ObesityNCT03704064
Behavioral Weight Loss and Stigma Reduction
A study testing Stigma-Reduction Intervention and Behavioral Weight Loss (BWL) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Stigma-Reduction Intervention and Behavioral Weight Loss (BWL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 2 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants will be men and women ages 18 years and older.
- Participants must have obesity, defined as a BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with an obesity-related comorbidity.
- o Obesity-related comorbidities (which confer added CVD risk) will include:
- coronary heart disease;
- other atherosclerotic disease;
- sleep apnea;
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- hypercholesteremia (i.e., high cholesterol, as diagnosed by doctor and/or if taking medication to lower cholesterol);
- and components of the metabolic syndrome, including hypertension (SBP ≥130, DBP ≥80 mm Hg, diagnosed by doctor and/or if taking anti-hypertensive medication); fasting blood glucose of 100-125 mg/dL (or prediabetes, diagnosed by doctor),; low HDL cholesterol (<40 mg/dL in men, <50 mg/dL in women), elevated triglycerides (>150 mg/dL, i.e., dyslipidemia diagnosed by doctor or taking medication to treat dyslipidemia), or elevated waist circumference (≥40 in for men, ≥35 in for women),.
- Eligible participants must also report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview, and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview.
- Participants must be seeking weight loss.
- If currently taking medications, dosages must be stable for at least 3 months.
- Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables.
- Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months.
- Eligible female patients will be:
- non-pregnant and non-lactating
- surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study
- Participants must:
- have a PCP who is responsible for providing routine care
- have reliable telephone service and/or email access with which to be in contact with the study team
- understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent
Who cannot join
- 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).
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- o Participants who have recently received or are currently receiving therapy for a pre-existing mental health issue unrelated to weight (e.g., psychotherapy for depression or anxiety, or marriage, grief, or career counseling) may be eligible if the therapy is deemed by the Principal Investigator to be unlikely to affect weight, eating habits, or physical activity.
- Applicants with severe symptoms of mood (BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program.
- o Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.
- Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.
- Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.
- Applicants will not be eligible if they have a history of bariatric surgery.
- Women who are nursing, pregnant, or planning to become pregnant in the next 16 months are not eligible to participate.
- Applicants who report obtaining 150 minutes or more of structured physical activity per week (e.g., 30 minutes 5 days per week) will not be eligible, as they will already be obtaining the recommended amount of physical activity and may not be able to further increase their activity as part of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.
- Conditions
- Obesity
- Being tested
- Stigma-Reduction Intervention, Behavioral Weight Loss (BWL)
- Keywords
- Weight Loss, Weight Stigma, Physical Activity, Cardiovascular Risk Factor
- Medical subject headings
- Obesity, Weight Loss, Weight Prejudice, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stigma-Reduction InterventionBehavioural
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.
Behavioral Weight Loss (BWL)Behavioural
This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.
| Study group | Role | What they receive |
|---|---|---|
| Stigma + BWL Intervention | Experimental | Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity. Receives: Behavioral: Stigma-Reduction Intervention; Behavioral: Behavioral Weight Loss (BWL) |
| Standard BWL Intervention | Active comparator | Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation. Receives: Behavioral: Behavioral Weight Loss (BWL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Weight Change at Week 72
Estimated mean percent change in weight from baseline to week 72
Measured: Baseline to week 72
Secondary outcomes (35)
Loss of 5% or Greater of Initial Body Weight at Week 72
The percentage of participants who lost 5% or greater of their initial body weight at week 72
Measured: Baseline to week 72
Loss of 10% or Greater of Initial Body Weight at Week 72
The percentage of participants who lost 10% or greater of their initial body weight at week 72
Measured: Baseline to week 72
Percent Weight Change at Week 46
Estimated mean percent weight change
Measured: Baseline to week 46
Percent Weight Change at Week 20
Estimated mean percent weight change
Measured: Baseline to week 20
Loss of 5% or Greater of Initial Body Weight at Week 46
The percentage of participants who lost 5% or greater of their initial body weight at week 46
Measured: Baseline to week 46
Loss of 10% or Greater of Initial Body Weight at Week 46
The percentage of participants who lost 10% or greater of their initial body weight at week 46
Measured: Baseline to week 46
Loss of 5% or Greater of Initial Body Weight at Week 20
The percentage of participants who lost 5% or greater of their initial body weight at week 20
Measured: Baseline to week 20
Loss of 10% or Greater of Initial Body Weight at Week 20
The percentage of participants who lost 10% or greater of their initial body weight at week 20
Measured: Baseline to week 20
Change in Minutes of Physical Activity (Accelerometer) at Week 72
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Measured: Baseline to week 72
Change in Minutes of Physical Activity (Accelerometer) at Week 46
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Measured: Baseline to week 46
Change in Minutes of Physical Activity (Accelerometer) at Week 20
Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Measured: Baseline to week 20
Change in Energy Expenditure at Week 72
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Measured: Baseline to week 72
Change in Energy Expenditure at Week 46
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Measured: Baseline to week 46
Change in Energy Expenditure at Week 20
Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Measured: Baseline to week 20
Change in Exercise Self-efficacy at Week 72
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Measured: Baseline to week 72
Change in Exercise Self-efficacy at Week 46
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Measured: Baseline to week 46
Change in Exercise Self-efficacy at Week 20
Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Measured: Baseline to week 20
Change in Eating Self-efficacy at Week 72
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Measured: Baseline to week 72
Change in Eating Self-efficacy at Week 46
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Measured: Baseline to week 46
Change in Eating Self-efficacy at Week 20
Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Measured: Baseline to week 20
Change in Triglycerides at Week 72
Estimated mean change in triglyceride concentration in blood
Measured: Baseline to week 72
Change in Triglycerides at Week 20
Estimated mean change in triglyceride concentration in blood
Measured: Baseline to week 20
Change in Blood Pressure at Week 72
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Measured: Baseline to week 72
Change in Blood Pressure Week 20
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Measured: Baseline to week 20
Change in Weight Bias Internalization Scale Score at Week 72
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization).
Measured: Baseline to week 72
Change in Weight Bias Internalization Scale Score at Week 46
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 46
Change in Weight Bias Internalization Scale Score at Week 20
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 20
"Remission" of Elevated Weight Bias Internalization at Week 72
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 72
"Remission" of Elevated Weight Bias Internalization at Week 46
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 46
"Remission" of Elevated Weight Bias Internalization at Week 20
Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Measured: Baseline to week 20
Change in Weight Self-stigma Scores at Week 72
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Measured: Baseline to week 72
Change in Weight Self-stigma Scores at Week 46
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Measured: Baseline to week 46
Change in Weight Self-stigma Scores at Week 20
Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma.
Measured: Baseline to week 20
Treatment Acceptability at Week 20
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Measured: Week 20
Treatment Acceptability at Week 72
To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability.
Measured: Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start16 Oct 2018
- Primary completion26 Jul 2021
- Study completion2 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Rebecca L. Pearl, Ph.D., University of Pennsylvania
- Investigators
- Rebecca L Pearl, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704064
- Sponsor's protocol ID
- 828274, 202002728
- Other IDs
- K23HL140176
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2018
- Last updated
- 2 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheynblyum M, Wadden TA, Latner JD, Pearl RL. Longitudinal associations of internalized weight stigma with physical activity and weight loss. Obes Sci Pract. 2024 Jul 3;10(4):e773. doi: 10.1002/osp4.773. eCollection 2024 Aug.
PubMed 38966255Pearl RL, Wadden TA, Bach C, LaFata EM, Gautam S, Leonard S, Berkowitz RI, Latner JD, Jakicic JM. Long-term effects of an internalized weight stigma intervention: A randomized controlled trial. J Consult Clin Psychol. 2023 Jul;91(7):398-410. doi: 10.1037/ccp0000819. Epub 2023 May 8.
PubMed 37155264
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss
- ClinicalTrials.gov ID
- NCT03704064
- Acronym / sponsor ID
- 828274, 202002728
- Conditions
- Obesity
- Keywords
- Weight Loss, Weight Stigma, Physical Activity, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 2 Aug 2021 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 31 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stigma + BWL Intervention | Experimental | Behavioral: Stigma-Reduction Intervention, Behavioral: Behavioral Weight Loss (BWL)Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity. |
| Standard BWL Intervention | Active comparator | Behavioral: Behavioral Weight Loss (BWL)Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
- coronary heart disease;
- other atherosclerotic disease;
- sleep apnea;
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stigma-Reduction InterventionSession 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. | Behavioural | Stigma + BWL Intervention |
| Behavioral Weight Loss (BWL)This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity. | Behavioural | Standard BWL Intervention, Stigma + BWL Intervention |
Primary outcome
Percent Weight Change at Week 72
Time frame: Baseline to week 72
Estimated mean percent change in weight from baseline to week 72
35 secondary outcomes
Loss of 5% or Greater of Initial Body Weight at Week 72
Time frame: Baseline to week 72
Loss of 10% or Greater of Initial Body Weight at Week 72
Time frame: Baseline to week 72
Percent Weight Change at Week 46
Time frame: Baseline to week 46
Percent Weight Change at Week 20
Time frame: Baseline to week 20
Loss of 5% or Greater of Initial Body Weight at Week 46
Time frame: Baseline to week 46
Loss of 10% or Greater of Initial Body Weight at Week 46
Time frame: Baseline to week 46
Loss of 5% or Greater of Initial Body Weight at Week 20
Time frame: Baseline to week 20
Loss of 10% or Greater of Initial Body Weight at Week 20
Time frame: Baseline to week 20
Change in Minutes of Physical Activity (Accelerometer) at Week 72
Time frame: Baseline to week 72
Change in Minutes of Physical Activity (Accelerometer) at Week 46
Time frame: Baseline to week 46
Change in Minutes of Physical Activity (Accelerometer) at Week 20
Time frame: Baseline to week 20
Change in Energy Expenditure at Week 72
Time frame: Baseline to week 72
Change in Energy Expenditure at Week 46
Time frame: Baseline to week 46
Change in Energy Expenditure at Week 20
Time frame: Baseline to week 20
Change in Exercise Self-efficacy at Week 72
Time frame: Baseline to week 72
Change in Exercise Self-efficacy at Week 46
Time frame: Baseline to week 46
Change in Exercise Self-efficacy at Week 20
Time frame: Baseline to week 20
Change in Eating Self-efficacy at Week 72
Time frame: Baseline to week 72
Change in Eating Self-efficacy at Week 46
Time frame: Baseline to week 46
Change in Eating Self-efficacy at Week 20
Time frame: Baseline to week 20
Change in Triglycerides at Week 72
Time frame: Baseline to week 72
Change in Triglycerides at Week 20
Time frame: Baseline to week 20
Change in Blood Pressure at Week 72
Time frame: Baseline to week 72
Change in Blood Pressure Week 20
Time frame: Baseline to week 20
Change in Weight Bias Internalization Scale Score at Week 72
Time frame: Baseline to week 72
Change in Weight Bias Internalization Scale Score at Week 46
Time frame: Baseline to week 46
Change in Weight Bias Internalization Scale Score at Week 20
Time frame: Baseline to week 20
"Remission" of Elevated Weight Bias Internalization at Week 72
Time frame: Baseline to week 72
"Remission" of Elevated Weight Bias Internalization at Week 46
Time frame: Baseline to week 46
"Remission" of Elevated Weight Bias Internalization at Week 20
Time frame: Baseline to week 20
Change in Weight Self-stigma Scores at Week 72
Time frame: Baseline to week 72
Change in Weight Self-stigma Scores at Week 46
Time frame: Baseline to week 46
Change in Weight Self-stigma Scores at Week 20
Time frame: Baseline to week 20
Treatment Acceptability at Week 20
Time frame: Week 20
Treatment Acceptability at Week 72
Time frame: Week 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38966255Sheynblyum M, Wadden TA, Latner JD, Pearl RL. Longitudinal associations of internalized weight stigma with physical activity and weight loss. Obes Sci Pract. 2024 Jul 3;10(4):e773. doi: 10.1002/osp4.773. eCollection 2024 Aug.
- Derived from this study: PubMed 37155264Pearl RL, Wadden TA, Bach C, LaFata EM, Gautam S, Leonard S, Berkowitz RI, Latner JD, Jakicic JM. Long-term effects of an internalized weight stigma intervention: A randomized controlled trial. J Consult Clin Psychol. 2023 Jul;91(7):398-410. doi: 10.1037/ccp0000819. Epub 2023 May 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca L Pearl, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stigma-Reduction Intervention and Behavioral Weight Loss (BWL) in people with Obesity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Weight Change at Week 72 (time frame: Baseline to week 72). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704064, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.