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Clinical Trials/NCT02156752
NCT02156752CompletedNot Applicable

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

The Miriam Hospital2 sites in 1 country190 target enrollmentStarted: January 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
190
Locations
2
Primary Endpoint
Weight

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
30 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

ACT

Experimental

Behavioral weight loss plus techniques from Acceptance and Commitment Therapy

Intervention: ACT (Behavioral)

SR

Active Comparator

Behavioral weight loss plus self-regulation techniques

Intervention: SR (Behavioral)

WLO

Active Comparator

Behavioral weight loss plus cooking tips and demonstrations

Intervention: WLO (Behavioral)

Outcomes

Primary Outcomes

Weight

Time Frame: 24 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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