What is the mechanism of action of this treatment?

Behavioral modification and remote support are common treatments for obesity that focus on changing eating habits, increasing physical activity, and addressing psychological factors. These interventions create sustainable habits that lead to a caloric deficit and weight loss. Remote support, such as telehealth, provides continuous guidance and accountability, enhancing adherence to lifestyle changes. This approach is crucial for obesity patients as it improves overall health and reduces obesity-related comorbidities.

What side effects are associated with this type of intervention?

Common treatments for obesity, particularly behavioral interventions like cognitive-behavioral therapy (CBT) and lifestyle modifications, generally have minimal physical side effects but can include psychological challenges such as frustration or decreased motivation if weight loss is slow. Pharmacotherapy, including medications like orlistat, may cause gastrointestinal issues such as oily stools and flatulence, and in rare cases, liver injury. Combining these approaches with remote support can help mitigate psychological challenges by providing continuous motivation and support.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of obesity, including lorcaserin, phentermine, and the combination of bupropion-naltrexone. These medications are typically used as adjuncts to lifestyle interventions such as diet and exercise. Behavioral modification, including remote support, is an important component of obesity management. For instance, the combination of bupropion and naltrexone leverages behavioral aspects by reducing food intake through hypothalamic and midbrain mechanisms. Additionally, group lifestyle interventions over platforms like Zoom, paired with regular team meetings, are being studied to enhance weight loss outcomes in rural primary care settings.

What other types of research exist?

Promising, novel alternatives to Group Lifestyle Intervention for obesity patients include: 1) Internet-based behavioral obesity treatment, which has demonstrated efficacy comparable to in-person treatment. 2) Smartphone apps for weight control, offering accessible and user-friendly platforms for behavioral modification. 3) Social media-based interventions, such as Twitter-delivered support groups, which provide social support and behavior change strategies. 4) Telehealth coaching, combining remote consultations with personalized feedback and support.

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Telemedicine Lifestyle Coaching for Obesity (RE-TOOL Trial)

N/A

Recruiting

Led By Christie Befort, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on lifestyle changes rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. Psychological effects due to dietary changes could also occur.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent weight loss at 18 months

Secondary study objectives

Change in diet quality at 12 months

Change in diet quality at 18 months

Change in diet quality at 6 months

+23 more

Trial Design

2Treatment groups

Active Control

Group I: Local Care + ModelActive Control1 Intervention

Quarterly clinic visits with a local primary care provider

Group II: Team Care ModelActive Control1 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral modification and remote support are common treatments for obesity that focus on changing eating habits, increasing physical activity, and addressing psychological factors. These interventions create sustainable habits that lead to a caloric deficit and weight loss. Remote support, such as telehealth, provides continuous guidance and accountability, enhancing adherence to lifestyle changes. This approach is crucial for obesity patients as it improves overall health and reduces obesity-related comorbidities.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,842 Previous Clinical Trials

41,002,440 Total Patients Enrolled

49 Trials studying Obesity

31,678 Patients Enrolled for Obesity

University of Kansas Medical CenterLead Sponsor

488 Previous Clinical Trials

171,895 Total Patients Enrolled

21 Trials studying Obesity

103,192 Patients Enrolled for Obesity

Christie Befort, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

2 Previous Clinical Trials

1,912 Total Patients Enrolled

2 Trials studying Obesity

1,912 Patients Enrolled for Obesity

Media Library

Local Care + Model Clinical Trial Eligibility Overview. Trial Name: NCT05710510 — N/A

Obesity Research Study Groups: Local Care + Model, Team Care Model

Obesity Clinical Trial 2023: Local Care + Model Highlights & Side Effects. Trial Name: NCT05710510 — N/A

Local Care + Model 2023 Treatment Timeline for Medical Study. Trial Name: NCT05710510 — N/A

~308 spots leftby Aug 2026

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