MCII + MOVE! Program for Weight Management

(WOOP VA Trial)

Recruiting at 1 trial location

Overseen By Sandra Wittleder, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

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

405 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the idea that MCII + MOVE! Program for Weight Management is an effective treatment?

The available research shows that the MCII + MOVE! Program for Weight Management is effective. The study titled 'The effectiveness of telemedicine for weight management in the MOVE! Program' indicates that using videoconferencing technology for weight management treatment is effective. This suggests that the MCII + MOVE! Program, which includes similar telecommunication methods, can also be effective. Additionally, the study 'The effects of a telephone-based intervention on weight loss' supports the idea that minimal-contact and telephone-assisted programs can help with weight loss, which aligns with the methods used in the MCII + MOVE! Program. ^{1 2 3 4 5}

What safety data is available for the MCII + MOVE! weight management program?

The provided research does not specifically address safety data for the MCII + MOVE! program or its variations. The studies focus on the effectiveness and implementation of the MOVE! and TeleMOVE programs, primarily evaluating their reach, effectiveness, and adoption among veterans. Safety data specific to MCII or its related interventions like WOOP or mental contrasting with implementation intentions is not mentioned in the abstracts. ^{6 7 8 9 10}

Is the telephone-delivered MOVE! treatment a promising way to manage weight?

Yes, the telephone-delivered MOVE! treatment is promising for weight management. It helps veterans who can't easily access in-person programs by providing a home-based option. The program has been successful in reaching more veterans and increasing participation in weight management efforts. ^{7 8 10 11 12}

Research Team

Melanie R. Jay, MD MS

Principal Investigator

VA NY Harbor Healthcare System, New York, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of phone and e-mail lifestyle counseling for long term weight control among overweight employees. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Web Support for Weight-Loss Interventions: PREDIRCAM2 Clinical Trial Baseline Characteristics and Preliminary Results. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of a telephone-based intervention on weight loss. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of telemedicine for weight management in the MOVE! Program. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A comparison of MOVE! versus TeleMOVE programs for weight loss in Veterans with obesity. [2019]

7. Canada pubmed.ncbi.nlm.nih.gov

The Phased Implementation of a National Telehealth Weight Management Program for Veterans: Mixed-Methods Program Evaluation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a weight management program for veterans. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Video telehealth for weight maintenance of African-American women. [2022]

10. England pubmed.ncbi.nlm.nih.gov

RE-AIM evaluation of the Veterans Health Administration's MOVE! Weight Management Program. [2022]

11. England pubmed.ncbi.nlm.nih.gov

MOVE! multidisciplinary programs: Challenges and resources for weight management treatment in VHA. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Recruitment to mail and telephone interventions for obesity in a managed care environment: the Weigh-To-Be project. [2007]