- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02979860
Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligible families who provide consent/assent will be enrolled into a five week study. All families will complete assessments at baseline, two weeks and four weeks. Each assessment lasts one week and children will be asked to wear an actigraph on their wrist (to measure sleep) and an accelerometer on their hip (to measure physical activity). At the end of the week families will be scheduled for a visit at the research center first thing in the morning approximately one hour after waking and following an overnight fast. During this visit, actigraphs and accelerometers will be downloaded and data will be reviewed with families. Children will be weighed and measured for height and have their body composition assessed. To measure glucose regulation, children will first have 5 ml of blood drawn in a fasted state. They will then ingest a glucose solution (1.75 g/kg; maximum of 75 g) over 2 minutes, and blood will be drawn (1.5 ml) 120 min after the child consumes the solution. At week 4, 5 ml blood will be drawn fasting; OGTT will not be administered (see note below). Research staff will also complete one-day dietary recalls with participants at each center-based assessment to obtain information on all foods consumed over the previous 24-hour period. In addition, at the baseline assessment only, parents will complete questionnaires on basic demographic information and child sleep. It is anticipated that the total time for each assessment will take approximately 2.5-3 hours (1 hour at 4 weeks). Following eligibility confirmation at the baseline assessment, families will be randomized to one of four protocols: 1) Enhance TIB by 90 min/night; 2) Enhance TIB by 45 min/night; 3) Regularize Sleep Schedule; or 4) Typical Sleep Schedule.
Continuous glucose monitoring In a voluntary subset of randomly selected children (approximately n = 4/group) 72-hour continuous glucose monitoring (CGM) will be performed. If the child and family agree to participate in CGM, they will come to the Center for an additional visit during which a disposable subcutaneous glucose-sensing device connected to a battery-operated recorder will be inserted subcutaneously (a thin tube under the surface of the skin). This sensor measures glucose every ten seconds and records an average value every five minutes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Center for Obesity Research and Education, Temple University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parent-reported child race African American/Black.
- Parent-reported child age of 8-11 years
- Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy and sleep diaries)
- Variability in Sleep Patterns (based on actigraphy and sleep diaries)
- BMI for age and gender > 85th percentile (but no greater than 100% overweight)
- Self-reported parent age of 18 years, primary caretaker, and at home throughout the study (i.e., at bedtimes and wake times)
- Reported willingness to complete all study tasks, including blood draws
Exclusion Criteria:
- Diagnosable Sleep Disorder
- Parent-reported diagnosis of medical or psychiatric condition that may impact sleep/weight status
- Actively trying to lose weight
- Inability to Understand or Complete Protocol
- Sibling of enrolled subjects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Typical sleep schedule
Children in this arm will be asked to maintain their current sleep schedule.
No prescription will be provided other than to sleep how they "typically" would sleep.
|
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Experimental: Enhance time in bed by 90 min/night
Sleep duration - 90 minutes: Children in this arm will be asked to get into bed and to turn their lights out 90 minutes earlier than their typical bedtime.
Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.
|
Sleep duration: time in bed increased by 90 minutes
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Experimental: Enhance time in bed by 45 min/night
Sleep duration - 45 minutes:Children in this arm will be asked to get into bed and to turn their lights out 45 minutes earlier than their typical bedtime.
Bedtimes and wake times will remain consistent across the 4-week experimental phase of the study.
|
Sleep duration: time in bed increased by 45 minutes
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Experimental: Regularize sleep schedule
Sleep timing: Children in this arm will be asked to get into bed at a consistent bedtime each night and wake at a consistent time each morning such that time in bed achieved during baseline is maintained during the 4-week experimental phase; only timing of bedtimes/wake times will be manipulated in this arm.
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Sleep timing: bed time kept consistent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insulin Resistance
Time Frame: 4 weeks
|
Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic Measures
Time Frame: 3 3-hour assessment visits
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Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.
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3 3-hour assessment visits
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometrics
Time Frame: 3 3-hour assessment visits
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Child weight will be obtained on a digital scale and height on a wall-mounted stadiometer using standard procedures and while in street clothes, without shoes.
Measures will be converted to BMI, BMIz, and BMI percentile using age and sex-adjusted normative data from the CDC.
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3 3-hour assessment visits
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Body Composition
Time Frame: 3 3-hour assessment visits
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Youth body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA).
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3 3-hour assessment visits
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Acceptability/Feasibility
Time Frame: 2 3-hour assesment Visit
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Acceptability and feasibility of each experimental approach for changing sleep will be assessed with semi-structured qualitative interviews.
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2 3-hour assesment Visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chantelle Hart, PhD, Temple University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Respiratory System Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Oxymetazoline
Other Study ID Numbers
- 24131
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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