A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss

Sponsor
East Carolina University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05987306
Collaborator
University of South Alabama (Other)
60
1
1
9
6.7

Study Details

Study Description

Brief Summary

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12 week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weight loss plus self-compassion
N/A

Detailed Description

The goal of clinical trial is to test a novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises in overweight adults with moderate to high levels of internalized weight bias. The main question[s] it aims to answer are: 1) Can participants lose significant weight loss and 2) significantly reduce internalized weight bias. Participants will take part in a 12-week novel weight loss approach combining a standard weight loss and internalized weight bias intervention with self-compassion exercises using videoconferencing software. The weight loss approach will be modeled after the Diabetes Prevention Program and the approach utilized to reduce internalized weight bias will be Kristen Neff's self-compassion intervention. Each weekly session will utilize Webex videoconferencing software and last approximately 60-90 minutes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group pre and posttest design.Single group pre and posttest design.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

a standard weight loss and internalized weight bias intervention with self-compassion exercises

Behavioral: Weight loss plus self-compassion
A novel weight loss approach combining a standard weight loss based on the Diabetes Prevention Program and internalized weight bias intervention with self-compassion exercises.

Outcome Measures

Primary Outcome Measures

  1. Weight (lbs) [12 weeks]

    Change in weight or percent body weight

  2. Weight Bias Internalization Scale [12 weeks]

    Change in internalized weight bias

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • BMI ≥ 25, ≥ 18 years old, Smartphone access, WBIS score ≥ 4
Exclusion Criteria:
  • Type I diabetes, uncontrolled hypertension, cardiovascular event in past year, any major active kidney, liver, cardio, or cerebrovascular disease, musculoskeletal problems that would prevent physical activity, current weight loss medication or weight loss program, history of bariatric surgery, pregnant or breastfeeding, eating disorder except BED.

Contacts and Locations

Locations

Site City State Country Postal Code
1 East Carolina University Greenville North Carolina United States 27858

Sponsors and Collaborators

  • East Carolina University
  • University of South Alabama

Investigators

  • Principal Investigator: Robert Carels, East Carolina University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
East Carolina University
ClinicalTrials.gov Identifier:
NCT05987306
Other Study ID Numbers:
  • UMCIRB 23-001492
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 14, 2023