Clinical trial NCT05014984: WOOP VA: Promoting Weight Management in Primary Care
Official title: WOOP VA: Mental Contrasting With Implementation Intentions to Promote Weight Management in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: obesity
primary care
Weight management
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: New York University
First posted: 2021-08-20
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background: Approximately 40% of Veterans have obesity. Intensive weight management programs such as MOVE! promote clinically significant weight loss, but only 3-7% of eligible Veterans attend. Low enrollment and high attrition are due to obstacles such as travel, cost, and motivation. Developed through over 20 years of research, Mental Contrasting with Implementation Intentions (MCII) is a novel, evidence-based intervention to increase motivation and behavior change. MCII has been shown to increase physical activity and consumption of fruits and vegetables and promote weight loss, and the research team recently demonstrated that MCII is feasible and acceptable to Veterans for weight management. However, has not been tested adequately within primary care nor demonstrated weight loss in Veterans. The investigators propose to evaluate the efficacy and implementation of MCII for behavior change and weight loss in Veterans within primary care when combined with the VA MOVE! Program.

Significance/Impact: This proposal aligns with the VA HSRD "primary care practice and management of complex chronic diseases" funding priority. Primary care providers and PACT members do not provide sufficient counseling to increase engagement with the MOVE! Program. MCII can be taught by lay educators and can be delivered in conjunction with MOVE! and other weight management treatments.

Innovation: MCII is innovative in its use of imagery, ease of delivery by lay educators, novel mechanisms of action (via non-conscious motivational and cognitive processes), and ability to be combined with other programs. Veterans can practice MCII on their own in under 10 minutes. MCII uses a standardized, 4-step imagery procedure called WOOP that can be taught in 30 minutes. Veterans can then continue to use WOOP regularly, with the assistance of a WOOP App and website containing video-, audio-, and paper-based tools. This study will be the first randomized controlled trial of MCII within primary care and the first RCT to test the efficacy and implementation of MCII for weight management when combined with MOVE! in Veterans.

Specific Aims: 1. Compare the impact of MCII + MOVE!/TeleMOVE! vs. MOVE!/TeleMOVE! alone on percent weight change and waist circumference at 6 and 12 months. 2. Compare the impact of MCII + MOVE!/TeleMOVE! vs. MOVE!/TeleMOVE! alone on MOVE!/TeleMOVE! program attendance, healthy eating, and physical activity at 6 and 12 months. 3. Evaluate implementation of MCII. The investigators will use the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework to evaluate implementation barriers, facilitators, and outcomes of MCII.

Methodology: The investigators will enroll 405 Veterans and randomize 366 Veterans at the patient level within primary care to either MCII + telephone-delivered MOVE!/TeleMOVE! (intervention) vs. telephone-delivered MOVE!/TeleMOVE! alone (control) at the Manhattan VA. At 6 and 12 months, participants will return to the clinic for a study visit where weight, diet, and physical activity will be assessed in both groups. The investigators will use intention-to-treat analyses.

Implementation/Next Steps: MCII is designed to be easily implemented in a variety of settings and for a variety of behaviors. Freely available online training materials will facilitate implementation. To guide future implementation and policy change, the research team will present data from Aim 3 implementation analyses and obtain input from Veteran stakeholders as well as local VA and NCP leaders. If found to be efficacious, the investigators will conduct hybrid effectiveness/implementation studies of MCII in a multi-site study.

Eligibility criteria: Inclusion Criteria:

* Age 18-70 (this age range represents MOVE!/TeleMOVE! 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!/TeleMOVE! program or any local/national VA program that support weight management.

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 that might require joint or knee replacement in the next year;
* 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!/TeleMOVE! 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

Primary outcomes:
measure: Mean Percent Weight Change
timeFrame: 6 months
Secondary outcomes:
measure: Mean Percent Weight Change
timeFrame: 12 month
measure: Waist Circumference change
timeFrame: 6 and 12 months
measure: Healthy Eating Index change
timeFrame: baseline, 6 and 12 months
measure: Physical Activity--Weekly minutes of Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline, 6 and 12 months
measure: MOVE! Attendance change
timeFrame: Baseline, 6 and 12 months
measure: Change in Self Reported Physical Activity
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Melanie R. Jay, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vandyousefi S, Oettingen G, Wittleder S, Moin T, Sweat V, Aguilar AD, Ruan A, Angelotti G, Wong L, Orstad SL, Illengberger N, Nicholson A, Lim S, Cansler R, Portelli D, Sherman S, Jay MR. Protocol for a prospective, randomized, controlled trial of Mental Contrasting with Implementation Intentions (MCII) to enhance the effectiveness of VA's MOVE! weight management program: WOOP (Wish, Outcome, Obstacle, Plan) VA. Contemp Clin Trials. 2024 Jun;141:107523. doi: 10.1016/j.cct.2024.107523. Epub 2024 Apr 10.