- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02979860
Experimental Changes in Children's Sleep Duration and Timing: Effect on Obesity and Type 2 Diabetes Risk
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Center for Obesity Research and Education, Temple University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: 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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실험적: 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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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Insulin Resistance
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Metabolic Measures
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Anthropometrics
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Chantelle Hart, PhD, Temple University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24131
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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