Clinical trial NCT03572218: Psychological Intervention to Reduce Weight Bias Internalization
Official title: A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigmatization
Obesity
Weight Loss
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2018-06-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.


Eligibility criteria: Inclusion Criteria:

* Eligible participants will be men and women ages 18-65 years.
* Participants must have obesity (defined as a BMI ≥ 30 kg/m2); report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview; and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) 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, evidenced by a negative urine dipstick pregnancy test
* non-lactating
* surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study

Participants must:

* have a PCP who is responsible for providing routine care
* have reliable telephone service with which to participate in conference calls
* understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent

Exclusion Criteria:

Applicants will be excluded if they have:

* a diagnosis of type I or II diabetes;
* uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg);
* experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months;
* lost ≥ 5% of their initial weight in the last 6 months;
* or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion.
* Applicants with severe symptoms of mood (for example, BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion.
* Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated.
* Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area.
* Applicants will not be eligible if they have a history of bariatric surgery.
* Women who are nursing, pregnant, or planning to become pregnant in the next 12 months are not eligible to participate.

Primary outcomes:
measure: Weight Bias Internalization
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Weight Bias Internalization
timeFrame: Baseline to week 26
measure: Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Baseline to week 12
measure: Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Baseline to week 26
measure: Weight Bias
timeFrame: Baseline to week 12
measure: Weight Bias
timeFrame: Baseline to week 26
measure: Weight-Related Quality of Life
timeFrame: Baseline to week 12
measure: Weight-Related Quality of Life
timeFrame: Baseline to week 26
measure: Perceived Stress
timeFrame: Baseline to week 12
measure: Perceived Stress
timeFrame: Baseline to week 26
measure: Depression
timeFrame: Baseline to week 12
measure: Depression
timeFrame: Baseline to week 26
measure: Exercise Self-Efficacy
timeFrame: Baseline to week 12
measure: Exercise Self-Efficacy
timeFrame: Baseline to week 26
measure: Eating Self-Efficacy
timeFrame: Baseline to week 12
measure: Eating Self-Efficacy
timeFrame: Baseline to week 26
measure: Percent Weight Change
timeFrame: Baseline to week 26
measure: Waist Circumference
timeFrame: Baseline to week 26
measure: Blood Pressure
timeFrame: Baseline to week 26
Other outcomes:
measure: Coping Behaviors in Response to Weight Stigma
timeFrame: Baseline to week 12
measure: Coping Behaviors in Response to Weight Stigma
timeFrame: Baseline to week 26
measure: Body Esteem
timeFrame: Baseline to Week 12
measure: Body Esteem
timeFrame: Baseline to Week 26
measure: Body Dissatisfaction
timeFrame: Baseline to Week 12
measure: Body Dissatisfaction
timeFrame: Baseline to Week 26
measure: Disordered Eating
timeFrame: Baseline to Week 12
measure: Disordered Eating
timeFrame: Baseline to Week 26
measure: Eating Behaviors
timeFrame: Baseline to Week 12
measure: Eating Behaviors
timeFrame: Baseline to Week 26
measure: Anxiety
timeFrame: Baseline to Week 12
measure: Anxiety
timeFrame: Baseline to Week 26
measure: Dietary Monitoring
timeFrame: Baseline to Week 12
measure: Dietary Monitoring
timeFrame: Baseline to Week 26
measure: Self-Reported Self-Monitoring Behaviors
timeFrame: Baseline to Week 12
measure: Self-Reported Self-Monitoring Behaviors
timeFrame: Baseline to Week 26
measure: Weight Bias Internalization
timeFrame: Baseline to week 52
measure: Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Baseline to week 52
measure: Weight Bias
timeFrame: Baseline to week 52
measure: Depression
timeFrame: Baseline to week 52
measure: Perceived Stress
timeFrame: Baseline to week 52
measure: Exercise Self-Efficacy
timeFrame: Baseline to week 52
measure: Weight-Related Quality of Life
timeFrame: Baseline to week 52
measure: Eating Self-Efficacy
timeFrame: Baseline to week 52
measure: Percent Weight Change
timeFrame: Baseline to week 52
measure: Waist Circumference
timeFrame: Baseline to week 52
measure: Blood Pressure
timeFrame: Baseline to week 52
measure: Body Esteem
timeFrame: Baseline to Week 52
measure: Coping Behaviors in Response to Weight Stigma
timeFrame: Baseline to Week 52
measure: Body Dissatisfaction
timeFrame: Baseline to Week 52
measure: Anxiety
timeFrame: Baseline to Week 52
measure: Disordered Eating
timeFrame: Baseline to Week 52
measure: Eating Behaviors
timeFrame: Baseline to Week 52
measure: Self-Reported Self-Monitoring Behaviors
timeFrame: Baseline to Week 52
measure: Treatment Acceptability Ratings
timeFrame: Week 26
measure: Treatment Acceptability Ratings
timeFrame: Week 52
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:
citation: Pearl RL, Wadden TA, Bach C, Tronieri JS, Berkowitz RI. Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program. Obesity (Silver Spring). 2020 Oct;28(10):1878-1888. doi: 10.1002/oby.22931. Epub 2020 Aug 28.