2014;24:2195-59. 
27. 
Carels RA, Young KM, Wott CB, et al. Weight Bias and Weight Loss Treatment Outcomes in Treatment-
Seeking Adults. Annals of Behavioral Medicine 2009;37. 
28. 
Major B, Hunger JM, Bunyan DP, Miller CT. The ironic effects of weight stigma. Journal of Experimental 
Social Psychology 2014;51:74-80. 
29. 
Schvey NA, Puhl RM, Brownell KD. The Impact of Weight Stigma on Caloric Consumption. Obesity 
2011;19:1957-62. 

15 
Version 1.8 February 2019 
30. 
Durso LE, Latner JD, Hayashi K. Perceived Discrimination is Associated with Binge Eating in a 
Community Sample of Non-Overweight, Overweight, and Obese Adults. Obesity Facts 2012;5:869-80. 
31. 
Raves DM, Brewis A, Trainer S, Han S, Wutich A. Bariatric surgery patients' perceptions of weight-related 
stigma in healthcare settings impair post-surgery dietary adherence. Frontiers in Psychology 2016;7:1497. 
32. 
Seacat JD, Mickelson KD. Stereotype threat and the exercise/dietary health intentions of overweight 
women. Journal of Health Psychology 2009;14:556-67. 
33. 
Vartanian LR, Shaprow JG. Effects of weight stigma on exercise motivation and behavior: a preliminary 
investigation among college-aged females. Journal of Health Psychology 2008;13:131-8. 
34. 
Vartanian LR, Novak SA. Internalized societal attitudes moderate the impact of weight stigma on 
avoidance of exercise. Obesity 2011;19:757-62. 
35. 
Pearl RL, Puhl RM, Dovidio JF. Differential effects of weight bias experiences and internalization on 
exercise among women with overweight and obesity. Journal of Health Psychology 2015;20:1626-32. 
36. 
Hubner C, Baldofski S, Zenger M, et al. Influences of general self-efficacy and weight bias internalization 
on physical activity in bariatric surgery candidates. Surgery for Obesity and Related Disorders 2015;11:1371-6. 
37. 
Mensinger JL, Calogero RM, Tylka TL. Internalized weight stigma moderates eating behavior outcomes in 
women with high BMI participating in a healthy living program. Appetite 2016;102:32-43. 
38. 
Carels RA, Wott CB, Young KM, Gumble A, Koball A, Oehlhof MW. Implicit, explicit and internalized 
weight bias and psychological maladjustment among treatment-seeking adults. Eating Behaviors 2010;11:180-5. 
39. 
Warkentin L, Das D, Majumdar S, Johnson J, Padwal R. The effect of weight loss on health-related quality 
of life: Systematic review and meta-analysis of randomized trials. Obesity Reviews 2014;15:169-82. 
40. 
Rubin R, Peyrot M, Wang N, et al. Patient-reported outcomes in the practice-based opportunities for weight 
reduction (POWER) trial. Quality of Life Research 2013;22:2389-98. 
41. 
Pearl RL, Hopkins CM, Berkowitz RI, Wadden TA. Group cognitive-behavioral treatment for internalized 
weight stigma: A pilot study. Eating and Weight Disorders 2016;Advance online publication. 
42. 
Jeffery RW, Epstein LH, Wilson GT, et al. Long-term maintenance of weight loss: Current status. Health 
Psychology 2010;19:5-16. 
43. 
Wadden TA, Crerand CE, Brock J. Behavioral Treatment of Obesity. Psychiatric Clinics of North America 
2005;28:151-70. 
44. 
Foster G, Wadden T, Kendall P, Stunkard A, Vogt R. Psychological effects of weight loss and regain: A 
prospective evaluation. Journal of Consulting and Clinical Psychology 1996;64:752-7. 
45. 
Engel S, Crosby R, Kolotkin R, et al. Impact of weight loss and regain on quality of life: Mirror image or 
differential effect? Obesity 2003;11:1207-13. 
46. 
Wadden TA, Volger S, Sarwer DB, et al. A two-year randomized trial of obesity treatment in primary care 
practice. The New England journal of medicine 2011;365:1969-79. 
47. 
Papadopoulos S, Brennan L. Correlates of weight stigma in adults with overweight and obesity: A 
systematic literature review. Obesity 2015;23:1743-60. 
48. 
TheDiabetesPreventionProgram(DPP)ResearchGroup. The Diabetes Prevention Program (DPP). Diabetes 
Care 2002;25:2165-71. 
49. 
Wadden T, West D, Delahanty L, et al. The Look AHEAD study: A description of the lifestyle intervention 
and the evidence supporting it. Obesity 2006;14:737-52. 
50. 
Jakicic JM, Marcus BH, Gallagher KI, Napolitano M, Lang W. Effect of exercise duration and intensity on 
weight loss in overweight, sedentary women. JAMA 2003;290:1323-30. 
51. 
Jakicic JM, Winters C, Lang W, Wing RR. Effects of intermittent exercise and use of home exercise 
equipment on adherence, weight loss, and fitness in overweight women: A randomized trial. JAMA 1999;282:1554-
60. 
52. 
Jakicic JM, Marcus BH, Lang W, Janney C. Effect of exercise on 24-month weight loss maintenance in 
overweight women. Archives of Internal Medicine 2008;168:1550-9. 
53. 
Jakicic J, Tate D, Lang W, et al. Dose and pattern of objectively measured physical activity on long-term 
weight loss in adults: Results from the Step-Up Study. Obesity;In Review. 
54. 
Bacon JG, Scheltema KE, Robinson BE. Fat phobia scale revisited: the short form. International Journal of 
Obesity 2001;25:252-7. 
55. 
Lillis J, Luoma JB, Levin ME, Hayes SC. Measuring weight self-stigma: The Weight Self-Stigma 
Questionnaire. Obesity 2010;18:971-6. 
56. 
Durso LE, Latner JD, Ciao AC. Weight bias internalization in treatment-seeking overweight adults: 
Psychometric validation and associations wtih self-esteem, body image, and mood symptoms. Eating Behaviors 
2016;21:104-8. 

16 
Version 1.8 February 2019 
57. 
Lee MS, Dedrick RF. Weight Bias Internalization Scale: Psychometric properties using alternative weight 
status classification. Body Image 2016;17:25-9. 
58. 
Hubner C, Schmidt R, Selle J, et al. Comparing self-report measures of internalized weight stigma: The 
Weight Self-Stigma Questionnaire versus the Weight Bias Internalization Scale. PLos ONE 2016;11:e0165566. 
59. 
Puhl RM, Latner JD, O'Brien K, Luedicke J, Danielsdottir S, Forhan M. A multinational examination of 
weight bias: Predictors of anti-fat attitudes across four countries. International Journal of Obesity 2015;39:1166-73. 
60. 
Sutin AR, Stephan Y, Terracciano A. Weight discrimination and mortality. Psychological Science 2015. 
61. 
Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: Validity and 
reliability of a self-report measure for population health research on racism and health. Social Science & Medicine 
2005;61:1576-96. 
62. 
Puhl RM, Luedicke J. Weight-Based Victimization Among Adolescents in the School Setting: Emotional 
Reactions and Coping Behaviors. Journal of Youth and Adolescence 2012;41:27-40. 
63. 
Williams DR, Yu Y, Jackson JS, Anderson NB. Racial differences in physical and mental health: 
Socioeconomic status, stress, and discrimination. Journal of Health Psychology 1997;2:335-51. 
64. 
Kolotkin RL, Crosby RD, Williams GR. Assessing weight-related quality of life in obese persons with type 
2 diabetes. Diabetes Research and Clinical Practice 2003;61:125-32. 
65. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of Health and Social 
Behavior 1983;24:385-96. 
66. 
Luce KH, Crowther JH. The reliability of the eating disorder examination--Self-report questionnaire 
version (EDE-Q). International Journal of Eating Disorders 1999;25:349-51. 
67. 
Kroenke K, Spitzer RL. The PHQ-9: A new depression diagnostic severity measures. Psychiatric Annals 
2002;32:1-7. 
68. 
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure assessing generalized anxiety disorder: The 
GAD-7. Archives of Internal Medicine 2006;166:1092-7. 
69. 
Brown T, Cash T, Mikulka P. Attitudinal body-image assessment: Factor analysis of the Body-Self 
Relations Questionnaire. Journal of Personality Assessment 1990;55:135-44. 
70. 
Avalos L, Tylka TL, Wood-Barcalow N. The Body Appreciation Scale: Development and psychometric 
evaluation. Body Image 2005;2:285-97. 
71. 
Resnick B, Jenkins L. Testing the reliabilty and validity of the Self-Efficacy for Exercise scale. Nursing 
Research 2000;49:154-9. 
72. 
Clark MM, Abrams DB, Niaura RS, Eaton CA, Rossi JS. Self-efficacy in weight management. Journal of 
Consulting and Clinical Psychology 1991;59:739-44. 
73. 
Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition 
and hunger. Journal of Psychosomatic Research 1985;29:71-83. 
74. 
Craig CL, Marshall AL, Sjostrom M, et al. The International Physical Activity Questionnaire: 12-country 
reliability and validity. Medicine & Science in Sports & Exercise 2003;35:1381-95. 
75. 
Wadden TA, Berkowitz RI, Womble LG, et al. Randomized trial of lifestyle modification and 
pharmacotherapy for obesity. The New England Journal of Medicine 2005;353:2111-20.