NCT04708769

Elements Vital to Treat Obesity Study

Evaluating the EVO Treatment Optimized for Resource Constraints: Elements Vital to Treat Obesity.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 524 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The overall objective of this study is to evaluate the first rigorously optimized, remotely delivered treatment for obesity against the current gold standard treatment in a head-to-head randomized controlled trial. The investigators will be comparing the previously developed and optimized behavioral weight loss intervention (APP) to the Diabetes Prevention Program (DPP), to evaluate program weight-loss success and cost-effectiveness.

Detailed description

The proposed study seeks to determine if the APP program is an effective, resource-sensitive strategy to manage weight for obesity, as compared to the DPP program. During the 24-week active intervention phase, participants will be randomized to one of two treatments: 1) APP, wherein participants receive calorie, fat, and physical activity goals via a Smartphone application for self-monitoring, online educational readings, and biweekly sessions with a Health Promotionist; or 2) DPP, wherein participants are guided to self-monitor their physical activity, food intake, and weight via a participant log, and are guided through 16 sessions by a Health Promotionist. Assessments to track progress will occur remotely at the 3-month, 6-month, and 12-month time points of the program.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Smartphone App Participants (APP)	Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
BEHAVIORAL	Diabetes Prevention Program Participants (DPP)	In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.

Timeline

• Start date: 2021-03-16
• Primary completion: 2026-01-07
• Completion: 2026-06-30
• First posted: 2021-01-14
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States