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Behavioural Intervention

Telehealth Weight Loss Program for Obesity

N/A

Waitlist Available

Led By John Batsis, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Obesity (Body mass index [BMI] ≥30kg/m^2)

≥2 of the 21 Medicare-defined chronic conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0, 8, 16, 26, 52, 78

Awards & highlights

Study Summary

This trial seeks to find the best initial weight loss intervention for older adults with obesity & multiple chronic conditions. Results could improve health & quality of life, reduce disability & lower healthcare costs.

Who is the study for?

This trial is for English-speaking adults aged 65-85 with obesity (BMI ≥30) and at least two chronic conditions as defined by Medicare. Participants must be able to consent, have a stable weight in the past 12 weeks, and get medical clearance from their doctor. Those with recent COVID-19, dementia, bariatric surgery history, or certain severe health issues cannot join.Check my eligibility

What is being tested?

The study tests different combinations of prescriptive and behavioral interventions to find effective weight loss strategies for older adults with multiple chronic conditions using a SMART design. It aims to identify treatments that improve health outcomes and reduce healthcare costs.See study design

What are the potential side effects?

Since this trial focuses on lifestyle changes rather than medication, side effects may include typical reactions to diet adjustments or increased physical activity such as muscle soreness, fatigue, or digestive changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is 30 or higher.

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I have two or more long-term health conditions.

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I can understand and make decisions about my treatment.

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I have a disability score of 6 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0, 8, 16, 26, 52, 78

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0, 8, 16, 26, 52, 78

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0, 8, 16, 26, 52, 78 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in weight from baseline

Secondary outcome measures

Acceptability of Study Intervention

Attendance

Change in % body fat from baseline

+39 more

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Responders to Prescriptive- Continue PrescriptiveExperimental Treatment1 Intervention

The prescriptive strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the prescriptive intervention. Participants will continue their diet and exercise programs that were initially tailored to them.

Group II: Responders to Behavioral- Continue BehavioralExperimental Treatment1 Intervention

The behavioral strategy will continue among participants who responded to this intervention well initially, meaning that participants who lost greater than or equal to 2.5 percent (%) of their body weight using the behavioral intervention.

Group III: Non-responders to Prescriptive- Switch to BehavioralExperimental Treatment1 Intervention

Participants who lost less than 2.5 percent (%) of their body weight initially will be randomized to a different type of intervention. One possibility could be that participants switch first-line treatment from a prescriptive strategy to the alternative (behavioral) as participants may need motivation or problem-solving.

Group IV: Non-responders to Prescriptive- Combination of Prescriptive and BehavioralExperimental Treatment2 Interventions

Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention- three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.

Group V: Non-responders to Behavioral- Switch to PrescriptiveExperimental Treatment1 Intervention

Group VI: Non-responders to Behavioral- Combination of Prescriptive and BehavioralExperimental Treatment2 Interventions

Participants who lost less than 2.5 percent (%) of their body weight early on will be re-randomized to a different type of intervention. One possibility could be that participants will have a combined prescriptive and behavioral intervention - three guideline-advised strategies that may be synergistic in a subset of participants requiring knowledge, and needing goal setting and problem-solving skills. This approach is available in multispecialty, tertiary care obesity clinics.

Group VII: BehavioralActive Control1 Intervention

Health coaches have a bachelor's degree and take a 6-8-week certification program. Health coaches will use a structured manual involving evidence-based behavior change techniques (problem-solving, self-regulation, motivation). Group and individual sessions will be via telemedicine. Conceptual model targets include: barrier identification: problem-solving to identify and address barriers to meet goals self-regulation: a focus on self-monitoring and behavior goals with feedback autonomous motivation: self-selecting goals, motivational interviewing use, and creating plans; and (d) self-efficacy: learning from group experiences, verbal persuasion, and encouraging pursuit of goals in the face of setbacks.

Group VIII: PrescriptiveActive Control1 Intervention

A diet and exercise prescription individually tailored to each participant's multiple chronic health conditions will provide concrete advice with less autonomy, and will minimize risks of physiologic changes due to weight loss (hypoglycemia, hypotension, muscle loss). Licensed, trained professionals- Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will introduce clinical reasoning, knowledge, and experience, assess biological adaptations to weight loss, modify prescriptions based on changing medical needs, and provide real-time and asynchronous guidance. Registered Dietician Nutritionists (RDNs) and Physical Therapists (PTs) will deliver group and individual, live sessions to the home by telemedicine. Sessions will last 60-min (Registered Dietician Nutritionist: 20 min; Physical Therapy: 40 min).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral

2018

Completed Phase 4

~1160

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,508 Previous Clinical Trials

4,190,436 Total Patients Enrolled

2 Trials studying Multiple Chronic Conditions

25 Patients Enrolled for Multiple Chronic Conditions

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,883 Total Patients Enrolled

3 Trials studying Multiple Chronic Conditions

60 Patients Enrolled for Multiple Chronic Conditions

John Batsis, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants over 60 excluded from participation in this research?

"This research is welcoming individuals aged over 65 and less than 85 years of age to participate."

Answered by AI

For what demographic is participation in this medical trial most appropriate?

"In order to enroll in this research, participants must have a preexisting health condition and be between 65-85 years of age. The study is currently recruiting 180 volunteers for its duration."

Answered by AI

Are there still opportunities for participation in this trial?

"According to clinicaltrials.gov, this trial is not currently seeking volunteers; the study was initially posted on February 1st 2024 and recently updated on September 19th 2023. Although this research opportunity isn't available presently, there are over twelve hundred other trials that are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults

2024. "Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06044571.