NCT06745570Recruiting
Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity
Source: ClinicalTrials.gov · Last updated 20 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 9 Dec 2024
- Start date
- 18 Apr 2024
- Primary completion date
- 15 Jan 2027
- Lead sponsor
- Nemours Children's Clinic
- Diseases
- Obesity
- NCT number
- NCT06745570
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 18 Apr 2024 to the primary completion date, 15 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
Other illness
- Diagnosed diabetes (type 1)
- Any condition prohibiting physical activity
- Diagnosis of an eating disorder
Other
- Experience of weight loss of ≥ 5% of body weight in the past 6 months
- Diagnosis of obstructive sleep apnea
- 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.
Who the study is looking for
- 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
Age in the registry: 14 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nemours Children's Clinic Coordinator of this site? Confirm its status | Wilmington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.