Choosing Healthy Activities and Lifestyle Management Through Portal Support

NCT05410353 | Active Not Recruiting DMC

• 2 other identifiers: 20-07328-FB5R01CA267643-03
• Study Type: interventional
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Weight Loss; Overweight and Obesity; Behavior, Health

Keywords

health information technology; electronic health record; patient portal

Outcome Measures

Primary Outcomes (1)

• Relative percentage change in weight

  This is calculated for each follow-up visit as ((weight at FU visit - baseline weight) / (baseline weight)) × 100%.

  12 months

Secondary Outcomes (3)

• Relationship of mutlitlevel determinants of health (screening tool) with weight change over time

  12 months

• Relationship of mutlilevel determinants of health (BRFSS) with weight change over time

  12 months

• Relationship of multilevel determinants of health (z codes) with weight change over time

  12 months

Study Arms (2)

Active Intervention Group

EXPERIMENTAL

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

Comparison Group

ACTIVE COMPARATOR

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

Interventions

Active Intervention Group BEHAVIORAL

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.

Also known as: Weight Loss, Adapted Look AHEAD ILI Group

Active Intervention Group

Comparison Group BEHAVIORAL

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.

Also known as: Adapted Look AHEAD DSE Group

Comparison Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Tennessee: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Tennessee Health Science Center / Department of Preventive Medicine

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

Weight Loss; Overweight; Obesity; Health Behavior

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Karen Johnson, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Phyllis Richey, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomized portion of this protocol will employ a blinding design so that the CHAMPS study personnel and investigators who are collecting and assessing outcome data (i.e., weight) will not know a participant's group assignment status (blinded to assignment). Neither the participants, nor the study staff who provide the intervention, will be blinded to assignment. All participants will be asked not to reveal their CHAMPS study group assignment to blinded clinic personnel. All intervention-related information will be kept separately from outcome data and will not be accessible to blinded staff.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-arm, parallel, randomized, controlled clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to either a behavioral weight loss intervention group delivered via Health IT with telephonic support (Active Intervention Group) or the Comparison Group. Because intervention delivery does not depend on clinic site, the study team has opted for a more powerful individual randomization over cluster randomization (but the team will potentially include clinic site as a grouping effect in the analysis).

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 8, 2022
• Study Start: February 24, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Release and share the data no later than the acceptance of publication of the main finding of the final dataset
• Access Criteria: Contact PI for access criteria

Locations

US (1)