Elements Vital to Treat Obesity Study

Not Applicable

Recruiting

• Conditions: Obesity
• Interventions: Behavioral: Smartphone App Participants (APP); Behavioral: Diabetes Prevention Program Participants (DPP)

• Registration Number: NCT04708769
• Lead Sponsor: Northwestern University

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Study Start: 2021-03-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-31
• Primary Completion: 2026-11-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

• BMI 30-45
• Weight stable
• Own a Smartphone and be willing to install our Smartphone app
• Willing to conduct video conference calls with study staff

Exclusion Criteria

• Enrolled in any formal weight loss program
• Taking anti-obesity medications
• Not taking medications that may cause weight gain
• Unstable medical conditions
• Diabetes requiring insulin supplementation
• Crohn's Disease
• Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
• Assistive devices for mobility
• Hospitalizations for a psychiatric disorder within the past 5 years
• Cardiovascular disease symptoms while performing moderate intensity exercise
• Pregnancy, trying to get pregnant, or lactating.
• Bulimia or binge eating disorder
• Reports of active suicidal ideation
• Current substance abuse or dependence besides nicotine dependence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone App Participants (APP)	Smartphone App Participants (APP)	Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist
Diabetes Prevention Program Participants (DPP)	Diabetes Prevention Program Participants (DPP)	Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist

Primary Outcome Measures

Name	Time	Method
Weight	Baseline to 6-Months	Participant change in weight, in kilograms, from baseline to 6-months.

Secondary Outcome Measures

Name	Time	Method
Costs of treatment	12 Months	Costs of EVO versus DPP implementation

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States