Recruiting

Weight Loss

Sponsor:

University of Chicago

Code:

NCT06230744

Conditions

Weight Loss

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Lifestyle

Lifestyle II

Study Details

Brief summary:

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 ID

NCT06230744

Start date

Sep 10, 2024

Status verified date

Jul, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Lifestyle Intervention

Diet and exercise coaching

experimental: Lifestyle Intervention II

Diet and exercise coaching

Interventions

Lifestyle

All participants will receive diet and exercise goals and coaching.

Lifestyle II

All participants will receive diet and exercise goals and coaching.

Primary outcome measure

  • Weight loss [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Olivia Hughes

7737022348bhughes8@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

UChicago IRB

773-702-6505

Principal Investigator:

Esra Tasali, MD

More Information

Sponsor

University of Chicago

Last update posted

Nov 17, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-11-17.