NCT06745570 · Nemours Children's Clinic
Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
(STAR)
What this study is about
This study is being performed to understand the effects of a lifestyle modification and sleep intervention on weight loss outcomes in adolescence.
View original scientific description
This study is being performed to understand the effects of a lifestyle modification and sleep intervention on weight loss outcomes in adolescence. The main question the study aims to answer is: \- What are the initial effects of a lifestyle modification and sleep intervention, including effects on weight, eating behaviors and dietary intake, and sleep? Participants will: * Participate in remote, group-based, weekly weight loss and sleep coaching for 16 weeks. * Complete study assessments at baseline (pre-intervention), mid-intervention, and post-intervention. * Complete daily sleep diaries for three 7-day periods at each assessment point.
Interventions
BEHAVIORAL
Lifestyle Modification and Sleep Intervention
This study is being performed to develop, refine, and test the effects of a group lifestyle modification intervention augmented with a sleep intervention on weight loss, eating behaviors, and sleep outcomes. Results from this study will inform future studies to test the efficacy of this intervention. This intervention is being offered as part of a research study within Drexel University's WELL Center. Participants will receive remote, group-based, weekly weight loss and sleep coaching (90 minutes per coaching session) for 16 weeks.
Primary outcome measures
Percent of 95th percentile BMI
Time frame: From enrollment to the end of the study (approximately 4 months)
Height and weight will be measured at each assessment and used to calculate percent of 95th percentile BMI.
Tri-ponderal mass index
Time frame: From enrollment to the end of the study (approximately 4 months)
The investigators will also calculate tri-ponderal mass index (TMI; i.e., mass divided by height cubed) from measurements of height and weight.
Body fat percentage
Time frame: From enrollment to the end of the study (approximately 4 months)
Body fat percentage will also be derived from the Aria Air scale.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Fluent in English
- BMI percentile ≥ 85th percentile for sex-and-age
- Has a parent or guardian who is willing and able to participate
- Has at least one sleep disturbance. Eligible sleep disturbances are: a. Advanced sleep timing (sleep onset 11:00pm or later for 14-16 year-olds or 11:20pm or later for 17-18 year-olds at least 3 times per week), b. Difficulty falling asleep (taking ≥ 30 mins to get to sleep 3 or more nights per week), c. Short sleep (obtaining \< 7.5 hours of sleep per night 3 or more nights per week), and d. Sleep irregularity (having more than 2 hours of variability in sleep-wake schedule across one week
Exclusion criteria
- Experience of weight loss of ≥ 5% of body weight in the past 6 months
- Current use of insomnia medication
- Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
- Currently taking weight loss medications
- Currently taking insulin
- Diagnosed diabetes (type 1)
- Any condition prohibiting physical activity
- Diagnosis of an eating disorder
- Diagnosis of obstructive sleep apnea
- Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
- Currently pregnant or less than 3 months postpartum
- Anticipation of a possible pregnancy in the next year
- Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial
- Currently participating in treatment for eating or weight concerns
- Does not have regular access to Wi-Fi connection to participate in study interventions.
Where
- Wilmington, Delaware
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 20, 2026 · Source of record for eligibility and locations