Psychological Intervention to Reduce Weight Bias Internalization

Obesity Clinical Trial

Official title:

A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572218
• Other study ID #: 829070
• Status: Completed
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: October 18, 2019

Study information

• Verified date: September 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 18, 2019
• Est. primary completion date: April 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Stigmatization
• Weight Loss

Intervention

Behavioral:
• BWL
The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. 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 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.
• BIAS
Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: 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 weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.

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	Weight Watchers International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Coping Behaviors in Response to Weight Stigma	Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies	Baseline to week 12
Other	Coping Behaviors in Response to Weight Stigma	Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies	Baseline to week 26
Other	Body Esteem	Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)	Baseline to Week 12
Other	Body Esteem	Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)	Baseline to Week 26
Other	Body Dissatisfaction	Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)	Baseline to Week 12
Other	Body Dissatisfaction	Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)	Baseline to Week 26
Other	Disordered Eating	Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)	Baseline to Week 12
Other	Disordered Eating	Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)	Baseline to Week 26
Other	Eating Behaviors	Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger	Baseline to Week 12
Other	Eating Behaviors	Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger	Baseline to Week 26
Other	Anxiety	Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)	Baseline to Week 12
Other	Anxiety	Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)	Baseline to Week 26
Other	Dietary Monitoring	Estimated mean change in number of days recording caloric intake	Baseline to Week 12
Other	Dietary Monitoring	Estimated mean change in number of days recording caloric intake	Baseline to Week 26
Other	Self-Reported Self-Monitoring Behaviors	Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)	Baseline to Week 12
Other	Self-Reported Self-Monitoring Behaviors	Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)	Baseline to Week 26
Other	Weight Bias Internalization	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)	Baseline to week 52
Other	Weight Self-Stigma Questionnaire (WSSQ)	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-FNE) (summed 6-30); higher scores indicate greater weight self-stigma	Baseline to week 52
Other	Weight Bias	Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)	Baseline to week 52
Other	Depression	Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)	Baseline to week 52
Other	Perceived Stress	Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)	Baseline to week 52
Other	Exercise Self-Efficacy	Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)	Baseline to week 52
Other	Weight-Related Quality of Life	Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)	Baseline to week 52
Other	Eating Self-Efficacy	Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)	Baseline to week 52
Other	Percent Weight Change	Estimated mean change in percent weight change. Weight measured in kilograms (kg)	Baseline to week 52
Other	Waist Circumference	Estimated mean change in waist circumference (cm)	Baseline to week 52
Other	Blood Pressure	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.	Baseline to week 52
Other	Body Esteem	Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)	Baseline to Week 52
Other	Coping Behaviors in Response to Weight Stigma	Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies	Baseline to Week 52
Other	Body Dissatisfaction	Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)	Baseline to Week 52
Other	Anxiety	Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)	Baseline to Week 52
Other	Disordered Eating	Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)	Baseline to Week 52
Other	Eating Behaviors	Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger	Baseline to Week 52
Other	Self-Reported Self-Monitoring Behaviors	Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)	Baseline to Week 52
Other	Treatment Acceptability Ratings	To assess treatment acceptability, participants in both groups 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 new skills or information from each component. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Higher scores indicate greater treatment acceptability.	Week 26
Other	Treatment Acceptability Ratings	To assess treatment acceptability, participants rated (1-7) 5 items to indicate the extent to which they found the program (as a whole) to be helpful and acceptable, and how much they liked, were satisfied with, and would recommend the program to others. Scores are averaged 1-7, with higher scores indicating greater treatment acceptability.	Week 52
Primary	Weight Bias Internalization	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)	Baseline to week 12
Secondary	Weight Bias Internalization	Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)	Baseline to week 26
Secondary	Weight Self-Stigma Questionnaire (WSSQ)	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-FNE) (summed 6-30); higher scores indicate greater weight self-stigma	Baseline to week 12
Secondary	Weight Self-Stigma Questionnaire (WSSQ)	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-FNE) (summed 6-30); higher scores indicate greater weight self-stigma	Baseline to week 26
Secondary	Weight Bias	Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)	Baseline to week 12
Secondary	Weight Bias	Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)	Baseline to week 26
Secondary	Weight-Related Quality of Life	Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)	Baseline to week 12
Secondary	Weight-Related Quality of Life	Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life)	Baseline to week 26
Secondary	Perceived Stress	Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)	Baseline to week 12
Secondary	Perceived Stress	Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)	Baseline to week 26
Secondary	Depression	Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)	Baseline to week 12
Secondary	Depression	Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)	Baseline to week 26
Secondary	Exercise Self-Efficacy	Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)	Baseline to week 12
Secondary	Exercise Self-Efficacy	Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)	Baseline to week 26
Secondary	Eating Self-Efficacy	Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)	Baseline to week 12
Secondary	Eating Self-Efficacy	Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)	Baseline to week 26
Secondary	Percent Weight Change	Estimated mean change in percent weight change. Weight measured in kilograms (kg).	Baseline to week 26
Secondary	Waist Circumference	Estimated mean change in waist circumference (cm).	Baseline to week 26
Secondary	Blood Pressure	Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.	Baseline to week 26