Adolescent OverweightSTARNCT06745570
Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity
A study testing Lifestyle Modification and Sleep Intervention in people with Adolescent Overweight and Adolescent Obesity, run by Nemours Children's Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Adolescent Overweight, Adolescent Obesity, Sleep
- What is being tested?
- Lifestyle Modification and Sleep Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nemours Children's Clinic
Wilmington, Delaware, 19803
Stephanie Manasse, Ph.D., (215) 553-7500, wellteen@drexel.edu
About this study
Official title: Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity
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.
Read the detailed description
In this study, the investigators will develop, refine, and test a 16-session group-based lifestyle modification intervention for adolescents with overweight and obesity augmented with a sleep intervention. The investigators will develop the manual and pilot the intervention in an initial set of adolescents (n=10). The investigators will collect feedback from adolescents, parents, and clinicians, which will inform manual refinements. The investigators will complete an open trial (n=40) of the refined manual. For both phases, the investigators will recruit adolescents (ages 14-18) with overweight or obesity who endorse at least 1 type of sleep disturbance (i.e., too little, poor quality, poorly timed, or inconsistent sleep). Assessments of sleep, decision-making, problematic eating behaviors, energy intake, and weight will occur at baseline (week 0), mid-intervention (week 8) and post-intervention (week 16).
- Being tested
- Lifestyle Modification and Sleep Intervention
- Keywords
- Adolescent Weight Loss, Adolescent Sleep, Adolescent Eating
- Medical subject headings
- Pediatric Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Modification and Sleep InterventionBehavioural
This study is being performed to develop, refine, and test the effects of a group lifestyle modification intervention augmented with a sleep intervention on weight loss, eating behaviors, and sleep outcomes. Results from this study will inform future studies to test the efficacy of this intervention. This intervention is being offered as part of a research study within Drexel University's WELL Center. Participants will receive remote, group-based, weekly weight loss and sleep coaching (90 minutes per coaching session) for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention | Experimental | All participants will receive group-based lifestyle modification and sleep treatment (16, 90-minute sessions over 16 weeks). All sessions will be delivered on Zoom (remotely) to small groups (n=5-10 each) of participants. The intervention involves lifestyle modification content (e.g., nutritional education, physical activity education, stimulus control, goal setting) and sleep content (e.g., psychoeducation regarding sleep and eating behavior, sleep tracking, establishing regular sleep-wake times). Receives: Behavioral: Lifestyle Modification and Sleep Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of 95th percentile BMI
Height and weight will be measured at each assessment and used to calculate percent of 95th percentile BMI.
Measured: From enrollment to the end of the study (approximately 4 months)
Tri-ponderal mass index
The investigators will also calculate tri-ponderal mass index (TMI; i.e., mass divided by height cubed) from measurements of height and weight.
Measured: From enrollment to the end of the study (approximately 4 months)
Body fat percentage
Body fat percentage will also be derived from the Aria Air scale.
Measured: From enrollment to the end of the study (approximately 4 months)
Secondary outcomes (11)
Dietary intake
Adolescent dietary intake will be assessed via 30-day dietary recalls using the VioScreen at the baseline and post-treatment assessments. This freely available and validated web-based tool enables automated, self-administered, 30-day recalls. The VioScreen provides item-level nutritional information as well as monthly totals of key nutrient variables. Mean intake of the following food/macronutrient groups will be calculated: fruits and vegetables, fat, saturated fat, protein, cholesterol, added sugars, and dietary fiber.
Measured: From enrollment to the end of the study (approximately 4 months)
Eating Disorder Examination
The investigators will also assess adolescent eating behaviors using the Binge Module and the Compensatory Behaviors Module portions of the Eating Disorder Examination at each assessment point.
Measured: From enrollment to the end of the study (approximately 4 months)
Eating Disorder Examination Questionnaire
The investigators will have adolescents and their parents complete the Eating Disorder Examination Questionnaire, a self-report measure of eating behaviors, and baseline and post-treatment.
Measured: From enrollment to the end of the study (approximately 4 months)
Average total sleep time
Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average total sleep time will be calculated.
Measured: From enrollment to the end of the study (approximately 4 months)
Average bed time
Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average bed time will be calculated.
Measured: From enrollment to the end of the study (approximately 4 months)
Average sleep latency
Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average sleep latency will be calculated.
Measured: From enrollment to the end of the study (approximately 4 months)
Average weekday-weekend bed time shift
Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average weekday-weekend bed time shift will be calculated.
Measured: From enrollment to the end of the study (approximately 4 months)
Pittsburgh Sleep Quality Index
Adolescents and their parents will complete the Pittsburgh Sleep Quality Index, a well-validated overall measure of sleep quality, at each assessment point.
Measured: From enrollment to the end of the study (approximately 4 months)
Morningness Eveningness Questionnaire
The investigators will use the Morningness Eveningness Questionnaire at each assessment point to assess differences in the degree to which adolescents are active and alert at certain times of the day.
Measured: From enrollment to the end of the study (approximately 4 months)
Insomnia Severity Index
The investigators will have participants complete the Insomnia Severity Index to assess insomnia.
Measured: From enrollment to the end of the study (approximately 4 months)
Sleep - Fitbit data
Participants will wear a FitBit during the assessment weeks, which will gather accelerometry data on sleep.
Measured: From enrollment to the end of the study (approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start18 Apr 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Manasse, Nemours Children's Clinic
- Investigators
- Stephanie Manasse, Ph.D., Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745570
- Sponsor's protocol ID
- 2310010117
- Other IDs
- R03DK138216
- Acronym
- STAR
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT06745570
- Acronym / sponsor ID
- STAR / 2310010117
- Keywords
- Adolescent Weight Loss, Adolescent Sleep, Adolescent Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, the investigators will develop, refine, and test a 16-session group-based lifestyle modification intervention for adolescents with overweight and obesity augmented with a sleep intervention. The investigators will develop the manual and pilot the intervention in an initial set of adolescents (n=10). The investigators will collect feedback from adolescents, parents, and clinicians, which will inform manual refinements. The investigators will complete an open trial (n=40) of the refined manual. For both phases, the investigators will recruit adolescents (ages 14-18) with overweight or obesity who endorse at least 1 type of sleep disturbance (i.e., too little, poor quality, poorly timed, or inconsistent sleep). Assessments of sleep, decision-making, problematic eating behaviors, energy intake, and weight will occur at baseline (week 0), mid-intervention (week 8) and post-intervention (week 16).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Intervention | Experimental | Behavioral: Lifestyle Modification and Sleep InterventionAll participants will receive group-based lifestyle modification and sleep treatment (16, 90-minute sessions over 16 weeks). All sessions will be delivered on Zoom (remotely) to small groups (n=5-10 each) of participants. The intervention involves lifestyle modification content (e.g., nutritional education, physical activity education, stimulus control, goal setting) and sleep content (e.g., psychoeducation regarding sleep and eating behavior, sleep tracking, establishing regular sleep-wake times). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Modification and Sleep InterventionThis study is being performed to develop, refine, and test the effects of a group lifestyle modification intervention augmented with a sleep intervention on weight loss, eating behaviors, and sleep outcomes. Results from this study will inform future studies to test the efficacy of this intervention. This intervention is being offered as part of a research study within Drexel University's WELL Center. Participants will receive remote, group-based, weekly weight loss and sleep coaching (90 minutes per coaching session) for 16 weeks. | Behavioural | Group Intervention |
Primary outcome
Percent of 95th percentile BMI
Time frame: From 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 index
Time frame: From 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 percentage
Time frame: From enrollment to the end of the study (approximately 4 months)
Body fat percentage will also be derived from the Aria Air scale.
11 secondary outcomes
Dietary intake
Time frame: From enrollment to the end of the study (approximately 4 months)
Eating Disorder Examination
Time frame: From enrollment to the end of the study (approximately 4 months)
Eating Disorder Examination Questionnaire
Time frame: From enrollment to the end of the study (approximately 4 months)
Average total sleep time
Time frame: From enrollment to the end of the study (approximately 4 months)
Average bed time
Time frame: From enrollment to the end of the study (approximately 4 months)
Average sleep latency
Time frame: From enrollment to the end of the study (approximately 4 months)
Average weekday-weekend bed time shift
Time frame: From enrollment to the end of the study (approximately 4 months)
Pittsburgh Sleep Quality Index
Time frame: From enrollment to the end of the study (approximately 4 months)
Morningness Eveningness Questionnaire
Time frame: From enrollment to the end of the study (approximately 4 months)
Insomnia Severity Index
Time frame: From enrollment to the end of the study (approximately 4 months)
Sleep - Fitbit data
Time frame: From enrollment to the end of the study (approximately 4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Manasse, Ph.D. principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Modification and Sleep Intervention in people with Adolescent Overweight and Adolescent Obesity, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Manasse, Ph.D (3022988390, aspirelab@nemours.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of 95th percentile BMI (time frame: From enrollment to the end of the study (approximately 4 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.