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Elements Vital to Treat Obesity Study
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.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 16 March 2021
🗓️ Primary Completion (Estimated) 30 November 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 524
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 70 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 January 2021
  • First Submitted that Met QC Criteria 12 January 2021
  • First Posted 14 January 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 May 2024
  • Last Update Posted 31 May 2024
  • Last Verified May 2024
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