Behavioral Weight Loss and Stigma Reduction
NCT03704064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2022-11-02
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.
Conditions
Interventions
- 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
-
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.
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH - lead OTHER
Principal Investigators
-
Rebecca L Pearl, PhD · University of Pennsylvania
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-16
- Primary Completion
- 2021-07-26
- Completion
- 2021-08-02
Countries
- United States
Study Locations
More Related Trials
-
Behavioral Weight Loss and Sleep Health Intervention
NCT07255287 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Increasing Uptake of Behavioral Weight Loss Programs Among Primary Care Patients
NCT02708121 ·Status: COMPLETED ·Phase: NA
-
Study of a Personalized vs. Standard Approach to Weight Loss Recommendations
NCT04639076 ·Status: COMPLETED ·Phase: NA
-
Acceptance Based Behavioral Intervention for Weight Loss: A Randomized Trial
NCT01461421 ·Status: COMPLETED ·Phase: NA
-
Use of Medication to Improve Weight Loss in Suboptimal Early Responders to Behavioral Treatment
NCT03779048 ·Status: COMPLETED ·Phase: PHASE4
-
Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open Trial
NCT06389656 ·Status: COMPLETED ·Phase: NA
-
A Study to Investigate Why Overweight People Regain Weight After Losing Weight in a Behavioral Weight Loss Program
NCT05748158 ·Status: RECRUITING ·Phase: NA
-
Exercise Adherence in a Behavioral Weight Loss Program
NCT00005743 ·Status: COMPLETED ·Phase: NA
-
FAMily-centered WEight Loss for Black Adults (FAM WEL B-ing)
NCT06724406 ·Status: RECRUITING ·Phase: NA
-
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms
NCT01854320 ·Status: COMPLETED ·Phase: NA
-
Improving Self-Monitoring in Weight Loss With Technology
NCT00277771 ·Status: COMPLETED ·Phase: NA
-
Evaluating the Effectiveness of Financial Incentives in Promoting Weight Loss Among Obese Individuals.
NCT00520611 ·Status: COMPLETED ·Phase: NA
-
Peer-Led Healthy Lifestyle Program in Supportive Housing
NCT02175641 ·Status: COMPLETED ·Phase: NA
-
Does Motivational Interviewing Improve Behavioral Weight Loss Outcomes for Obesity?
NCT02649634 ·Status: COMPLETED ·Phase: NA
-
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
NCT00827593 ·Status: COMPLETED ·Phase: NA
-
Brief Behavioral Weight Loss Treatment vs. Weight Watchers
NCT00249340 ·Status: COMPLETED ·Phase: NA
-
Maintenance-Tailored Obesity Treatment
NCT00670462 ·Status: COMPLETED ·Phase: NA
-
Weight Management Skills in African American Outpatients
NCT00146081 ·Status: COMPLETED ·Phase: NA
-
Behavioral Strategies for Weight Management
NCT00575731 ·Status: COMPLETED ·Phase: NA
-
Engaging Motivation for the Prevention of Weight Regain
NCT01169428 ·Status: COMPLETED ·Phase: PHASE2
-
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
NCT00533052 ·Status: COMPLETED ·Phase: NA
-
Prevention & Promotion in the Treatment of Obesity
NCT02990494 ·Status: COMPLETED ·Phase: NA
-
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
NCT02156752 ·Status: COMPLETED ·Phase: NA
-
FoodRx for Obesity Treatment
NCT05635019 ·Status: COMPLETED ·Phase: NA
-
SMART 2.0: Social Mobile Approaches to Reducing weighT in Young Adults
NCT03907462 ·Status: COMPLETED ·Phase: NA