Choosing Healthy Activities and Lifestyle Management Through Portal Support

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

Interventions

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.

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Tennessee

  lead OTHER

Principal Investigators

• Karen Johnson, MD · University of Tennessee

• Phyllis Richey, PhD · University of Tennessee

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-24

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations