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Behavioural Intervention
MCII + MOVE! Program for Weight Management (WOOP VA Trial)
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 and 12 months
Awards & highlights
WOOP VA Trial 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.
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.
WOOP VA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 30 or higher, or it's 25 or higher with a related health condition.
Select...
I am between 18 and 70 years old.
WOOP VA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight Change
Secondary outcome measures
Change in Self Reported Physical Activity
Healthy Eating Index change
MOVE! Attendance change
+2 moreWOOP VA Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mental Contrasting with Implementation Intentions (WOOP) plus MOVE!Experimental Treatment4 Interventions
At the baseline visit, a lay educator will teach the WOOP technique in-person using protocols adapted from our prior work.12 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!
Group II: Telephone Delivered MOVE!Active Control2 Interventions
During the baseline visit, Veterans randomized to the control arm will receive only the standard information about MOVE!, diet, and physical activity delivered by the same lay educators. They will not learn the WOOP technique nor receive telephone follow up as detailed below. While we considered having an attention control with the same amount of contact, we decided that the study would be more pragmatic and findings would be more relevant to real-world practice if the control arm followed standard patient education and referral strategies. Data collection during study visits will be at the same timepoints in both arms.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,612 Previous Clinical Trials
3,305,377 Total Patients Enrolled
40 Trials studying Obesity
9,721 Patients Enrolled for Obesity
New York UniversityOTHER
226 Previous Clinical Trials
313,753 Total Patients Enrolled
5 Trials studying Obesity
2,652 Patients Enrolled for Obesity
Melanie R. Jay, MD MSPrincipal InvestigatorManhattan Campus of the VA NY Harbor Healthcare System, New York, NY
2 Previous Clinical Trials
326 Total Patients Enrolled
2 Trials studying Obesity
326 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- At least one prior PCP visit in the past year, access to a telephone, the ability to travel to Manhattan VA for in-person evaluations at baseline, 6 and 12 months.I want to lose weight and my desire is at least a 4 out of 10.I have been diagnosed with active psychosis or cognitive issues.My BMI is 30 or higher, or it's 25 or higher with a related health condition.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 have been diagnosed with Parkinson's disease or severe arthritis.I can travel to Manhattan VA for evaluations when needed.I am between 18 and 70 years old.I want to lose weight and my desire is at least a 5 out of 10.I am taking a prescribed weight loss medication.I am willing to enroll in the MOVE! program.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Telephone Delivered MOVE!
- Group 2: Mental Contrasting with Implementation Intentions (WOOP) plus MOVE!
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being considered for participation in this research endeavor?
"Affirmative. The information available on clinicaltrials.gov signposts that this medical research is actively looking for new enrollees, with the trial first being posted on February 15th 2022 and last updated on February 25th 2022. 366 volunteers are needed to be recruited from 1 site in particular."
Answered by AI
Are recruitment efforts currently underway for this trial?
"Affirmative. Documents hosted on clinicaltrials.gov demonstrate that this medical research, which began recruiting on February 15th 2022, is still active. 366 patients are being sought from a single trial site."
Answered by AI
Who meets the qualifications to participate in this research?
"This research endeavour is open to 366 adults between 18 and 70 with obesity. Eligible patients must consent to the MOVE! program, have a BMI of 30kg/m2 or 25kg/m2 plus an associated condition, prove they had at least one visit to their primary care physician in the last year, demonstrate access to a phone line, be willing and able travel into Manhattan VA for evaluations over three separate occasions throughout the study duration, as well as express a genuine intention of wanting lose weight (with an individual rating 4 out of 10)."
Answered by AI
Are elderly individuals excluded from this research project?
"Participation in this research study is contingent upon being older than 18 but younger than 70 years old."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
What portion of applicants met pre-screening criteria?
Met criteria
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