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

Primary Purpose

Overweight and Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight loss plus self-compassion
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • East Carolina University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

Weight (lbs)
Change in weight or percent body weight
Weight Bias Internalization Scale
Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)

Secondary Outcome Measures

Full Information

First Posted
July 25, 2023
Last Updated
September 22, 2023
Sponsor
East Carolina University
Collaborators
University of South Alabama
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1. Study Identification

Unique Protocol Identification Number
NCT05987306
Brief Title
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
Official Title
A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 24, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Carolina University
Collaborators
University of South Alabama

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre and posttest design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
a standard weight loss and internalized weight bias intervention with self-compassion exercises
Intervention Type
Behavioral
Intervention Name(s)
Weight loss plus self-compassion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight (lbs)
Description
Change in weight or percent body weight
Time Frame
12 weeks
Title
Weight Bias Internalization Scale
Description
Change in internalized weight bias (range 1-7 with higher scores indicating greater internalized weight bias)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Carels
Phone
4193782704
Email
carelsr14@ecu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Abbie Metzler
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Carels
Organizational Affiliation
East Carolina University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Carels, PhD
Phone
252-737-5070
Email
carelsr14@ecu.edu
First Name & Middle Initial & Last Name & Degree
Abbie Metzler, BA
Phone
2527375070
Email
metzlera23@students.ecu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
I am happy to make data available to qualified researchers.

Learn more about this trial

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

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