Clinical trial NCT03704064: Behavioral Weight Loss and Stigma Reduction
Official title: A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Weight Stigma
Physical Activity
Cardiovascular Risk Factor
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-10-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Weight Change at Week 72
timeFrame: Baseline to week 72
Secondary outcomes:
measure: Loss of 5% or Greater of Initial Body Weight at Week 72
timeFrame: Baseline to week 72
measure: Loss of 10% or Greater of Initial Body Weight at Week 72
timeFrame: Baseline to week 72
measure: Percent Weight Change at Week 46
timeFrame: Baseline to week 46
measure: Percent Weight Change at Week 20
timeFrame: Baseline to week 20
measure: Loss of 5% or Greater of Initial Body Weight at Week 46
timeFrame: Baseline to week 46
measure: Loss of 10% or Greater of Initial Body Weight at Week 46
timeFrame: Baseline to week 46
measure: Loss of 5% or Greater of Initial Body Weight at Week 20
timeFrame: Baseline to week 20
measure: Loss of 10% or Greater of Initial Body Weight at Week 20
timeFrame: Baseline to week 20
measure: Change in Minutes of Physical Activity (Accelerometer) at Week 72
timeFrame: Baseline to week 72
measure: Change in Minutes of Physical Activity (Accelerometer) at Week 46
timeFrame: Baseline to week 46
measure: Change in Minutes of Physical Activity (Accelerometer) at Week 20
timeFrame: Baseline to week 20
measure: Change in Energy Expenditure at Week 72
timeFrame: Baseline to week 72
measure: Change in Energy Expenditure at Week 46
timeFrame: Baseline to week 46
measure: Change in Energy Expenditure at Week 20
timeFrame: Baseline to week 20
measure: Change in Exercise Self-efficacy at Week 72
timeFrame: Baseline to week 72
measure: Change in Exercise Self-efficacy at Week 46
timeFrame: Baseline to week 46
measure: Change in Exercise Self-efficacy at Week 20
timeFrame: Baseline to week 20
measure: Change in Eating Self-efficacy at Week 72
timeFrame: Baseline to week 72
measure: Change in Eating Self-efficacy at Week 46
timeFrame: Baseline to week 46
measure: Change in Eating Self-efficacy at Week 20
timeFrame: Baseline to week 20
measure: Change in Triglycerides at Week 72
timeFrame: Baseline to week 72
measure: Change in Triglycerides at Week 20
timeFrame: Baseline to week 20
measure: Change in Blood Pressure at Week 72
timeFrame: Baseline to week 72
measure: Change in Blood Pressure Week 20
timeFrame: Baseline to week 20
measure: Change in Weight Bias Internalization Scale Score at Week 72
timeFrame: Baseline to week 72
measure: Change in Weight Bias Internalization Scale Score at Week 46
timeFrame: Baseline to week 46
measure: Change in Weight Bias Internalization Scale Score at Week 20
timeFrame: Baseline to week 20
measure: "Remission" of Elevated Weight Bias Internalization at Week 72
timeFrame: Baseline to week 72
measure: "Remission" of Elevated Weight Bias Internalization at Week 46
timeFrame: Baseline to week 46
measure: "Remission" of Elevated Weight Bias Internalization at Week 20
timeFrame: Baseline to week 20
measure: Change in Weight Self-stigma Scores at Week 72
timeFrame: Baseline to week 72
measure: Change in Weight Self-stigma Scores at Week 46
timeFrame: Baseline to week 46
measure: Change in Weight Self-stigma Scores at Week 20
timeFrame: Baseline to week 20
measure: Treatment Acceptability at Week 20
timeFrame: Week 20
measure: Treatment Acceptability at Week 72
timeFrame: Week 72
Other outcomes:
measure: Change in Minutes of Sedentary Time at Week 72
timeFrame: Baseline to week 72
measure: Change in Minutes of Sedentary Time at Week 46
timeFrame: Baseline to week 46
measure: Change in Minutes of Sedentary Time at Week 20
timeFrame: Baseline to week 20
measure: Change in High-density Lipoprotein (HDL) Cholesterol at Week 72
timeFrame: Baseline to week 72
measure: Change in High-density Lipoprotein (HDL) Cholesterol at Week 20
timeFrame: Baseline to week 20
measure: Change in Waist Circumference at Week 72
timeFrame: Baseline to week 72
measure: Change in Waist Circumference at Week 20
timeFrame: Baseline to week 20
measure: Change in Blood Glucose at Week 72
timeFrame: Baseline to week 72
measure: Change in Blood Glucose at Week 20
timeFrame: Baseline to week 20
measure: Change in C-reactive Protein at Week 72
timeFrame: Baseline to week 72
measure: Change in C-reactive Protein at Week 20
timeFrame: Baseline to week 20
measure: Change in Stereotype Endorsement Scores at Week 72
timeFrame: Baseline to week 72
measure: Change in Stereotype Endorsement Scores at Week 46
timeFrame: Baseline to week 46
measure: Change in Stereotype Endorsement Scores at Week 20
timeFrame: Baseline to week 20
measure: Change in Weight-related Quality of Life at Week 72
timeFrame: Baseline to week 72
measure: Change in Weight-related Quality of Life at Week 46
timeFrame: Baseline to week 46
measure: Change in Weight-related Quality of Life at Week 20
timeFrame: Baseline to week 20
measure: Change in Perceived Stress at Week 72
timeFrame: Baseline to week 72
measure: Change in Perceived Stress at Week 46
timeFrame: Baseline to week 46
measure: Change in Perceived Stress at Week 20
timeFrame: Baseline to week 20
measure: Change in Depression Symptoms at Week 72
timeFrame: Baseline to week 72
measure: Change in Depression Symptoms at Week 46
timeFrame: Baseline to week 46
measure: Change in Depression Symptoms at Week 20
timeFrame: Baseline to week 20
measure: Change in Body Image Scores at Week 72
timeFrame: Baseline to week 72
measure: Change in Body Image Scores at Week 46
timeFrame: Baseline to week 46
measure: Change in Body Image Scores at Week 20
timeFrame: Baseline to week 20
measure: Change in Presence and Frequency of Binge Eating at Week 72
timeFrame: Baseline to week 72
measure: Change in Presence and Frequency of Binge Eating at Week 46
timeFrame: Baseline to week 46
measure: Change in Presence and Frequency of Binge Eating at Week 20
timeFrame: Baseline to week 20
measure: Change in Self-monitoring Behaviors at Week 72
timeFrame: Baseline to week 72
measure: Change in Self-monitoring Behaviors at Week 46
timeFrame: Baseline to week 46
measure: Change in Self-monitoring Behaviors at Week 20
timeFrame: Baseline to week 20
Locations:
city: Philadelphia
country: United States
facility: The University of Pennsylvania Center for Weight and Eating Disorders
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Rebecca L Pearl, PhD
role: PRINCIPAL_INVESTIGATOR
References: