Elements Vital to Treat Obesity Study (EVO)

Northwestern University

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: Diabetes Prevention Program Participants (DPP); Behavioral: Smartphone App Participants (APP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04708769

STU00212742

Details and patient eligibility

About

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.

Full 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.

Enrollment: 524 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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524 participants in 2 patient groups

Smartphone App Participants (APP)

Experimental group

Description:

Smartphone application, diet and activity goals, online lessons, brief remote sessions with a Health Promotionist

Treatment:

Behavioral: Smartphone App Participants (APP)

Diabetes Prevention Program Participants (DPP)

Experimental group

Description:

Participant program manual, diet and activity logs, hour long remote sessions with a Health Promotionist

Treatment:

Behavioral: Diabetes Prevention Program Participants (DPP)