Improving Sleep, Weight, and Eating in Teens With Obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will pilot and refine a 16-session, group-based intervention that combines lifestyle modification with a sleep component for adolescents aged 14–18 who are overweight or obese and have at least one sleep disturbance. The study has two phases: an initial small pilot to develop the manual with 10 participants, followed by an open trial with 40 participants to test the refined program. Participants will receive weekly remote coaching for 16 weeks and complete assessments at baseline, week 8, and week 16, including daily sleep diaries during three 7-day periods at each assessment. Outcomes will include weight, sleep quality and timing, eating behaviors, and dietary intake. Eligible participants must have a BMI at or above the 85th percentile, English fluency, a participating parent/guardian, and at least one sleep disturbance; several exclusions related to recent weight loss or medications apply.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ages 14-18
* 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 it's running

• Nemours Children's Clinic
  Wilmington, Delaware, United States Recruiting

Study contacts

• Principal investigator: Stephanie Manasse, Ph.D. — Nemours Children's Clinic
• Study coordinator: Stephanie Manasse, Ph.D
• Email: aspirelab@nemours.org
• Phone: 3022988390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.