No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
14 – 18
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Nemours Children's Clinic · Other
Who this trial is looking for
This trial is looking for teens aged 14-18 who struggle with obesity and sleep issues. Participants will join weekly coaching sessions for 16 weeks and track their sleep and eating habits.
Are You a Good Fit for This Trial?
Must not be takingInsomnia medication
Rules you outType 1 diabetesEating disorderObstructive sleep apnea
You may be able to join if
I am aged 14-18
I speak English fluently
My BMI is in the 85th percentile or higher for my age and sex
I have a parent or guardian who can participate
I have at least one sleep problem
You may not be able to join if
I have lost 5% or more of my body weight in the last 6 months
I currently use insomnia medication
I have diabetes (type 1)
I have been diagnosed with an eating disorder
I have a problem with drug or alcohol abuse
I am currently pregnant or less than 3 months postpartum
I am unwilling to report any pregnancies during the trial
I do not have regular access to Wi-Fi
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
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…
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.
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