MCII + MOVE! Program for Weight Management

(WOOP VA Trial)

Not currently recruiting at 1 trial location

Overseen By Sandra Wittleder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Weight loss drugs

Disqualifiers: Active psychosis, Parkinson's, pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans manage their weight through a program called MOVE!, delivered over the phone. Researchers are testing whether adding a technique called WOOP (Wish, Outcome, Obstacle, Plan) can improve motivation and weight loss results. Participants will receive either the standard MOVE! program or the enhanced version with WOOP. Veterans with a BMI of 30 or higher, or a BMI of 25 with an obesity-related condition like diabetes or heart disease, who wish to lose weight and can attend visits in Manhattan, may be eligible.

As an unphased trial, this study offers Veterans a unique opportunity to explore innovative weight management strategies.

Do I have to stop taking my current medications to join the trial?

The trial requires that you do not take any FDA-approved weight loss medications or certain diabetes drugs in the GLP-1 agonists class. If you are on these medications, you would need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, the Mental Contrasting with Implementation Intentions (MCII) strategy, which includes the WOOP technique (Wish, Outcome, Obstacle, Plan), proved to be safe and well-tolerated. Research over 20 years shows that MCII effectively boosts motivation for behavior change without harmful side effects. This strategy has been used successfully in various settings, including weight management programs like the VA's MOVE! program.

The MOVE! program is a well-established weight management strategy designed specifically for Veterans. It has been widely used and is generally considered safe. Combining MCII with MOVE! aims to improve motivation and results without introducing new safety concerns.

Overall, both the MCII technique and the MOVE! program have strong safety records based on existing research. Participants in clinical settings have not reported significant negative effects, indicating that the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MCII + MOVE! Program for Weight Management trial because it explores a novel approach to weight management by integrating mental contrasting with implementation intentions (WOOP) with the existing MOVE!/TeleMOVE! program. Unlike traditional weight management programs that focus primarily on diet and physical activity, this experimental arm introduces a psychological technique that helps individuals visualize their goals and develop concrete plans to overcome obstacles. By combining mental strategies with physical health education, the study aims to enhance the effectiveness of weight management efforts, potentially offering a more comprehensive solution for individuals struggling with weight issues.

What evidence suggests that this trial's treatments could be effective for weight management?

Research has shown that the MOVE! program, a treatment arm in this trial, helps people lose weight and change their habits. Studies have found that programs like MOVE!, which focus on lifestyle changes, can lead to a weight loss of 5% or more. Another treatment arm in this trial combines the MOVE! program with the MCII technique, also known as WOOP (Wish, Outcome, Obstacle, Plan). Developed over 20 years, MCII helps people stay motivated to change their behavior. Early results suggest that MCII can boost motivation through mental imagery, potentially enhancing the effectiveness of the MOVE! program. Together, these methods aim to help Veterans lose weight and improve their health. ^{1 3 6 7 8}

Who Is on the Research Team?

Melanie R. Jay, MD MS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Are You a Good Fit for This Trial?

This trial is for Veterans aged 18-70 with obesity or related conditions, willing to join the MOVE! program and able to attend evaluations in Manhattan VA. They must have had a primary care visit within the past year, desire weight loss, and be reachable by phone. Excluded are those seeing dietitians frequently, recently hospitalized, involved in other weight studies or taking certain weight loss drugs.

Inclusion Criteria

My BMI is 30 or higher, or it's 25 or higher with a related health condition.

I am willing to enroll in the MOVE! program.

I can travel to Manhattan VA for evaluations when needed.

Exclusion Criteria

I have been diagnosed with active psychosis or cognitive issues.

I have been diagnosed with Parkinson's disease or severe arthritis.

Non-Veterans

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants receive baseline assessments and are randomized into trial arms

1 day

1 visit (in-person)

Treatment

Participants receive either MCII + MOVE!/TeleMOVE! or MOVE!/TeleMOVE! alone

6 months

3 follow-up telephone check-ins for MCII group

Follow-up

Participants are monitored for weight, diet, and physical activity changes

6 months

2 visits (in-person) at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Information About Diet, Physical Activity, and Weight Management
• mental contrasting with implementation intentions
• telephone-delivered MOVE!
• Telephone MCII Check-ins

Trial Overview

The study tests whether adding Mental Contrasting with Implementation Intentions (MCII) strategy via 'WOOP' technique to telephone-delivered MOVE! enhances weight management compared to just using telephone-delivered MOVE!. Participants will receive guidance on diet and exercise during baseline visits and follow-up check-ins.

How Is the Trial Designed?

Group I: Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE! Experimental Treatment 4 Interventions

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!

Group II: Telephone Delivered MOVE!/TeleMOVE! Active Control 2 Interventions

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.

telephone-delivered MOVE! is already approved in United States for the following indications:

Approved in United States as MOVE! for:

• Weight management
• Obesity

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Published Research Related to This Trial

The MOVE! program from the Veteran's Health Administration has effectively supported weight management and physical activity, primarily through educational materials, but there are additional strategies that enhance its impact.

A case study and the establishment of a multidisciplinary, individualized weight management clinic demonstrate that higher treatment intensity can address the unique challenges faced by overweight and obese veterans, contributing to better program outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MOVE! multidisciplinary programs: Challenges and resources for weight management treatment in VHA. Rosenberger, PH., Ruser, C., Kashaf, S.[2021]

In a study involving 699 Veterans, the TeleMOVE program led to greater weight loss compared to the established MOVE! program, with TeleMOVE participants losing an average of 8.6 lbs (3.9 kg) versus 4.5 lbs (2.0 kg) for MOVE! participants.

Among highly adherent participants, TeleMOVE resulted in even more significant weight loss, with an average of 11.1 lbs (5.0 kg) lost compared to 5.7 lbs (2.6 kg) in MOVE!, and a higher percentage of TeleMOVE participants achieving clinically significant weight loss (43.1% vs. 13.5%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of MOVE! versus TeleMOVE programs for weight loss in Veterans with obesity. Rutledge, T., Skoyen, JA., Wiese, JA., et al.[2019]

Less than 5% of eligible veterans participated in the MOVE! Weight Management Program, indicating a significant gap in reach, particularly among younger veterans and those living farther from medical centers.

Participants who engaged more intensively in the program (with 6 or more encounters) experienced greater weight loss, averaging a loss of 3.7 pounds at 12 months, compared to nonparticipants, highlighting the importance of sustained engagement for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a weight management program for veterans. Littman, AJ., Boyko, EJ., McDonell, MB., et al.[2022]

A study involving 1801 members of a managed care organization found that mail- and telephone-based weight loss programs successfully recruited participants, but those who volunteered were generally heavier, younger, more educated, and predominantly women compared to the general overweight population.

The recruitment bias indicates that similar to traditional face-to-face interventions, these programs attract individuals with specific characteristics, such as a history of dieting and higher physical activity levels, highlighting the need for strategies to engage more men and older adults in future weight loss initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment to mail and telephone interventions for obesity in a managed care environment: the Weigh-To-Be project. Jeffery, RW., McGuire, MT., Brelje, KL., et al.[2007]

In a pilot study involving 45 obese patients with coronary heart disease, those who participated in a commercial weight management program (Weight Watchers) achieved a significant average weight loss of 5.8 kg, with 91% of participants losing weight.

After 14 weeks, 27 patients continued the program and experienced an even greater average weight loss of 9.1 kg, indicating that the program can be effective for long-term weight management in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. Minneboo, M., Peters, RJ., Miller-Kovach, K., et al.[2015]

In a 2-year randomized controlled trial involving 1386 overweight employees, the Internet-based weight-management program resulted in a modest weight loss of 1.2 kg, while the phone counseling group lost 0.8 kg, both compared to a self-directed control group.

Despite these results, neither the Internet nor phone counseling programs were significantly more effective than the self-help materials, indicating that personal counseling may not provide a substantial advantage for weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of phone and e-mail lifestyle counseling for long term weight control among overweight employees. van Wier, MF., Dekkers, JC., Hendriksen, IJ., et al.[2016]

In a clinical trial involving 183 participants with obesity, both telematic intervention (TI) and non-telematic intervention (NTI) groups showed significant weight loss at 3 and 6 months, with an average loss of approximately 3 kg, indicating the effectiveness of both approaches in obesity treatment.

The TI group experienced a slightly greater weight loss (1.61 kg more than NTI), but this difference was not statistically significant, suggesting that while web support may enhance weight loss, it does not outperform standard care in this preliminary analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. Alcántara-Aragón, V., Rodrigo-Cano, S., Lupianez-Barbero, A., et al.[2018]

In a study involving 64 participants over 24 weeks, the minimal-contact weight-loss program surprisingly resulted in nearly double the weight loss (12.7 lbs) compared to the telephone-assisted program (7.9 lbs).

Both minimal-contact and telephone-assisted programs can be effective for weight loss, but the modest results suggest that further research is needed to improve the design and content of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a telephone-based intervention on weight loss. Hellerstedt, WL., Jeffery, RW.[2018]

A study involving 60 veterans showed that those participating in a 12-week weight management program delivered via videoconferencing lost an average of 5.5 kg, while a control group gained weight, demonstrating the efficacy of this method.

The weight loss achieved by the MOVE! group was maintained for one year, suggesting that videoconferencing can be a sustainable long-term solution for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of telemedicine for weight management in the MOVE! Program. Ahrendt, AD., Kattelmann, KK., Rector, TS., et al.[2022]

The home telehealth intervention, which included telephone counseling and video support, did not significantly impact weight maintenance among 88 obese or overweight African-American women after a weight loss program, with both groups showing minimal weight change.

Low usage of the digital video recorders (DVRs) suggests that the video content may not have been effectively utilized, indicating a potential barrier to the success of the telehealth intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. Gerber, BS., Schiffer, L., Brown, AA., et al.[2022]

The MOVE! Weight Management Program for Veterans has significantly increased the screening and treatment of obesity among eligible patients in the Veterans Health Administration, with participation in weight management visits doubling since its implementation, although it has stabilized at only 10-12%.

Among patients who attended at least two treatment visits, 18.6% achieved a 5% weight loss within 6 months, compared to only 12.5% in a matched comparison group not receiving MOVE!, indicating that the program has a positive but modest impact on weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RE-AIM evaluation of the Veterans Health Administration's MOVE! Weight Management Program. Kahwati, LC., Lance, TX., Jones, KR., et al.[2022]

The TeleMOVE program, a home-based weight management initiative for veterans, showed comparable weight loss outcomes to standard facility-based MOVE services, with participants losing an average of -5.2 lbs in TeleMOVE and -5.1 lbs in MOVE! after 6 months.

Implementation success varied across sites, with high-uptake sites effectively overcoming challenges through strong communication and adaptability, while low-uptake sites struggled due to less leadership support and communication, highlighting the importance of contextual factors in program deployment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Phased Implementation of a National Telehealth Weight Management Program for Veterans: Mixed-Methods Program Evaluation. Goodrich, DE., Lowery, JC., Burns, JA., et al.[2020]

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