- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02156752
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
September 16, 2019 updated by: The Miriam Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
190
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Weight Control and Diabetes Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACT
Behavioral weight loss plus techniques from Acceptance and Commitment Therapy
|
Treatment is based on Acceptance and Commitment Therapy
|
Active Comparator: SR
Behavioral weight loss plus self-regulation techniques
|
Treatment is based on Self-Regulation theory.
|
Active Comparator: WLO
Behavioral weight loss plus cooking tips and demonstrations
|
Treatment is based on cooking tips and demonstrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jason Lillis, Ph.D., Lifespan/ The Miriam Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lillis J, Dunsiger S, Thomas JG, Ross KM, Wing RR. Novel behavioral interventions to improve long-term weight loss: A randomized trial of acceptance and commitment therapy or self-regulation for weight loss maintenance. J Behav Med. 2021 Aug;44(4):527-540. doi: 10.1007/s10865-021-00215-z. Epub 2021 Mar 27.
- Lillis J, Thomas JG, Levin ME, Wing RR. Self-stigma and weight loss: The impact of fear of being stigmatized. J Health Psychol. 2020 Jun;25(7):922-930. doi: 10.1177/1359105317739101. Epub 2017 Nov 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
August 29, 2019
Study Registration Dates
First Submitted
May 22, 2014
First Submitted That Met QC Criteria
June 3, 2014
First Posted (Estimate)
June 5, 2014
Study Record Updates
Last Update Posted (Actual)
September 18, 2019
Last Update Submitted That Met QC Criteria
September 16, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 5K23KDK097143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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