Weight LossNCT06230744
A Novel Intervention for Weight Loss in Young Adults
A study testing Lifestyle and Lifestyle II in people with Weight Loss, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Lifestyle and Lifestyle II
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
UChicago IRB, 773-702-6505
Esra Tasali, MD
About this study
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?
Read the detailed description
The study team is seeking volunteers to participate in a research study to help better understand how a behavioral intervention combined with technology may impact weight loss. Participation will span approximately 6 months. Participants will be required to attend up to 5 visits at the University of Chicago. Those visits will include daytime visits to a clinic involving fasted blood draws and completion of surveys. During the study, participants will regularly record their weight using a digital scale, input their daily food intake into a smartphone app, and wear a wrist activity monitor to track their physical activity. Participants will also be paired with a trained coach to guide and assist their progress over their 6 months of participation.
- Conditions
- Weight Loss
- Being tested
- Lifestyle, Lifestyle II
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
All participants will receive diet and exercise goals and coaching.
Lifestyle IIBehavioural
All participants will receive diet and exercise goals and coaching.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Other | Diet and exercise coaching Receives: Behavioral: Lifestyle |
| Lifestyle Intervention II | Experimental | Diet and exercise coaching Receives: Behavioral: Lifestyle II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Sep 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230744
- Sponsor's protocol ID
- IRB23-1677
- Other IDs
- 1R01DK136214-01A1
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Intervention for Weight Loss in Young Adults
- ClinicalTrials.gov ID
- NCT06230744
- Acronym / sponsor ID
- IRB23-1677
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The study team is seeking volunteers to participate in a research study to help better understand how a behavioral intervention combined with technology may impact weight loss. Participation will span approximately 6 months. Participants will be required to attend up to 5 visits at the University of Chicago. Those visits will include daytime visits to a clinic involving fasted blood draws and completion of surveys. During the study, participants will regularly record their weight using a digital scale, input their daily food intake into a smartphone app, and wear a wrist activity monitor to track their physical activity. Participants will also be paired with a trained coach to guide and assist their progress over their 6 months of participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Other | Behavioral: LifestyleDiet and exercise coaching |
| Lifestyle Intervention II | Experimental | Behavioral: Lifestyle IIDiet and exercise coaching |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifestyleAll participants will receive diet and exercise goals and coaching. | Behavioural | Lifestyle Intervention |
| Lifestyle IIAll participants will receive diet and exercise goals and coaching. | Behavioural | Lifestyle Intervention II |
Primary outcome
Weight loss
Time frame: Baseline and 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esra Tasali, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle and Lifestyle II in people with Weight Loss, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Hughes (7737022348, bhughes8@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.