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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987306
• Other study ID #: UMCIRB 23-001492
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: November 2023
• Source: East Carolina University
• Contact: Robert Carels
• Phone: 4193782704
• Email: carelsr14[@]ecu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 binge eating disorder

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	East Carolina University	Greenville	North Carolina
United States	ECU, Dept of Psychology, 104 Rawl	Greenville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
East Carolina University	University of South Alabama

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight (lbs)	Change in weight or percent body weight	12 weeks
Primary	Weight Bias Internalization Scale	Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)	12 weeks