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

NCT02156752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2019-09-18

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

ACT

Treatment is based on Acceptance and Commitment Therapy

BEHAVIORAL

SR

Treatment is based on Self-Regulation theory.

BEHAVIORAL

WLO

Treatment is based on cooking tips and demonstrations.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Jason Lillis, Ph.D. · Lifespan/ The Miriam Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-07-01
Completion
2019-08-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156752 on ClinicalTrials.gov