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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best way to help people in rural areas manage obesity by comparing two different approaches. The Local Care + Model involves meeting one-on-one with a local doctor every few months. The Team Care Model adds group lifestyle coaching sessions over Zoom. The researchers aim to determine which method helps participants lose more weight over 18 months. Individuals who live in rural areas, have a BMI of 30 or higher, can walk without assistance, and have internet access might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative solutions for obesity management in rural communities.

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.

What prior data suggests that these methods for managing obesity are safe?

Research has shown that both the Local Care + Model and the Team Care Model are generally safe for managing obesity. In the Local Care + Model, studies have found that participants improve their diet and activity levels, leading to positive weight changes without major safety concerns. This model includes regular meetings with a doctor to monitor any health issues that might arise.

The Team Care Model is also safe and effective, using similar telehealth lifestyle methods. It involves group sessions led by a coach on Zoom, providing a supportive way to make lifestyle changes. Previous participants successfully lost weight and increased their physical activity with this approach.

Overall, both methods focus on non-invasive lifestyle changes, making them well-tolerated options for managing weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for obesity because they bring telemedicine into the mix, offering greater flexibility and accessibility. Unlike traditional face-to-face sessions, the Team Care Model delivers intensive lifestyle coaching via Zoom, making it easier for participants to fit into their busy lives. It combines this with regular local clinic visits, ensuring personalized care without losing the benefits of group support. The integration of digital tools could potentially enhance engagement and help people stick to healthier lifestyle changes long-term, which is a fresh approach compared to the standard diet and exercise counseling typically offered in clinics.

What evidence suggests that this trial's treatments could be effective for managing obesity?

Research shows that both telemedicine and regular doctor visits can help manage obesity. In past studies, patients improved their diet, exercise habits, and lost weight by meeting regularly with their doctor. This method supports making healthier lifestyle choices and losing weight over time.

In this trial, participants will be assigned to one of two models. The Local Care + Model involves quarterly clinic visits with a local primary care provider. Meanwhile, the Team Care Model includes 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 joining via telemedicine. Studies have found that intensive group sessions combined with telemedicine, as in the Team Care Model, can lead to significant weight loss. Participants in similar programs lost about 6.5 kg (around 14 pounds) after one year. These programs also lowered the risk of developing diabetes by 58%. Both methods are effective, with the Team Care Model offering strong long-term benefits. ^{1 2 3 4 5}

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

BMI: >= 30 kg/m2

Rural resident

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 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]

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]

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]

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]

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]

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554059/

Protocol for the rural engagement in TelemedTeam ... This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model ...

2. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-016-0396-x

Telemedicine and primary care obesity management in rural ... Results noted improvements in diet, activity levels, and favorable changes in weight [64]. This same study group identified barriers in rural ...

3. withpower.com withpower.com/trial/phase-obesity-2-2023-1c1b1

Telemedicine Lifestyle Coaching for Obesity (RE-TOOL 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, ...

4. researchgate.net researchgate.net/publication/396468815_Protocol_for_the_Rural_Engagement_in_TelemedTeam_for_Options_in_Obesity_Treatment_Solutions_RE-TOOL_Cluster_randomized_trial_investigating_team-based_telemedicine_in_rural_primary_care

Protocol for the Rural Engagement in TelemedTeam ... ... obesity management in primary care. In this paper we describe the role of interdisciplinary collaboration, or lack thereof, in patient weight ...

5. read.qxmd.com read.qxmd.com/read/41146915/protocol-for-the-rural-engagement-in-telemedteam-for-options-in-obesity-treatment-solutions-re-tool-cluster-randomized-trial-investigating-team-based-telemedicine-in-rural-primary-care

Protocol for the rural engagement in TelemedTeam ... This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the ...