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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

CHAMPS Trial Summary

This trial will test whether a weight loss intervention delivered through health IT tools can help people lose more weight than a diabetes support and education intervention.

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.Check my eligibility
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.See study design
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.

CHAMPS Trial 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.

CHAMPS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Relative percentage change in weight
Secondary outcome measures
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

CHAMPS 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,631 Total Patients Enrolled
48 Trials studying Obesity
31,238 Patients Enrolled for Obesity
Regional One HealthOTHER
4 Previous Clinical Trials
743 Total Patients Enrolled
University of TennesseeLead Sponsor
189 Previous Clinical Trials
141,779 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

Frequently Asked Questions

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

Is enrollment for this research initiative still open to participants?

"Confirmed, this study is not enrolling patients. The trial was initially advertised on January 1st 2023 and its status last changed on June 8th 2022. Nevertheless, there are currently 1293 other clinical trials with open enrollment requirements."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
University of Tennessee Health Science Center / Department of Preventive Medicine
Recent research and studies
clinicaltrials.govStudy
Choosing Healthy Activities and Lifestyle Management Through Portal Support
2023. "Choosing Healthy Activities and Lifestyle Management Through Portal Support". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05410353.
All > Weight Loss
~167 spots leftby Jun 2027
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