A Self-compassion Focused Intervention for Internalized Weight Bias and Weight Loss
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2023
CompletedFirst Posted
Study publicly available on registry
August 14, 2023
CompletedStudy Start
First participant enrolled
September 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedNovember 14, 2023
November 1, 2023
7 months
July 25, 2023
November 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Intervention
EXPERIMENTALa standard weight loss and internalized weight bias intervention with self-compassion exercises
Interventions
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.
Eligibility Criteria
You may qualify if:
- BMI ≥ 25, ≥ 18 years old
- Smartphone access
- WBIS score ≥ 4
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Carolina Universitylead
- University of South Alabamacollaborator
Study Sites (2)
East Carolina University
Greenville, North Carolina, 27858, United States
ECU, Dept of Psychology, 104 Rawl
Greenville, North Carolina, 27858, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Carels
East Carolina University
Central Study Contacts
Abbie Metzler
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2023
First Posted
August 14, 2023
Study Start
September 24, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
I am happy to make data available to qualified researchers.