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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02156752
Recruitment Status : Completed
First Posted : June 5, 2014
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE May 22, 2014
First Posted Date  ICMJE June 5, 2014
Last Update Posted Date September 18, 2019
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2014)		 Weight [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: ACT
    Behavioral weight loss plus techniques from Acceptance and Commitment Therapy
    Intervention: Behavioral: ACT
  • Active Comparator: SR
    Behavioral weight loss plus self-regulation techniques
    Intervention: Behavioral: SR
  • Active Comparator: WLO
    Behavioral weight loss plus cooking tips and demonstrations
    Intervention: Behavioral: WLO
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 3, 2014)		 190
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 29, 2019
Actual Primary Completion Date July 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02156752
Other Study ID Numbers  ICMJE 5K23KDK097143
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The Miriam Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Miriam Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Jason Lillis, Ph.D. Lifespan/ The Miriam Hospital
PRS Account The Miriam Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP