Elements Vital to Treat Obesity Study

Last updated: July 7, 2025
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Smartphone App Participants (APP)

Diabetes Prevention Program Participants (DPP)

Clinical Study ID

NCT04708769
STU00212742
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 524
Treatment Group(s): 2
Primary Treatment: Smartphone App Participants (APP)
Phase:
Study Start date:
March 16, 2021
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

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