Telemedicine Lifestyle Coaching for Obesity

(RE-TOOL Trial)

Overseen By Christie Befort, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Recent myocardial infarction, stroke, cancer, others

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

Compensation: Varies

Number of Visits: 6

Duration: 18 months

560 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods to help obese patients in rural areas lose weight. One method involves regular one-on-one meetings with a doctor, while the other includes group coaching sessions over Zoom plus regular meetings with both a doctor and a coach. The goal is to see which method is more effective at supporting weight loss over time.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is telemedicine lifestyle coaching for obesity safe for humans?

The research on telemedicine lifestyle coaching for obesity, including models like the Team-Based Model and TelemedTeam, generally focuses on weight management and does not report any specific safety concerns. These programs are designed to be delivered by trained health professionals and often include remote counseling, which is considered safe for participants. ^{1 2 3 4 5}

How is the Telemedicine Lifestyle Coaching for Obesity treatment different from other obesity treatments?

This treatment is unique because it uses telemedicine to provide lifestyle coaching, making it accessible to people in rural areas who may have limited access to obesity care. It combines personal coaching with a team-based approach, involving primary care providers and other specialists, to support long-term weight loss and health behavior changes. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Telemedicine Lifestyle Coaching for Obesity?

Research shows that telemedicine, including phone and text support, can effectively help people stick to lifestyle changes and improve health outcomes in obesity management. Additionally, telemedicine has been successful in increasing access to obesity treatment in rural areas, leading to improved weight status and reduced health disparities. ^{1 2 8 9 10}

Who Is on the Research Team?

Christie Befort, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking rural residents with obesity (BMI >= 30 kg/m2) who can walk unaided and have seen their primary care provider in the past year. They need internet access or a smartphone, and physician clearance to join. People with recent major health events like heart attacks or strokes, those pregnant or planning pregnancy, breastfeeding, having had bariatric surgery recently, or with end-stage diseases are excluded.

Inclusion Criteria

Seen at least once in their primary care clinic within the past year

Rural resident

Physician clearance to participate

Exclusion Criteria

Currently breastfeeding

I had weight loss surgery within the last two years.

I have had a heart attack in the last six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either quarterly 1:1 meetings with their primary care provider or a group lifestyle intervention over Zoom paired with quarterly team meetings.

18 months

6 quarterly clinic visits, 30 counseling sessions for Team Care arm

Follow-up

Participants are monitored for changes in weight, diet quality, and quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Local Care + Model
• Team Care Model

Trial Overview The study compares two obesity management methods over 18 months: one involves quarterly one-on-one meetings between participants and their doctors; the other combines group lifestyle interventions via Zoom with team meetings including a coach.

How Is the Trial Designed?

Group I: Local Care + Model Active Control 1 Intervention

Quarterly clinic visits with a local primary care provider

Group II: Team Care Model Active Control 1 Intervention

An intensive group lifestyle intervention led by a lifestyle coach via Zoom, paired with quarterly clinic visits with a local primary care provider and the lifestyle coach, the coach joining via telemedicine.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The TeleFIT program successfully increased access to pediatric obesity treatment for rural families, with the number of patients nearly tripling in the first year and continuing to grow, indicating a significant improvement in service utilization.

Preliminary results show that attrition rates and weight status improvements for patients using TeleFIT are comparable to those receiving conventional treatment, suggesting that telemedicine can effectively address obesity in underserved rural communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TeleFIT: adapting a multidisciplinary, tertiary-care pediatric obesity clinic to rural populations. Irby, MB., Boles, KA., Jordan, C., et al.[2021]

Participants in a telehealth trial for obesity management reported that telephone and text message support were highly beneficial, providing motivation and accountability.

The study indicates strong acceptability of these communication methods, suggesting they could be effectively integrated into community-based obesity management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. Lewis, E., Hassmén, P., Pumpa, KL.[2021]

This trial will evaluate the effectiveness of remote weight management interventions (group phone conferences and individual phone calls) for overweight and obese adults in rural areas, addressing the challenge of travel to traditional programs.

Two hundred participants will be randomized into three groups (group phone, individual phone, and enhanced usual care) to compare weight loss and maintenance over 24 months, with outcomes measured at multiple time points to assess the interventions' impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight management in rural health clinics: The Midwest diet and exercise trial. Gorczyca, AM., Washburn, RA., Ptomey, L., et al.[2021]

An online lifestyle intervention coaching protocol was developed based on the Diabetes Prevention Program, aiming to provide effective obesity treatment in primary care settings.

This e-counseling approach allows for high-quality lifestyle advice to be accessible to patients who cannot attend in-person sessions due to scheduling or geographic limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. Simkin-Silverman, LR., Conroy, MB., Bhargava, T., et al.[2018]

This study evaluates three different obesity treatment models in rural primary care, involving 36 practices and 1440 patients over 24 months, to determine which is most effective for weight loss.

The research aims to compare the effectiveness of a fee-for-service model, a patient-centered medical home approach, and a centralized disease management model, with the expectation that the latter two will lead to greater weight loss outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) Trial: Comparing three obesity treatment models in rural primary care. Befort, CA., VanWormer, JJ., DeSouza, C., et al.[2017]

A telemedicine weight management program called Wellness Connect was implemented in rural South Carolina, where 138 patients participated, and 62% completed the program, demonstrating its feasibility in areas with limited access to obesity treatment.

Patients who completed the program lost an average of 3.5% of their body weight, which is statistically significant, indicating that telemedicine can effectively support weight loss in rural populations despite challenges in sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Description, utilisation and results from a telehealth primary care weight management intervention for adults with obesity in South Carolina. Brown, JD., Hales, S., Evans, TE., et al.[2020]

The Obesity Care Model Collaborative (OCMC) developed a comprehensive framework for obesity management in primary care, involving 10 diverse health care organizations over an 18-month period, which included tailored interventions across community, organizational, care team, and patient/family domains.

Key interventions included training staff, establishing quality monitoring systems, and creating community partnerships, all aimed at enhancing the effectiveness of obesity treatment in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building Successful Models in Primary Care to Improve the Management of Adult Patients with Obesity. Casanova, D., Kushner, RF., Ciemins, EL., et al.[2021]

The study aims to evaluate an integrated obesity management system that combines training, coaching, and a virtual community for primary care physicians (PCPs), hypothesizing it will improve obesity screening and management in patients with weight-related diseases.

By enrolling 22 patients per family medicine group and assessing their care over 18 months, the research will measure the effectiveness of the intervention on weight loss and patient satisfaction, highlighting the importance of supporting PCPs in managing obesity effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an integrated obesity management system on patient's care - research protocol. Baillargeon, JP., St-Cyr-Tribble, D., Xhignesse, M., et al.[2023]

Overweight employees participating in a telemedical coaching program lost an average of 3.1 kg over 12 weeks and maintained this weight loss after one year, significantly outperforming the control group which showed no change.

Both telemedical and telemedical coaching interventions led to reductions in BMI, waist circumference, and LDL cholesterol, with the coaching group also improving blood pressure and cholesterol levels, indicating a comprehensive health benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. Kempf, K., Röhling, M., Stichert, M., et al.[2022]

The Healthy Weight Clinic model enhances child obesity care by integrating specialized visits from a trained team, including a pediatric provider, nutritionist, and case manager, directly within community health centers.

This approach not only increases access to specialized care but also emphasizes health behavior change and utilizes health information technology to improve the quality of care for managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialized care of overweight children in community health centers. Anand, SG., Adams, WG., Zuckerman, BS.[2010]

Citations

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

TeleFIT: adapting a multidisciplinary, tertiary-care pediatric obesity clinic to rural populations. [2021]

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

Participant perspectives of a telehealth trial investigating the use of telephone and text message support in obesity management: a qualitative evaluation. [2021]

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

Weight management in rural health clinics: The Midwest diet and exercise trial. [2021]

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

Development of an online diabetes prevention lifestyle intervention coaching protocol for use in primary care practice. [2018]

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

Protocol for the Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER) Trial: Comparing three obesity treatment models in rural primary care. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Description, utilisation and results from a telehealth primary care weight management intervention for adults with obesity in South Carolina. [2020]

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

Building Successful Models in Primary Care to Improve the Management of Adult Patients with Obesity. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Impact of an integrated obesity management system on patient's care - research protocol. [2023]

9. Egypt pubmed.ncbi.nlm.nih.gov

Telemedical Coaching Improves Long-Term Weight Loss in Overweight Persons: A Randomized Controlled Trial. [2022]

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

Specialized care of overweight children in community health centers. [2010]