Behavioral Weight Loss and Stigma Reduction

Obesity Clinical Trial

Official title:

A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704064
• Other study ID #: 828274, 202002728
• Secondary ID: K23HL140176
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: October 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Stigma-Reduction Intervention
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)
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.

Locations

Country	Name	City	State
United States	The University of Pennsylvania Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Minutes of Sedentary Time at Week 72	Single item from Global Physical Activity Questionnaire (minutes)	Baseline to week 72
Other	Change in Minutes of Sedentary Time at Week 46	Single item from Global Physical Activity Questionnaire (minutes)	Baseline to week 46
Other	Change in Minutes of Sedentary Time at Week 20	Single item from Global Physical Activity Questionnaire (minutes)	Baseline to week 20
Other	Change in High-density Lipoprotein (HDL) Cholesterol at Week 72	Concentration in blood, controlling for medication use	Baseline to week 72
Other	Change in High-density Lipoprotein (HDL) Cholesterol at Week 20	Concentration in blood, controlling for medication use	Baseline to week 20
Other	Change in Waist Circumference at Week 72		Baseline to week 72
Other	Change in Waist Circumference at Week 20		Baseline to week 20
Other	Change in Blood Glucose at Week 72	Concentration in blood, controlling for medication use	Baseline to week 72
Other	Change in Blood Glucose at Week 20	Concentration in blood, controlling for medication use	Baseline to week 20
Other	Change in C-reactive Protein at Week 72	Concentration in blood	Baseline to week 72
Other	Change in C-reactive Protein at Week 20	Concentration in blood	Baseline to week 20
Other	Change in Stereotype Endorsement Scores at Week 72	Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)	Baseline to week 72
Other	Change in Stereotype Endorsement Scores at Week 46	Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)	Baseline to week 46
Other	Change in Stereotype Endorsement Scores at Week 20	Fat Phobia Scale (scores averaged 1-5, with higher scores indicating greater weight bias)	Baseline to week 20
Other	Change in Weight-related Quality of Life at Week 72	Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)	Baseline to week 72
Other	Change in Weight-related Quality of Life at Week 46	Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)	Baseline to week 46
Other	Change in Weight-related Quality of Life at Week 20	Impact of Weight on Quality of Life Questionnaire-Lite (total score and 5 subscales; t-scores ranging from 0-100, with higher scores indicating better quality of life)	Baseline to week 20
Other	Change in Perceived Stress at Week 72	Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)	Baseline to week 72
Other	Change in Perceived Stress at Week 46	Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)	Baseline to week 46
Other	Change in Perceived Stress at Week 20	Perceived Stress Scale (total score 0-40; higher scores = greater perceived stress)	Baseline to week 20
Other	Change in Depression Symptoms at Week 72	Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)	Baseline to week 72
Other	Change in Depression Symptoms at Week 46	Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)	Baseline to week 46
Other	Change in Depression Symptoms at Week 20	Patient Health Questionnaire-9 (scores summed 0-27; higher scores = more symptoms of depression)	Baseline to week 20
Other	Change in Body Image Scores at Week 72	Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)	Baseline to week 72
Other	Change in Body Image Scores at Week 46	Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)	Baseline to week 46
Other	Change in Body Image Scores at Week 20	Body Appreciation Scale (scores averaged 1-5; higher scores = greater body appreciation)	Baseline to week 20
Other	Change in Presence and Frequency of Binge Eating at Week 72	Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)	Baseline to week 72
Other	Change in Presence and Frequency of Binge Eating at Week 46	Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)	Baseline to week 46
Other	Change in Presence and Frequency of Binge Eating at Week 20	Questionnaire on Eating and Weight Patterns (yes/no and episodes per week)	Baseline to week 20
Other	Change in Self-monitoring Behaviors at Week 72	Food records and self-report recording of food intake and physical activity	Baseline to week 72
Other	Change in Self-monitoring Behaviors at Week 46	Food records and self-report recording of food intake and physical activity	Baseline to week 46
Other	Change in Self-monitoring Behaviors at Week 20	Food records and self-report recording of food intake and physical activity	Baseline to week 20
Primary	Percent Weight Change at Week 72	Estimated mean percent change in weight from baseline to week 72	Baseline to week 72
Secondary	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	Baseline to week 72
Secondary	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	Baseline to week 72
Secondary	Percent Weight Change at Week 46	Estimated mean percent weight change	Baseline to week 46
Secondary	Percent Weight Change at Week 20	Estimated mean percent weight change	Baseline to week 20
Secondary	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	Baseline to week 46
Secondary	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	Baseline to week 46
Secondary	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	Baseline to week 20
Secondary	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	Baseline to week 20
Secondary	Change in Minutes of Physical Activity (Accelerometer) at Week 72	Estimated mean change in daily minutes of physical activity, as measured by accelerometry	Baseline to week 72
Secondary	Change in Minutes of Physical Activity (Accelerometer) at Week 46	Estimated mean change in daily minutes of physical activity, as measured by accelerometry	Baseline to week 46
Secondary	Change in Minutes of Physical Activity (Accelerometer) at Week 20	Estimated mean change in daily minutes of physical activity, as measured by accelerometry	Baseline to week 20
Secondary	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.	Baseline to week 72
Secondary	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.	Baseline to week 46
Secondary	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.	Baseline to week 20
Secondary	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)	Baseline to week 72
Secondary	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)	Baseline to week 46
Secondary	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)	Baseline to week 20
Secondary	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)	Baseline to week 72
Secondary	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)	Baseline to week 46
Secondary	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)	Baseline to week 20
Secondary	Change in Triglycerides at Week 72	Estimated mean change in triglyceride concentration in blood	Baseline to week 72
Secondary	Change in Triglycerides at Week 20	Estimated mean change in triglyceride concentration in blood	Baseline to week 20
Secondary	Change in Blood Pressure at Week 72	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)	Baseline to week 72
Secondary	Change in Blood Pressure Week 20	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg)	Baseline to week 20
Secondary	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).	Baseline to week 72
Secondary	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)	Baseline to week 46
Secondary	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)	Baseline to week 20
Secondary	"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)	Baseline to week 72
Secondary	"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)	Baseline to week 46
Secondary	"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)	Baseline to week 20
Secondary	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.	Baseline to week 72
Secondary	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.	Baseline to week 46
Secondary	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.	Baseline to week 20
Secondary	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.	Week 20
Secondary	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.	Week 72