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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Weight loss plus self-compassion

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Carels; Phone Number: 4193782704; Email: carelsr14@ecu.edu
• Study Contact Backup: Name: Abbie Metzler

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • Not yet recruiting
      • East Carolina University
      • Contact: Robert Carels, PhD; Phone Number: 252-737-5070; Email: carelsr14@ecu.edu
      • Contact: Abbie Metzler, BA; Phone Number: 2527375070; Email: metzlera23@students.ecu.edu
    • Greenville, North Carolina, United States, 27858
      • Recruiting
      • ECU, Dept of Psychology, 104 Rawl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: East Carolina University
• Collaborators: University of South Alabama
• Investigators: Principal Investigator: Robert Carels, East Carolina University

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: UMCIRB 23-001492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I am happy to make data available to qualified researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No