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TOTAL Program for Obesity (TOTAL Trial)

N/A
Recruiting
Led By Luke M Funk, MD MPH
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
Veterans will be eligible for this study if they have a BMI of 30 kg/m2 or 27-29.9 + an obesity-related comorbidity
BMI of 30 kg/m2 or 27-29.9 + an obesity-related comorbidity
Must not have
Veterans will not be eligible for this study if they have cancer not in remission
Veterans will not be eligible for this study if they have severe hearing/visual impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trial will test a new intervention to help Veterans who are obese to lose weight. The intervention will involve an educational video and multiple motivational sessions delivered via telemedicine. If effective, this could be integrated into the existing VA behavioral weight management program, which is present at nearly every VA medical center.

Who is the study for?
This trial is for Veterans with obesity who haven't had bariatric surgery or used weight loss medications recently. They should have a BMI of at least 30, or 27-29.9 with an obesity-related health issue, and not attended the MOVE! program in the past year. Pregnant individuals, those planning pregnancy, breastfeeding mothers, cancer patients not in remission, and those without phone access or severe sensory impairments cannot join.
What is being tested?
The study tests TOTAL (Teaching Obesity Treatments to Adult Learners), which includes an educational video and motivational sessions via telemedicine against usual care within VA. It aims to see if this can increase treatment uptake and support weight loss among Veterans without needing many extra resources.
What are the potential side effects?
Since TOTAL primarily involves education and motivation through telemedicine sessions rather than medication or surgical interventions, significant side effects are not anticipated as part of this intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran with a BMI of 30 or higher, or between 27-29.9 with an obesity-related health issue.
Select...
My BMI is 30 or higher, or between 27-29.9 with an obesity-related health issue.
Select...
I am not taking any weight loss medications.
Select...
I have never had weight loss surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is in remission.
Select...
I do not have severe hearing or vision problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Obesity treatment initiation
Secondary study objectives
Bariatric surgery referral
Obesity medication initiation
Sustained obesity treatment
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TOTAL interventionExperimental Treatment1 Intervention
Participants randomized to this arm will watch the TOTAL intervention video and participate in 1:1 motivational sessions every 6 months. Participants will also complete assessments every 6 months.
Group II: Usual CareActive Control1 Intervention
Participants randomized to this arm will receive the usual obesity care, but will complete assessments every 6 months.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,576 Total Patients Enrolled
40 Trials studying Obesity
9,623 Patients Enrolled for Obesity
Luke M Funk, MD MPHPrincipal InvestigatorWilliam S. Middleton Memorial Veterans Hospital, Madison, WI
1 Previous Clinical Trials
42 Total Patients Enrolled
1 Trials studying Obesity
42 Patients Enrolled for Obesity

Media Library

Teaching Obesity Treatments to Adult Learners (TOTAL) Clinical Trial Eligibility Overview. Trial Name: NCT05346575 — N/A
Obesity Research Study Groups: TOTAL intervention, Usual Care
Obesity Clinical Trial 2023: Teaching Obesity Treatments to Adult Learners (TOTAL) Highlights & Side Effects. Trial Name: NCT05346575 — N/A
Teaching Obesity Treatments to Adult Learners (TOTAL) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346575 — N/A
~241 spots leftby May 2026
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