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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02156752
Enrollment
190
Registered
2014-06-05
Start date
2015-01-31
Completion date
2019-08-29
Last updated
2019-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORALACT

Treatment is based on Acceptance and Commitment Therapy

BEHAVIORALSR

Treatment is based on Self-Regulation theory.

BEHAVIORALWLO

Treatment is based on cooking tips and demonstrations.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
The Miriam Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Weight24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026