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- Registre américain des essais cliniques
- Essai clinique NCT02979860
Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19140
- Center for Obesity Research and Education, Temple University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune 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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Expérimental: 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.
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Sleep duration: time in bed increased by 90 minutes
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Expérimental: 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.
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Sleep duration: time in bed increased by 45 minutes
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Insulin Resistance
Délai: 4 weeks
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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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Metabolic Measures
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Anthropometrics
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Chantelle Hart, PhD, Temple University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du métabolisme du glucose
- Maladies métaboliques
- Maladies du système endocrinien
- Diabète sucré
- Diabète sucré, Type 2
- Effets physiologiques des médicaments
- Agents adrénergiques
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Agents autonomes
- Agents du système nerveux périphérique
- Alpha-agonistes adrénergiques
- Agonistes adrénergiques
- Agents du système respiratoire
- Sympathomimétiques
- Agents vasoconstricteurs
- Décongestionnants nasaux
- Oxymétazoline
Autres numéros d'identification d'étude
- 24131
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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