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WOOP VA: Promoting Weight Management in Primary Care
Approximately 40% of Veterans have obesity and are at increased risk for cardiometabolic disease. Intensive lifestyle-based weight management programs can lead to clinically significant ( 5%) weight loss. The VA's MOVE! program is effective for promoting weight loss and behavior change for those who attend. Unfortunately, MOVE! has low enrollment and high attrition due to several obstacles including low motivation. Mental Contrasting with Implementation Intentions (MCII) is an innovative strategy developed over 20 years of research that uses imagery to increase motivation for behavior change. MCII can be implemented in primary care settings using an easy to teach technique called "WOOP" (Wish, Outcome, Obstacle, Plan) that Veterans then use regularly on their own with the help of paper-based tools or the WOOP app. The research team will evaluate the efficacy and implementation of MCII when combined with telephone-delivered MOVE! vs. telephone-delivered MOVE! alone to enhance weight management outcomes for Veterans in primary care.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 15 February 2022
🗓️ Primary Completion (Estimated) 30 June 2025
✅ Study Completion (Estimated) 29 August 2025
👥 Enrollment (Estimated) 366
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age 18-70 (this age range represents MOVE! eligibility);
    • * The most recent BMI of 30kg/m2 (with or without obesity-associated comorbidities) OR a BMI of 25kg/m2 with obesity-associated condition (heart diseases, hyperlipidemia, hypertension, cancer, diabetes, stroke, or osteoarthritis);
    • * at least 1 prior PCP visit in the past 24 months; access to a telephone; ability to travel to Manhattan VA for in-person evaluations at baseline, 6 and 12 months;
    • * desire to lose weight (Using 1-10 scale used in PI's other studies; minimum of 5/10);
    • * willingness to enroll in the MOVE! program.

    Exclusion Criteria:

    • * Non-Veterans;
    • * a documented current history of active psychosis or other cognitive issues via ICD-10 codes;
    • * Diagnosed with Parkinson's disease and/or severe arthritis;
    • * participating in a weight management study in the past year;
    • * taking an FDA-approved weight loss medication; Bupropion-naltrexone (Contrave) Liraglutide (Saxenda) Orlistat (Xenical)/alli Phentermine-topiramate (Qsymia) Phentermine Topiramate Lorcaserin / Belviq glucagon-like peptide 1 (GLP-1) agonists:
    • Diabetes drugs in the GLP-1 agonists class include:
    • Dulaglutide (Trulicity) Exenatide extended release (Bydureon) Exenatide (Byetta) Semaglutide (Ozempic) Semaglutide (Rybelsus) Liraglutide (Victoza) Lixisenatide (Adlyxin) Metformin to lose weight not for your diabetes;
    • * pregnancy;
    • * PCP stating that Veteran should not participate.
    • * Seeing a dietitian or MOVE! Program attendance more than 3 times in the past year.
    • * Hospitalization within 90 days of enrollment.
    • * Anyone who is included in Dr. Jose Aleman weight management clinic
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 4 August 2021
  • First Submitted that Met QC Criteria 13 August 2021
  • First Posted 20 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 February 2024
  • Last Update Posted 13 February 2024
  • Last Verified February 2024
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