A Novel Intervention for Weight Loss in Young Adults
Obesity and cardiometabolic risks are significant public health issues, with about two-thirds of U.S. adults overweight or obese. Weight loss can prevent these health problems, but current lifestyle interventions have limited success. New, effective strategies are needed to address this rising issue at the population level. The goal of this clinical trial is to investigate how a behavioral intervention combined with technology impacts weight loss in young adults. The main questions it aims to answer are: • How does the combination of behavioral intervention and technology influence weight loss in young adults?
Conditions:
🦠 Weight Loss
🗓️ Study Start (Actual) 5 June 2024
🗓️ Primary Completion (Estimated) June 2028
✅ Study Completion (Estimated) June 2028
👥 Enrollment (Estimated) 320
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Overweight or obese (BMI 25.5- 34.9 kg/m2) men and women
    • * Ages 18 to 40 years
    • * Weight stable (no change \>25 lbs in the past 3 months)
    • * Owns a smartphone and willing to install the study app

    Exclusion Criteria:

    • * Presence of obstructive sleep apnea or history of any other sleep disorder.
    • * Irregular menses, menopausal symptoms or post-menopausal, currently pregnant, trying to get pregnant or nursing
    • * Regular travel across time zones
    • * Subjects who are currently following a weight loss regimen or any other special diet or exercise programs
    • * Increased fractional lean body mass (e.g., athletes)
    • * Unable to walk, using an assistive device for mobility, or any contraindications to exercise
    • * Diabetes
    • * Claustrophobia
    • * Excessive alcohol (\>2 drinks/day) or caffeine (\>300mg/day) intake, regular nicotine use, substance abuse.
    • * Abnormal findings on screening blood testing.
    • * Participants taking any prescription, over-the-counter drugs/supplements that can affect sleep or weight.
    • * Major psychiatric or any eating disorder, and any acute or chronic medical condition that increase the risk of interventions (e.g., heart disease)
    • * Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class\>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 months
Ages Eligible for Study: 18 Years to 40 Years (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 19 January 2024
  • First Submitted that Met QC Criteria 19 January 2024
  • First Posted 30 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 July 2024
  • Last Update Posted 18 July 2024
  • Last Verified July 2024