Sleep, Nutrition and Psychological Functioning in Kindergarten Children
2020년 3월 10일 업데이트: Michal Kahn, Tel Aviv University
Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study
The proposed study has the following aims: (a) to assess the concomitant and longitudinal links between sleep and cognitive, behavioral and emotional functioning in kindergarten children; (b) to assess the immediate and the long-term effects of an intervention to promote healthy sleep habits (HSI) on the child's evolving sleep patterns, as well as on related cognitive, behavioral and health domains; (c) to assess the immediate and the long-term effects of an intervention deigned to promote healthy nutrition (HNI) on the eating habits of children, their weight and BMI measures (the comparison/control group) and (d) to assess the links between eating habits and sleep in kindergarten children.
The main hypotheses of the proposed study are: (a) Shorter and more disrupted sleep would be concomitantly and longitudinally associated with compromised cognitive, emotional and behavioral functioning in kindergarten children; (b) In comparison to the HNI group, children in the HSI group will extend their total sleep time, improve their sleep quality and their sleep schedule will be more stable following the intervention; (c) improvement in sleep habits will be associated with improvement in cognitive, emotional and behavioral functioning; (d) in comparison to the HIS group, children in the HNI group will improve their eating habits, engage in more physical activities and better manage to achieve and maintain an age-appropriate body weight.
연구 개요
연구 유형
중재적
등록 (실제)
140
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Tel Aviv, 이스라엘, 69978
- Tel Aviv University
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Preschool children (aged 3-6 years) and their parents
Exclusion Criteria:
- (a) significant health or neurological-developmental problems; (b) severe psychological problems, psychiatric diagnosis or treatment; (c) concurrent psychotherapy or similar interventions; (d) medical sleep problems (e.g., sleep apnea); (e) lack of mastery in Hebrew.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Healthy Nutrition Intervention
Healthy Nutrition Intervention (HNI)
|
Healthy Nutrition Intervention (HNI)- This online system will include information for parents on the following issues: (a) increasing awareness and making healthy food choices; (b) increasing appeal of healthy food by games, rewards, and child involvement in preparation and cooking; (c) setting rules regarding proper eating environment, family meals and schedules; (d) limiting the presence of unhealthy food and beverage temptations at home; (e) limiting TV and other screen time and increasing physical activities; (f) encouraging parents to be positive role models for all these principles.
|
|
실험적: Healthy Sleep Intervention
Healthy Sleep Intervention (HSI)
|
Healthy Sleep Intervention (HSI)- This online interactive e-learning system will include information for parents on the following topics: (a) establishing appropriate bedtime, including how to assess the sleep needs of their child, how to establish regular bedtime and overall sleep schedule, how to deal with daytime naps; (b) establishing a regular and enjoyable bedtime routine (e.g.
bedtime stories); (c) coping with bedtime resistance, setting limits to excessive demands, rewarding appropriate sleep related behaviors; (d) coping with bedtime and nighttime fears, strategies to deal with separation anxieties, fears of darkness, scary imaginative creatures etc; (e) coping with excessive night-wakings and eliminating potential reinforcing consequences; (f) coping with nightmares, night terrors and other parasomnias (e.g., night-walking).
|
|
간섭 없음: Waiting list control
Waiting list control group
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
기간: Baseline, 1 week post-intervention
|
Baseline, 1 week post-intervention
|
|
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
기간: Baseline, 6-month follow up
|
Baseline, 6-month follow up
|
|
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
기간: 1 week post-intervention, 6 month follow up
|
1 week post-intervention, 6 month follow up
|
|
Change in parent reported sleep problems (BCSQ)
기간: Baseline, 1 week post-intervention
|
Baseline, 1 week post-intervention
|
|
Change in parent reported sleep problems (BCSQ)
기간: baseline, 6 month follow up
|
baseline, 6 month follow up
|
|
Change in parent reported sleep problems (BCSQ)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in child reported sleep and eating problems
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in child reported sleep and eating problems
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in child reported sleep and eating problems
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in parent reported nutrition habits of the child and family
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in parent reported nutrition habits of the child and family
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in parent reported nutrition habits of the child and family
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in child psychopathological symptoms (SDQ)
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in child psychopathological symptoms (SDQ)
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in child psychopathological symptoms (SDQ)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in child attention control abilities (computerized tests)
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in child attention control abilities (computerized tests)
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in child attention control abilities (computerized tests)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in child anthropometric measures (height, weight, blood pressure)
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in child anthropometric measures (height, weight, blood pressure)
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in child anthropometric measures (height, weight, blood pressure)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in reported parental Authority (PAQ-R)
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in reported parental Authority (PAQ-R)
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in reported parental Authority (PAQ-R)
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
|
Change in cry tolerance and limit setting abilities
기간: Baseline, 1 week post intervention
|
Baseline, 1 week post intervention
|
|
Change in cry tolerance and limit setting abilities
기간: Baseline, 6 month follow up
|
Baseline, 6 month follow up
|
|
Change in cry tolerance and limit setting abilities
기간: 1 week post intervention, 6 month follow up
|
1 week post intervention, 6 month follow up
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Avi Sadeh, Ds.c., Tel Aviv University
- 수석 연구원: Geila Rozen, PhD, Rambam Health Care Campus
- 수석 연구원: Ron Shaoul, M.D., Rambam Health Care Campus
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2014년 3월 1일
기본 완료 (실제)
2018년 11월 1일
연구 완료 (실제)
2019년 12월 1일
연구 등록 날짜
최초 제출
2014년 2월 16일
QC 기준을 충족하는 최초 제출
2014년 2월 19일
처음 게시됨 (추정)
2014년 2월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 10일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RMB-0425-13
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
예방 유해 효과에 대한 임상 시험
-
Near East University, TurkeyAl-Ahli Hospital, Hebron모집하지 않고 적극적으로DVT 예방 | DVT - 심부 정맥 혈전증 | 심장 온펌프 수술 | DVT 예방 | On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications | 간호 관리 프로토콜키프로스
Healthy Nutrition intervention에 대한 임상 시험
-
Rutgers, The State University of New Jersey완전한
-
Massachusetts General HospitalALS Association완전한
-
Imperial College London아직 모집하지 않음
-
University of California, San DiegoFamily Health Centers of San Diego; UCSD Center for Community Health완전한
-
Karolinska InstitutetSwedish Council for Working Life and Social Research; The Kamprad Family Foundation for...완전한