NCT06230744

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Aug 2028

First Submitted

Initial submission to the registry

January 19, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

September 10, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

November 17, 2025

Status Verified

July 1, 2025

Enrollment Period

4 years

First QC Date

January 19, 2024

Last Update Submit

November 14, 2025

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Change in weight \[kg\] at 6 months. Weight will be measured by research staff during each visit in the morning in duplicate in the fasted state after voiding using calibrated digital scales, wearing a hospital gown.

    Baseline and 6 months

Study Arms (2)

Lifestyle Intervention

OTHER

Diet and exercise coaching

Behavioral: Lifestyle

Lifestyle Intervention II

EXPERIMENTAL

Diet and exercise coaching

Behavioral: Lifestyle II

Interventions

LifestyleBEHAVIORAL

All participants will receive diet and exercise goals and coaching.

Lifestyle Intervention
Lifestyle IIBEHAVIORAL

All participants will receive diet and exercise goals and coaching.

Lifestyle Intervention II

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Esra Tasali, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Hughes

CONTACT

7737022348bhughes8@bsd.uchicago.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2024

First Posted

January 30, 2024

Study Start

September 10, 2024

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

November 17, 2025

Record last verified: 2025-07

Locations

US(1)