Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: SR; Behavioral: WLO; Behavioral: ACT

• Registration Number: NCT02156752
• Lead Sponsor: The Miriam Hospital

Brief Summary

This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-05
• Study Start: 2015-01
• Primary Completion: 2018-07-01
• Status Verified: 2019-08
• Study Completion: 2019-08-29
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• BMI 27.5-40
• Age 30-65

Exclusion Criteria

• currently participating in a weight loss program
• pregnant or planning to become pregnant
• medical condition that would preclude physical activity
• terminal illness
• plans to relocate
• history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SR	SR	Behavioral weight loss plus self-regulation techniques
WLO	WLO	Behavioral weight loss plus cooking tips and demonstrations
ACT	ACT	Behavioral weight loss plus techniques from Acceptance and Commitment Therapy

Primary Outcome Measures

Name	Time	Method
Weight	24 months

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States