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Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk

22 de outubro de 2021 atualizado por: Temple University
Enhancing children's sleep duration and/or timing may represent a novel approach for weight regulation and prevention of T2DM. The proposed study will assess how experimental changes in children's sleep duration and timing affect weight regulation and T2DM risk. Sixty African American children ages 8-11 years old who sleep approximately 9.5 hours or less each night will be enrolled into a 4-arm randomized controlled pilot to compare three experimental manipulations in children's sleep to a "typical sleep" (TYP) control. Experimental arms will include: 1) increase in time in bed (TIB) by 90 minutes/night; 2) increase in TIB by 45 minutes/night; or 3) consistent (CON) sleep schedule (but no change in TIB). At baseline, 2- and 4-week follow-up, participants be weighed and measured for height, have body fat assessed (bod pod), and their blood drawn (following an overnight fast). The pilot will provide important data on the potential role of sleep in combating disparities in cardiometabolic risk. Primary aims are: 1) to determine the effects of changes in sleep on changes in glucose regulation and 2) to determine the effect of changes in sleep on additional measures of glucose regulation and adiposity.

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19140
        • Center for Obesity Research and Education, Temple University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

8 anos a 11 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Parent-reported child race African American/Black.
  2. Parent-reported child age of 8-11 years
  3. Less than or equal to approximately 9.5 hours time in bed (TIB; based on actigraphy and sleep diaries)
  4. Variability in Sleep Patterns (based on actigraphy and sleep diaries)
  5. BMI for age and gender > 85th percentile (but no greater than 100% overweight)
  6. Self-reported parent age of 18 years, primary caretaker, and at home throughout the study (i.e., at bedtimes and wake times)
  7. Reported willingness to complete all study tasks, including blood draws

Exclusion Criteria:

  1. Diagnosable Sleep Disorder
  2. Parent-reported diagnosis of medical or psychiatric condition that may impact sleep/weight status
  3. Actively trying to lose weight
  4. Inability to Understand or Complete Protocol
  5. Sibling of enrolled subjects

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
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
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
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.
Sleep timing: bed time kept consistent

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Insulin Resistance
Prazo: 4 weeks
Fasting plasma insulin and glucose will be used to compute the homeostatic model assessment of insulin resistance (HOMA-IR).
4 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Metabolic Measures
Prazo: 3 3-hour assessment visits
Blood will be drawn before and after the consumption of a glucose solution to compute an Insulin Sensitivity Index (ISI) and glucose tolerance.
3 3-hour assessment visits

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Anthropometrics
Prazo: 3 3-hour assessment visits
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.
3 3-hour assessment visits
Body Composition
Prazo: 3 3-hour assessment visits
Youth body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA).
3 3-hour assessment visits
Acceptability/Feasibility
Prazo: 2 3-hour assesment Visit
Acceptability and feasibility of each experimental approach for changing sleep will be assessed with semi-structured qualitative interviews.
2 3-hour assesment Visit

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Chantelle Hart, PhD, Temple University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de julho de 2017

Conclusão Primária (Real)

8 de abril de 2021

Conclusão do estudo (Real)

30 de junho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

29 de novembro de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de novembro de 2016

Primeira postagem (Estimativa)

2 de dezembro de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de outubro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de outubro de 2021

Última verificação

1 de outubro de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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