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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

TOTAL Trial 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.Check my eligibility

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.See study design

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.

TOTAL Trial 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.

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My BMI is 30 or higher, or between 27-29.9 with an obesity-related health issue.

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I am not taking any weight loss medications.

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I have never had weight loss surgery.

TOTAL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Obesity treatment initiation

Secondary outcome measures

Bariatric surgery referral

Obesity medication initiation

Sustained obesity treatment

+1 more

TOTAL 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,304,690 Total Patients Enrolled

40 Trials studying Obesity

9,593 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for individuals to qualify as participants of this medical experiment?

"This clinical trial, which has the capacity to accept up to 494 patients, seeks those who have obesity and are between 18-70 years of age."

Answered by AI

Is there availability for patients to join this research project?

"As per the information readily available on clinicaltrials.gov, this particular study is no longer recruiting patients as of November 3rd 2022. This trial had initially been published December 1st 2022 and was subsequently updated until its closure. However, 1132 other trials are still open for enrollment at present time."

Answered by AI