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NCT06745570
Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
Conditions: Adolescent Overweight, Adolescent Obesity, Sleep, Eating Behaviors, Dietary Intake
Sex: All
Ages: 14 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Nemours Children's Clinic
Location: Nemours Children's Clinic Wilmington Delaware
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06745570). StuddyBuddy aggregates publicly available trial information.