Behavioral Weight Loss and Stigma Reduction

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Stigma-Reduction Intervention; Behavioral: Behavioral Weight Loss (BWL)

• Registration Number: NCT03704064
• Lead Sponsor: University of Pennsylvania

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-12
• Study Start: 2018-10-16
• Primary Completion: 2021-07-26
• Study Completion: 2021-08-02
• Results First Submitted: 2022-08-11
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-03
• Results First Posted: 2022-10-31
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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.

  o 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.

• 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

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Exclusion Criteria

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).

  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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stigma + BWL Intervention	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	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.
Stigma + BWL Intervention	Stigma-Reduction Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percent Weight Change at Week 72	Baseline to week 72	Estimated mean percent change in weight from baseline to week 72

Secondary Outcome Measures

Name	Time	Method
Loss of 10% or Greater of Initial Body Weight at Week 72	Baseline to week 72	The percentage of participants who lost 10% or greater of their initial body weight at week 72
Percent Weight Change at Week 20	Baseline to week 20	Estimated mean percent weight change
Loss of 10% or Greater of Initial Body Weight at Week 46	Baseline to week 46	The percentage of participants who lost 10% or greater of their initial body weight at week 46
Loss of 5% or Greater of Initial Body Weight at Week 20	Baseline to week 20	The percentage of participants who lost 5% or greater of their initial body weight at week 20
Change in Minutes of Physical Activity (Accelerometer) at Week 20	Baseline to week 20	Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Change in Energy Expenditure at Week 20	Baseline to week 20	Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Loss of 5% or Greater of Initial Body Weight at Week 46	Baseline to week 46	The percentage of participants who lost 5% or greater of their initial body weight at week 46
Change in Minutes of Physical Activity (Accelerometer) at Week 46	Baseline to week 46	Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Change in Eating Self-efficacy at Week 20	Baseline to week 20	Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Change in Blood Pressure Week 20	Baseline to week 20	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
"Remission" of Elevated Weight Bias Internalization at Week 46	Baseline to 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)
"Remission" of Elevated Weight Bias Internalization at Week 20	Baseline to 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)
Change in Eating Self-efficacy at Week 46	Baseline to week 46	Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Change in Triglycerides at Week 20	Baseline to week 20	Estimated mean change in triglyceride concentration in blood
Change in Blood Pressure at Week 72	Baseline to week 72	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)
Change in Weight Bias Internalization Scale Score at Week 46	Baseline to week 46	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Treatment Acceptability at Week 72	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.
Loss of 5% or Greater of Initial Body Weight at Week 72	Baseline to week 72	The percentage of participants who lost 5% or greater of their initial body weight at week 72
Change in Energy Expenditure at Week 72	Baseline to week 72	Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Change in Eating Self-efficacy at Week 72	Baseline to week 72	Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy)
Change in Triglycerides at Week 72	Baseline to week 72	Estimated mean change in triglyceride concentration in blood
Change in Weight Self-stigma Scores at Week 72	Baseline to 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.
Change in Weight Self-stigma Scores at Week 46	Baseline to 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.
Treatment Acceptability at Week 20	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.
Percent Weight Change at Week 46	Baseline to week 46	Estimated mean percent weight change
Loss of 10% or Greater of Initial Body Weight at Week 20	Baseline to week 20	The percentage of participants who lost 10% or greater of their initial body weight at week 20
Change in Minutes of Physical Activity (Accelerometer) at Week 72	Baseline to week 72	Estimated mean change in daily minutes of physical activity, as measured by accelerometry
Change in Energy Expenditure at Week 46	Baseline to week 46	Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure.
Change in Weight Self-stigma Scores at Week 20	Baseline to 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.
Change in Exercise Self-efficacy at Week 72	Baseline to week 72	Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Change in Exercise Self-efficacy at Week 46	Baseline to week 46	Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Change in Exercise Self-efficacy at Week 20	Baseline to week 20	Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy)
Change in Weight Bias Internalization Scale Score at Week 72	Baseline to week 72	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization).
Change in Weight Bias Internalization Scale Score at Week 20	Baseline to week 20	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
"Remission" of Elevated Weight Bias Internalization at Week 72	Baseline to 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)

Trial Locations

Locations (1)

The University of Pennsylvania Center for Weight and Eating Disorders; 🇺🇸 Philadelphia, Pennsylvania, United States