TOTAL Program for Obesity

(TOTAL Trial)

Recruiting at 1 trial location

Overseen By Corrine I Voils, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Weight loss medications

Disqualifiers: Pregnancy, Cancer, Hearing/visual impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

440 Participants Needed

Trial Summary

What is the purpose of this trial?

Nearly 8 in 10 Veterans meet criteria for overweight/obesity. Three evidence-based treatment options are available within VA (behavioral weight management \[MOVE!\], obesity medications, and bariatric surgery). However, all treatments are significantly underutilized. This study will evaluate the effectiveness of a novel intervention designed to increase obesity treatment initiation and subsequently weight loss within VA. The intervention, Teaching Obesity Treatment Options to Adult Learners (TOTAL), involves an educational video and multiple motivational sessions delivered via telemedicine. If effective, TOTAL could be implemented throughout VA without requiring significant resources and could be integrated into the existing VA behavioral weight management program, MOVE!, which is present at nearly every VA medical center.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on weight loss medications to participate.

What data supports the effectiveness of the TOTAL treatment for obesity?

The TOTAL treatment, which focuses on educating adults about obesity management, is supported by research showing that educational programs can improve counseling confidence and patient outcomes. Additionally, behavior therapy and group support have been found to facilitate behavior change and improve health-related outcomes in weight reduction interventions. ^{1 2 3 4 5}

How is the TOTAL treatment for obesity different from other treatments?

The TOTAL treatment is unique because it focuses on educating adult learners, particularly Veterans, about all available obesity treatment options, including behavioral management, medications, and surgery, to increase their participation in these treatments. ^{6 7 8 9 10}

Research Team

Luke M Funk, MD MPH

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Eligibility Criteria

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.

Inclusion Criteria

Veterans will be eligible for this study if they have no previous bariatric surgery

I am a veteran with a BMI of 30 or higher, or between 27-29.9 with an obesity-related health issue.

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

Exclusion Criteria

Veterans will not be eligible for this study if they are pregnant or are planning to become pregnant within the study period

My cancer is in remission.

I do not have severe hearing or vision problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants watch an 18-minute educational video and participate in three motivational sessions delivered via telemedicine

18 months

Sessions every 6 months

Assessment

Participants complete assessments every 6 months to measure outcomes such as MOVE! initiation, obesity medication use, and weight change

18 months

Assessments every 6 months

Follow-up

Participants are monitored for sustained obesity treatment and other outcomes post-intervention

18 months

Treatment Details

Interventions

• Teaching Obesity Treatments to Adult Learners (TOTAL)

Trial Overview 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.

Participant Groups

Group I: TOTAL intervention Experimental Treatment 1 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 Care Active Control 1 Intervention

Participants randomized to this arm will receive the usual obesity care, but will complete assessments every 6 months.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A systematic review of 27 studies from 2005 to 2018 revealed a significant lack of obesity education programs for medical students, residents, and fellows worldwide, despite the high prevalence of obesity.

When obesity education programs were implemented, they notably improved outcomes such as counseling confidence, which received an overall grade A, indicating that enhancing education in this area could lead to better treatment for patients with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity education in medical schools, residencies, and fellowships throughout the world: a systematic review. Mastrocola, MR., Roque, SS., Benning, LV., et al.[2021]

A structured multidisciplinary non-surgical obesity therapy program led to significant weight loss over 52 weeks, with females losing an average of 19.6 kg and males 26.0 kg, demonstrating its effectiveness in treating obesity.

The program also resulted in a 50% reduction in the prevalence of metabolic syndrome and a decrease in hypertension rates from 47% to 29%, indicating substantial health benefits beyond weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life--a prospective study. Bischoff, SC., Damms-Machado, A., Betz, C., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[The role of patient education in bariatric surgery]. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Obesity education in medical schools, residencies, and fellowships throughout the world: a systematic review. [2021]

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

Weight reduction interventions for persons with a chronic illness: findings and factors for consideration. [2007]

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

An Evidence-Based Approach to Teaching Obesity Management to Medical Students. [2023]

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

A MOOC About Bariatric Surgery Improves Knowledge and Promotes Patients' Soft Skills. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of a Teaching Kitchen Curriculum for Health Professional Trainees in Nutrition Knowledge, Confidence, and Skills to Advance Obesity Prevention and Management in Clinical Practice. [2023]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

Use of cognitive-behavioral approach to overweight and obesity therapy in STOB activities. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Transdisciplinary Obesity Prevention Research Sciences (TOPRS) Curriculum Increases Knowledge About Complex Causes and Consequences of Obesity for Undergraduate Students. [2020]

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

Multicenter evaluation of an interdisciplinary 52-week weight loss program for obesity with regard to body weight, comorbidities and quality of life--a prospective study. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Protocol and short-term results for a feasibility randomized controlled trial of a video intervention for Veterans with obesity: The TOTAL (Teaching Obesity Treatment Options to Adult Learners) pilot study. [2022]