Teaching Novel Values-Based Skills to Improve Long-Term Weight Loss

  • STATUS
    Recruiting
  • days left to enroll
    15
  • participants needed
    480
  • sponsor
    The Miriam Hospital
Updated on 19 February 2024
body mass index
acceptance and commitment therapy

Summary

This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose 4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months.

Description

Obesity is a major public health problem, and although short-term weight loss is achievable, individuals often regain the majority of weight that was lost. Current approaches have adjusted behavioral prescriptions and lengthened treatment contact in an effort to address this problem, with modest effect. This NIDDK funded R01 project is a randomized controlled clinical trial to compare the efficacy of an intervention based on Acceptance and Commitment Therapy (ACT) and a Self-Regulation (SR) intervention on weight loss maintenance over a 30-month period. All participants will first complete a well-validated online weight loss intervention (months 1-3 of the study). Participants who lose 4 kilograms of initial weight will then be randomly assigned to receive ACT or SR, with both conditions consisting of face-to-face, group-based intervention meetings and weekly email contact for 6 months. The ACT intervention will target a novel theoretically derived intervention target, values-consistent behavior, which will help align weight loss goals with personal values and foster internal motivation to continue with weight control efforts. Assessments will be at baseline, post-weight loss/pre-randomization, and then 6, 12, 18, 24, and 30-month follow-up (months from randomization). This project will be conducted at the Weight Control and Diabetes Research Center (WCDRC). The WCDRC is part of the Centers for Behavioral and Preventive Medicine at The Miriam Hospital in Providence, Rhode Island, and the Department of Psychiatry and Human Behavior at the Alpert Medical School of Brown University. This study is significant because it addresses weight loss maintenance - a critical barrier to treating obesity - and results of the study could be used to improve long-term weight loss outcomes and associated health benefits for treatment seeing overweight and obese adults.

Details
Condition Overweight and Obesity
Age 25-70 years
Treatment Acceptance and Commitment Therapy (ACT), Self-Regulation (SR)
Clinical Study IdentifierNCT04256850
SponsorThe Miriam Hospital
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

English language fluent and literate at the 6th grade level
Body mass index (BMI) between 27.5 and 45 kg/m-squared
Able to walk 2 city blocks without stopping
Has reliable access to a computer with internet access

Exclusion Criteria

Currently participating in another weight loss program
Currently taking weight loss medication
Has lost 5% of body weight in the 6 months prior to enrolling
Has been pregnant within the 6 months prior to enrolling
Plans to become pregnant within 18 months of enrolling
Has a heart condition, chest pain during periods of activity or rest, or loss of consciousness in the 12 months prior to enrolling
Has any medical condition that would affect the safety of participating in unsupervised physical activity
Has any condition that would result in inability to follow the study protocol, including terminal illness and untreated major psychiatric illness
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