- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756973
The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Object: The current study examined the efficacy, feasibility, and acceptability of: 1) adding self-compassion (SC) skills training to a standard behavioral weight loss program (BWLP), and 2) utilizing video conferencing software to deliver small group, weekly, weight loss classes.
Method: The BWLP program utilized Webex video conferencing software to deliver a 12-week, interactive, small group, weekly weight loss intervention. Participants were randomized to a standard BWLP or a standard behavioral weight loss program augmented with self-compassion skills training (BWLP+SC).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Greenville, North Carolina, United States, 27858
- East Carolina University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard weight loss
A 12 week small group weight loss intervention delivered via video teleconference technology.
|
A 12 week small group weight loss program delivered via teleconference video technology
|
|
Experimental: Standard weight loss plus self-compassion skills training
A 12 week small group weight loss intervention delivered via video teleconference technology.
|
A 12 week small group weight loss program delivered via teleconference video technology
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
weight loss
Time Frame: 12 weeks
|
Weight in kilograms
|
12 weeks
|
|
height
Time Frame: baseline
|
meters
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-compassion
Time Frame: 12 weeks
|
Change in self-compassion scale score from pre to post
|
12 weeks
|
|
Eating Behaviors
Time Frame: 12 weeks
|
Change in eating behaviors scale from pre to post
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Carels, East Carolina University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMCIRB 20-001508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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