WOOP VA: Promoting Weight Management in Primary Care

NCT05014984 | Completed

• 1 other identifier: IIR 20-153
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; primary care; Weight management

Outcome Measures

Primary Outcomes (1)

• Mean Percent Weight Change

  The research team will measure weight using a standardized protocol, taking the average of 2 weights in pounds, rounded to the nearest 0.1lb.

  6 months

Secondary Outcomes (6)

• Mean Percent Weight Change

  12 month

• Waist Circumference change

  6 and 12 months

• Healthy Eating Index change

  baseline, 6 and 12 months

• Physical Activity--Weekly minutes of Moderate to Vigorous Physical Activity (MVPA)

  Baseline, 6 and 12 months

• MOVE! Attendance change

  Baseline, 6 and 12 months

Study Arms (2)

Telephone Delivered MOVE!/TeleMOVE!

ACTIVE COMPARATOR

During the baseline visit, Veterans randomized to the control arm will receive only the standard information about MOVE!/TeleMOVE!, diet, and physical activity delivered by the same lay educators. They will not learn the WOOP technique as detailed below. Data collection during study visits will be at the same timepoints in both arms.

Behavioral: telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE!; Behavioral: Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All

Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!

EXPERIMENTAL

At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work. After, to support WOOP practice, the lay educator will schedule and provide 3 follow-up telephone check-ins with the Veteran. This arm will also receive telephone-delivered MOVE!/TeleMOVE!

Behavioral: mental contrasting with implementation intentions; Behavioral: telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE!; Behavioral: Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All; Behavioral: Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit)

Interventions

mental contrasting with implementation intentions BEHAVIORAL

To deliver MCII, Dr. Oettingen developed a step-wise procedure called WOOP (Wish, Outcome, Obstacle, Plan; Figure 1). In a quiet setting, patients identify an important wish (e.g., losing weight) and then name and vividly imagine the best outcome (e.g., feeling healthier). Next, they name a current internal obstacle (e.g., urge to eat when feeling stressed) and try to vividly imagine their experience when they encounter this obstacle. Finally, they address their obstacle with an if-then plan specifying when, where, and how to overcome it (e.g., "If I have the urge to eat when feeling stressed, I will go for a walk)" and then imagine themselves experiencing the obstacle and carrying out the action of surmounting it. To facilitate use of the WOOP technique, Dr. Oettingen developed a free, publicly available WOOP app

Also known as: WOOP (Wish, Outcome, Obstacle, Plan)

Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!

telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! BEHAVIORAL

MOVE! is a national VA weight management and health promotion program to improve the quality of life of Veterans.6,75 This effective program encourages healthy eating behavior and increased physical activity. MOVE! will be delivered via telephone (16 sessions) by existing staff consistent with national MOVE! program guidelines. The program has 16 modules and will offered weekly, but Veterans will be able to make up sessions at their own pace if they miss one. MOVE! staff use the MOVE! facilitator guide that provides instruction on delivering the program via telephone. Update as of 11-2023, the New York Harbor VA paused their offering of telephone-delivered MOVE!. Participants in both arms are offered the in-person or video-delivered MOVE! program. For participants who do not want or are unable to attend group-based MOVE!, they are offered TeleMOVE!.

Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!; Telephone Delivered MOVE!/TeleMOVE!

Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All BEHAVIORAL

All participants will receive handouts that they review with a lay educator on weight management, adapted from the educational materials developed for our FIReWoRk Study. Topics include losing weight at a healthy rate, setting a 6-month weight loss goal of 5-10%, limiting sugar-sweetened beverages and portion sizes, making better choices when eating at restaurants, self-monitoring diet and weight, and participating in at least moderate-intensity physical activities.

Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!; Telephone Delivered MOVE!/TeleMOVE!

Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit) BEHAVIORAL

The lay educator will review and practice the WOOP technique based on protocols from prior studies. To probe Veterans' comprehension, the lay educator will ask for their four steps and ask about their WOOP use and experiences. If needed, the lay educator will help the Veteran to create a new WOOP for the next month and address any questions and concerns about using WOOP.

Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• New York University: collaborator

Study Sites (1)

VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

Location

Related Publications (1)

• 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.

  PMID: 38608752 RESULT

MeSH Terms

Conditions

Obesity

Interventions

Exercise; Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Melanie R. Jay, MD MS

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study staff, investigators, and outcome assessors will be blinded to the intervention arm. The lay health coach interventionist and the participant will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized controlled trial

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 20, 2021
• Study Start: February 15, 2022
• Primary Completion: June 30, 2025
• Study Completion: February 11, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)