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The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software

Primary Purpose

Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral weight loss program
Sponsored by
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

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

Inclusion Criteria:

  • 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups

Exclusion Criteria:

-

Sites / Locations

  • East Carolina University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard weight loss

Standard weight loss plus self-compassion skills training

Arm Description

A 12 week small group weight loss intervention delivered via video teleconference technology.

A 12 week small group weight loss intervention delivered via video teleconference technology.

Outcomes

Primary Outcome Measures

weight loss
Weight in kilograms
height
meters

Secondary Outcome Measures

Self-compassion
Change in self-compassion scale score from pre to post
Eating Behaviors
Change in eating behaviors scale from pre to post

Full Information

First Posted
February 11, 2021
Last Updated
February 15, 2021
Sponsor
East Carolina University
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1. Study Identification

Unique Protocol Identification Number
NCT04756973
Brief Title
The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software
Official Title
The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 25, 2020 (Actual)
Study Completion Date
November 25, 2020 (Actual)

3. Sponsor/Collaborators

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

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 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard weight loss
Arm Type
Active Comparator
Arm Description
A 12 week small group weight loss intervention delivered via video teleconference technology.
Arm Title
Standard weight loss plus self-compassion skills training
Arm Type
Experimental
Arm Description
A 12 week small group weight loss intervention delivered via video teleconference technology.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral weight loss program
Intervention Description
A 12 week small group weight loss program delivered via teleconference video technology
Primary Outcome Measure Information:
Title
weight loss
Description
Weight in kilograms
Time Frame
12 weeks
Title
height
Description
meters
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Self-compassion
Description
Change in self-compassion scale score from pre to post
Time Frame
12 weeks
Title
Eating Behaviors
Description
Change in eating behaviors scale from pre to post
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: 18 or older, at a BMI of 27 kg/m2 or greater, and available to attend weekly online groups Exclusion Criteria: -
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Addition of Self-compassion Skills Training to a Behavioral Weight Loss Program Delivered Using Video Conferencing Software

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