NCT04756973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 11, 2021

Last Update Submit

February 15, 2021

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (2)

  • weight loss

    Weight in kilograms

    12 weeks

  • height

    meters

    baseline

Secondary Outcomes (2)

  • Self-compassion

    12 weeks

  • Eating Behaviors

    12 weeks

Study Arms (2)

Standard weight loss

ACTIVE COMPARATOR

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

Behavioral: Behavioral weight loss program

Standard weight loss plus self-compassion skills training

EXPERIMENTAL

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

Behavioral: Behavioral weight loss program

Interventions

Behavioral weight loss programBEHAVIORAL

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

Standard weight lossStandard weight loss plus self-compassion skills training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Carolina University

Greenville, North Carolina, 27858, United States

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Carels

    East Carolina University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

July 1, 2020

Primary Completion

November 25, 2020

Study Completion

November 25, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)