Choosing Healthy Activities and Lifestyle Management Through Portal Support (CHAMPS)

November 19, 2025 updated by: University of Tennessee

Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk

The study aims to randomize 250 participants to 1 of 2 arms: a.) an Active Intervention Group (based on the Look AHEAD* ILI) or b.) a Comparison Group (based on the Look AHEAD DSE Comparison group) to test the hypothesis that a multicomponent, multilevel behavioral weight loss intervention (Active Intervention Group) adapted for different population groups and delivered through Health Information Technology (Health IT) tools via the Electronic Health Record (EHR) patient portal, will result in significantly greater weight loss 12 months after enrollment compared to the Comparison Group.

*The Look AHEAD study was a multi-center, randomized clinical trial involving overweight and obese persons with type 2 diabetes, aimed to determine the effects on the cardiovascular outcomes of an intensive lifestyle intervention (ILI) for weight loss, in comparison to the diabetes support and education intervention (DSE).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This project tests whether the adapted Look AHEAD Intensive Lifestyle Intervention (ILI) will result in significant weight loss when delivered through Health IT - EHR patient portal compared to a Comparison group (based on Look AHEAD DSE Comparison group). This project will be conducted in 2 stages: a formative assessment stage (Stage 1) and a clinical trial stage (Stage 2).

During Stage 1, we will modify the interactive technology-based Look AHEAD ILI that we already developed for the TARGIT study (Active Intervention group). We will also adapt the Look AHEAD Comparison condition (DSE group) for our Comparison condition. We will also optimize the protocol for acceptability in different populations and in a rural setting.

During Stage 2, we will randomly assign 250 participants to either the Comparison Group or the Active Intervention Group to address the primary aim of testing the hypothesis that a multicomponent, behavioral weight loss intervention delivered through Health IT - patient portal will lead to significantly greater weight loss 12 months after enrollment in the Active Intervention group compared with the Comparison group. Our Health IT-based intervention is potentially cost-effective and thus disseminable to any practice-based physician group with access to an EHR with a patient portal.

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • University of Tennessee Health Science Center / Department of Preventive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. are ≥ 16 years old
  2. are overweight or obese (BMI ≥ 25 kg/m2)
  3. have access to the Internet via the computer or use a cellphone with a data-plan access
  4. are patients at one of the participating practice sites
  5. are willing to accept a random assignment, and
  6. are from different population groups (racial / ethnic minority, lower socioeconomic status, or reside in a rural location).

Exclusion Criteria:

  1. coronary or cerebrovascular disease events or vascular procedures within the past 6 months
  2. certain medical conditions that put participants at high risk of adverse events or preclude exercising
  3. uncontrolled psychiatric disorders
  4. current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days
  5. a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months
  6. current weight loss medication use
  7. malignancy within the last 5 years (except skin cancer)
  8. plans to move out of the area during the next year
  9. current participation in another clinical trial
  10. pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and
  11. instances judged by the investigators' and primary care providers' discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparison Group
Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support
Behavioral: Comparison Group
All participants in the Comparison Group will receive a mandatory 13 contacts per year including 3 informational sessions on nutrition, physical activity and social support and 10 contacts via patient portal or email regarding intervention topics. The Look AHEAD Comparison Group was designed to be realistic, achievable, and an acceptable intervention that encouraged optimal study retention.
Other Names:
  • Adapted Look AHEAD DSE Group
Experimental: Active Intervention Group
Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to different population groups
Behavioral: Active Intervention Group
The 3 major intervention components are diet, physical activity, and the behavioral modification curriculum. Scheduled interactions are educational podcasts (a series of audiovisual, digital media files) paired with a follow-up phone counseling session with a trained behavioral interventionist. A patient portal message will be sent to participants when a new podcast is posted. Interactive sessions will be weekly (weeks 1-16), biweekly (weeks 17-24), and monthly (weeks 25-52). The goal for weight loss is ≥ 7% of initial weight over the course of 12 months. Participants will restrict caloric intake with the goal of 1,200-1,500 kcal/day for those weighing < 114 kg and 1,500-1,800 kcal/day for those weighing ≥ 114 kg. The physical activity goal will be for participants to gradually increase to 175-200 minutes of moderate-intensity activity per week by the 24th week. Participants will also be asked to self-monitor their dietary intake and physical activity using the "Lose It!" app.
Other Names:
  • Weight Loss
  • Adapted Look AHEAD ILI Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative percentage change in weight
Time Frame: 12 months
This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship of mutlitlevel determinants of health (screening tool) with weight change over time
Time Frame: 12 months
How multilevel determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss
12 months
Relationship of mutlilevel determinants of health (BRFSS) with weight change over time
Time Frame: 12 months
How multilevel determinants of health, assessed via the Social Determinants of Health Questions Adapted from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 Questionnaire, relate to patient success with weight loss
12 months
Relationship of multilevel determinants of health (z codes) with weight change over time
Time Frame: 12 months
How multilevel determinants of health, assessed using z codes for Social Determinants of Health constructs abstracted from the Electronic Health Record using ICD -10 codes, relate to patient success with weight loss
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen Johnson, MD, University of Tennessee
  • Principal Investigator: Phyllis Richey, PhD, University of Tennessee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-07328-FB
  • 5R01CA267643-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will prepare and distribute a dataset maintaining confidentiality of individual participants. The final study analytical database will be processed according to HIPAA definitions for public data sharing and participant data will be de-identified using processes such as: removal of identifiers, translation of dates and ages to delta time values, and assignment of random study identifiers. A series of de-identified data files representing the final analytical data set will be available and provided in a standard format that is readable across a variety of applications and operating system platforms. Other documentation may include: data dictionary, data code book, valid variable ranges, protocol, MOP, intervention manual or programs, and any electronic versions of any paper forms that were used. The data release documentation will provide detailed, organized documentation of study variables and clear instructions on how to install and access the data.

IPD Sharing Time Frame

Release and share the data no later than the acceptance of publication of the main finding of the final dataset

IPD Sharing Access Criteria

Contact PI for access criteria

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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