Choosing Healthy Activities and Lifestyle Management Through Portal Support

Not Applicable

Recruiting

• Conditions: Overweight and Obesity; Behavior, Health; Weight Loss
• Interventions: Behavioral: Comparison Group; Behavioral: Active Intervention Group

• Registration Number: NCT05410353
• Lead Sponsor: University of Tennessee

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 underserved 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).

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 underserved 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 Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-08
• Study Start: 2023-02-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 an underserved group (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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison Group	Comparison Group	Look AHEAD DSE (Diabetes Support and Education) Comparison Group intervention adapted to be delivered via the EHR patient portal with telephonic support
Active Intervention Group	Active Intervention Group	Look AHEAD Intervention program adapted for delivery via Health IT modified for cultural and social norms applicable to under-served population groups

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Relationship of social determinants of health (screening tool) with weight change over time	12 months	How social determinants of health, assessed via the Social Needs Screening Tool, relate to patient success with weight loss
Relationship of social determinants of health (BRFSS) with weight change over time	12 months	How social 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
Relationship of social determinants of health (z codes) with weight change over time	12 months	How social 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

Trial Locations

Locations (1)

University of Tennessee Health Science Center / Department of Preventive Medicine; 🇺🇸 Memphis, Tennessee, United States