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Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity

This study is testing a group-based program called "Lifestyle Modification and Sleep Intervention" for adolescents (14-18 years old) who are overweight or have obesity and also experience sleep problems. The program aims to help with weight loss, healthy eating habits, and better sleep. Researchers want to see how this intervention affects your body mass index (BMI), body fat, and eating behaviors over about 4 months. To join, you need to be 14-18 years old, speak English, have a BMI at or above the 85th percentile for your age and sex, have a parent or guardian who can participate, and have at least one sleep disturbance. The study is currently recruiting 50 participants.

Study design
This is an interventional study with 50 planned participants. It involves developing and testing a group-based lifestyle and sleep intervention.
What's involved
You would participate in remote, weekly group coaching for 16 weeks. You would also complete assessments at the beginning, middle, and end of the intervention, including daily sleep diaries for three 7-day periods at each assessment.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured from enrollment to the end of the study, which is approximately 4 months.

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NCT06745570

Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity

Recruiting
NAAges 14–18InterventionalTreatment
Nemours Children's Clinic
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Lifestyle Modification and Sleep Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of 95th percentile BMI
Measured over From enrollment to the end of the study (approximately 4 months)
+2 more outcomes measured

Conditions

Adolescent Overweight
Adolescent Obesity
Sleep
Eating Behaviors
Dietary Intake

Explore related trials

ObesitySleep Disorder

Where it's being run

1 sites across 1 states
Delaware1

Study leadership

  • Stephanie Manasse, Ph.D. · PRINCIPAL_INVESTIGATOR · Nemours Children's Clinic

Who to contact

Stephanie Manasse, Ph.D
[email protected]
3022988390
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Percent of 95th percentile BMIFrom 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 indexFrom 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 percentageFrom enrollment to the end of the study (approximately 4 months)

    Body fat percentage will also be derived from the Aria Air scale.