TOTAL Program for Obesity

(TOTAL Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an educational video and motivational sessions can help Veterans initiate and maintain obesity treatments, resulting in weight loss. It compares this new approach, the Teaching Obesity Treatments to Adult Learners (TOTAL) program, to the usual care for weight management. Veterans who have not attended a MOVE! program in the past year, have not undergone weight loss surgery, are not on weight loss medication, and have a BMI of 30 or a BMI between 27-29.9 with an obesity-related health issue might be suitable candidates.

As an unphased trial, this study provides Veterans with a unique opportunity to explore innovative weight management strategies.

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 prior data suggests that the TOTAL intervention is safe?

Research shows that the TOTAL program helps veterans learn about obesity treatments through an educational video and motivational sessions. This method aims to improve understanding and use of current weight management options. The program is non-invasive, meaning it doesn't involve medications or surgeries, which often reduces the risk of side effects.

The TOTAL program seeks to make existing obesity treatments more accessible and effective. By focusing on education, it is considered safe. Participants gain knowledge and motivation rather than undergoing direct medical treatments, resulting in no specific side effects linked to the program itself.

In summary, the TOTAL program is well-tolerated because it emphasizes education and motivation without introducing new medications or surgical risks. It offers a safe and supportive way for veterans to begin and maintain their weight management plans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TOTAL Program for Obesity because it focuses on education and personal motivation as a way to combat obesity, rather than relying solely on medication or surgery, which are common current treatments. The TOTAL intervention is unique because it involves watching an educational video and participating in one-on-one motivational sessions every six months, providing ongoing support and personalized strategies to help individuals manage their weight. This approach targets behavioral change and self-empowerment, which could offer a sustainable, long-term solution for weight management compared to traditional methods.

What evidence suggests that the TOTAL intervention is effective for obesity?

Research has shown that the TOTAL program, available to participants in this trial, might help more Veterans engage in obesity treatments. An earlier study found that the program, which includes an educational video and motivational sessions, was feasible and well-received by participants. The program educates Veterans about various obesity treatments, such as lifestyle changes, medications, and surgery. By enhancing understanding, TOTAL aims to encourage more Veterans to start and maintain a treatment plan. Early results suggest that this approach could enhance weight management efforts among Veterans. ^{1 6 7 8 9}

Who Is on the Research Team?

Luke M Funk, MD MPH

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8256180/

The TOTAL (Teaching Obesity Treatment Options to Adult ... TOTAL consisted of an 18-min video highlighting obesity health risks and treatment outcomes, eligibility criteria, and pros/cons of all three evidence-based ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34258469/

The TOTAL (Teaching Obesity Treatment Options to Adult ... Conclusions: TOTAL was feasible to implement, acceptable to Veterans, and has the potential to increase obesity treatment participation in VHA. An adequately ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05346575

Study Details | NCT05346575 | TOTAL: A Multisite RCT This study will evaluate the effectiveness of a novel intervention designed to increase obesity treatment initiation and subsequently weight loss within VA. The ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001940

The TOTAL trial for weight management participation The primary outcome is initiation of behavioral weight management treatment within 18 months of randomization. Secondary outcomes include sustained behavioral ...

5. withpower.com withpower.com/trial/phase-obesity-8-2022-e8b38

TOTAL Program for Obesity · Info for Participants The TOTAL treatment is unique because it focuses on educating adult learners, particularly Veterans, about all available obesity treatment options, including ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/23821205241269371

Perceptions of Adult Obesity Education: A Pilot Study Both faculty and trainees perceive that academic and clinical training on adult obesity is inadequate, and that trainees need more education.

7. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/obr.13769

Adult obesity treatment and prevention: A trans‐agency ... The multiple factors opposing weight loss and maintenance in persons with obesity, and the limitations of behavioral weight loss treatment alone ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2702877

Behavioral and Pharmacotherapy Weight Loss ... Objective To systematically review evidence on benefits and harms of behavioral and pharmacotherapy weight loss and weight loss maintenance ...