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Behavioural Intervention

MCII + MOVE! Program for Weight Management (WOOP VA Trial)

New York, NY

N/A

Waitlist Available

Led By Melanie R. Jay, MD MS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Age 18-70

Must not have

a documented current history of active psychosis or other cognitive issues via ICD-10 codes

Diagnosed with Parkinson's disease and/or severe arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding a mental contrasting with implementation intentions (MCII) strategy to the VA's MOVE! weight management program will help Veterans who are enrolled in the program to lose weight.

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves lifestyle interventions like dietary changes and physical activity rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. Psychological discomfort could also occur from changing long-standing habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 70 years old.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with active psychosis or cognitive issues.

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

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in Self Reported Physical Activity

Healthy Eating Index change

MOVE! Attendance change

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mental Contrasting with Implementation Intentions (WOOP) plus MOVE! /TeleMOVE!Experimental Treatment4 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 Control2 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.

0 / 4Eligibility criteria met