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OpenTrials
Completed

NCT Number: NCT02156752

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT

Behavioral

Treatment is based on Acceptance and Commitment Therapy

SR

Behavioral

Treatment is based on Self-Regulation theory.

WLO

Behavioral

Treatment is based on cooking tips and demonstrations.

Primary outcomes

  1. Weight

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 5, 2014
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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