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Health IT-Supported Weight Loss Intervention for Obesity (CHAMPS Trial)

N/A
Recruiting
Led By Karen Johnson, MD
Research Sponsored by University of Tennessee
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are ≥ 16 years old
Patients are overweight or obese (BMI ≥ 25 kg/m2)
Must not have
History of amputation or bariatric surgery or planning to have bariatric surgery within the next 12 months
Current weight loss medication use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial tests a weight loss program using online health tools and phone support for underserved groups. It aims to help people lose weight by providing easy access to diet and exercise advice through their health records. The study focuses on groups with high obesity rates who often face challenges in accessing effective weight loss programs.

Who is the study for?
This trial is for overweight or obese individuals (BMI ≥ 25 kg/m2) who are at least 16 years old, have internet access, and belong to underserved groups. They must be patients at participating sites and willing to be randomly assigned to a group. People with certain medical conditions, uncontrolled psychiatric disorders, substance abuse issues, recent major surgeries or cancer (except skin cancer), current weight loss medication use, or plans that conflict with the study's timeline cannot join.
What is being tested?
The trial tests if a behavioral weight loss program delivered through Health IT tools via patient portals leads to more weight loss after one year compared to a standard support group. The Active Intervention Group receives an adapted version of the Look AHEAD intensive lifestyle intervention while the Comparison Group gets basic diabetes support education.
What are the potential side effects?
Since this is a behavioral intervention focusing on lifestyle changes rather than medication or surgery, side effects may include typical responses to diet change and increased physical activity such as muscle soreness, fatigue during adjustment periods, potential dietary deficiencies if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 16 years old or older.
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My BMI is 25 or higher, indicating I am overweight or obese.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an amputation, bariatric surgery, or plan to within a year.
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I am currently taking medication to lose weight.
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I have not had cancer (other than skin cancer) in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Relative percentage change in weight
Secondary study objectives
Relationship of social determinants of health (BRFSS) with weight change over time
Relationship of social determinants of health (screening tool) with weight change over time
Relationship of social determinants of health (z codes) with weight change over time

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Active Intervention GroupExperimental Treatment1 Intervention
Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups
Group II: Comparison GroupActive Control1 Intervention
Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support

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
Common treatments for obesity, particularly those involving behavioral modification through Health IT tools, work by combining dietary changes, increased physical activity, and behavioral strategies. These interventions aim to reduce caloric intake, enhance physical fitness, and modify eating behaviors. Health IT tools, such as EHR and patient portals, support these efforts by offering personalized feedback, continuous monitoring, and easier tracking of progress. This integrated approach is crucial for obesity patients as it provides a structured, accessible, and engaging way to adhere to weight loss programs, thereby improving the likelihood of successful outcomes.
Interventions to Treat Obesity in Mexican Children and Adolescents: Systematic Review and Meta-Analysis.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,750 Total Patients Enrolled
49 Trials studying Obesity
31,988 Patients Enrolled for Obesity
Regional One HealthOTHER
4 Previous Clinical Trials
743 Total Patients Enrolled
University of TennesseeLead Sponsor
195 Previous Clinical Trials
144,156 Total Patients Enrolled
19 Trials studying Obesity
3,426 Patients Enrolled for Obesity

Media Library

Active Intervention Group Clinical Trial Eligibility Overview. Trial Name: NCT05410353 — N/A
~157 spots leftby Jun 2027
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