ObesityWOOP VANCT05014984
WOOP VA: Promoting Weight Management in Primary Care
A study testing mental contrasting with implementation intentions, telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! and Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- mental contrasting with implementation intentions, telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! and Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
About this study
Official title: WOOP VA: Mental Contrasting With Implementation Intentions to Promote 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- mental contrasting with implementation intentions, telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE!, Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All, Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit)
- Keywords
- obesity, primary care, Weight management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mental contrasting with implementation intentionsBehavioural
Also called WOOP (Wish, Outcome, Obstacle, Plan)
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
telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE!Behavioural
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!.
Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): AllBehavioural
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.
Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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! Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 12 month
Waist Circumference change
The RA will use an inelastic tape scaled in cm to measure the participant's waist circumference twice at the peak of the iliac crests, taking the average of the 2 measures rounded down to the nearest 0.25cm.
Measured: 6 and 12 months
Healthy Eating Index change
The HEI-2015 is a diet quality index that measures alignment with the 2015-2020 Dietary Guidelines for Americans. To measure dietary intake at each time point, we will use an automated, cost-effective and valid 24-hour dietary recall instrument for measuring diet quality. The web-based Automated Self-Administered 24-Hour Recall (ASA24-2020), developed by the National Cancer Institute and first released in 2009 was modeled after the US Department of Agriculture's interviewer- administered Automated Multiple-Pass Method (AMPM). To limit participant burden, participants will perform one weekday measurement (self-administered in person with staff available to answer questions as needed) and one weekend measurement (self-administered at home). While at least three 24-hour recall measurements are considered the gold standard, two measurements are valid. If we cannot obtain a weekend measure, we will obtain two weekday measures and account for this in the analysis.
Measured: baseline, 6 and 12 months
Physical Activity--Weekly minutes of Moderate to Vigorous Physical Activity (MVPA)
The research team will use the ActiGraph Link (GT9X) accelerometer to objectively measure PA during a 7-day period. During an initial enrollment visit, RAs will place the Link monitor on the participant's non-dominant wrist and instruct the participant to measure PA for 24 hours a day for 7 days, except when swimming and bathing, and to return the monitor at the baseline visit two weeks later. We will use accelerometer data to report weekly minutes of MVPA.
Measured: Baseline, 6 and 12 months
MOVE! Attendance change
A chart review will be done to verify the number of MOVE! sessions completed.
Measured: Baseline, 6 and 12 months
Change in Self Reported Physical Activity
Self-reported weekly minutes of MVPA will be measured via the Global Physical Activity Questionnaire (GPAQ).
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Feb 2022
- Primary completion30 Jun 2025
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- New York University
- Responsible party
- Sponsor
- Investigators
- Melanie R. Jay, MD MS, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014984
- Sponsor's protocol ID
- IIR 20-153
- Acronym
- WOOP VA
- Status last verified
- May 2026
- First submitted
- 4 Aug 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38608752
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WOOP VA: Mental Contrasting With Implementation Intentions to Promote Weight Management in Primary Care
- ClinicalTrials.gov ID
- NCT05014984
- Acronym / sponsor ID
- WOOP VA / IIR 20-153
- Conditions
- Obesity
- Keywords
- obesity, primary care, Weight management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- New York University
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Telephone Delivered MOVE!/TeleMOVE! | Active comparator | 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): AllDuring 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. |
| Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE! | Experimental | 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)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! |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mental contrasting with implementation intentionsAlso: WOOP (Wish, Outcome, Obstacle, Plan)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 | Behavioural | Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE! |
| telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE!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!. | Behavioural | 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): AllAll 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. | Behavioural | 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)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. | Behavioural | Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE! |
Primary outcome
Mean Percent Weight Change
Time frame: 6 months
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 secondary outcomes
Mean Percent Weight Change
Time frame: 12 month
Waist Circumference change
Time frame: 6 and 12 months
Healthy Eating Index change
Time frame: baseline, 6 and 12 months
Physical Activity--Weekly minutes of Moderate to Vigorous Physical Activity (MVPA)
Time frame: Baseline, 6 and 12 months
MOVE! Attendance change
Time frame: Baseline, 6 and 12 months
Change in Self Reported Physical Activity
Time frame: Baseline, 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Results publication: PubMed 38608752Vandyousefi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie R. Jay, MD MS principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mental contrasting with implementation intentions, telephone-delivered, telehealth-delivered, and or in-person MOVE! or TeleMOVE! and Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Weight Change (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.