Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
Recruiting · NCT06745570 · Interventional (participants receive a specific treatment) · Lead sponsor: Nemours Children's Clinic
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Nemours Children's Clinic - Wilmington, Delaware, United States