Sleep, Nutrition and Psychological Functioning in Kindergarten Children

Sponsor
Tel Aviv University (Other)
Overall Status
Completed
CT.gov ID
NCT02069249
Collaborator
Israel Science Foundation (Other)
140
1
3
69
2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Healthy Sleep intervention
  • Behavioral: Healthy Nutrition intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study
Actual Study Start Date :
Mar 1, 2014
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy Nutrition Intervention

Healthy Nutrition Intervention (HNI)

Behavioral: Healthy Nutrition intervention
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.

Experimental: Healthy Sleep Intervention

Healthy Sleep Intervention (HSI)

Behavioral: Healthy Sleep intervention
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).

No Intervention: Waiting list control

Waiting list control group

Outcome Measures

Primary Outcome Measures

  1. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures [Baseline, 1 week post-intervention]

  2. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures [Baseline, 6-month follow up]

  3. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures [1 week post-intervention, 6 month follow up]

  4. Change in parent reported sleep problems (BCSQ) [Baseline, 1 week post-intervention]

  5. Change in parent reported sleep problems (BCSQ) [baseline, 6 month follow up]

  6. Change in parent reported sleep problems (BCSQ) [1 week post intervention, 6 month follow up]

  7. Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs) [Baseline, 1 week post intervention]

  8. Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs) [Baseline, 6 month follow up]

  9. Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs) [1 week post intervention, 6 month follow up]

  10. Change in child reported sleep and eating problems [Baseline, 1 week post intervention]

  11. Change in child reported sleep and eating problems [Baseline, 6 month follow up]

  12. Change in child reported sleep and eating problems [1 week post intervention, 6 month follow up]

  13. Change in parent reported nutrition habits of the child and family [Baseline, 1 week post intervention]

  14. Change in parent reported nutrition habits of the child and family [Baseline, 6 month follow up]

  15. Change in parent reported nutrition habits of the child and family [1 week post intervention, 6 month follow up]

Secondary Outcome Measures

  1. Change in child psychopathological symptoms (SDQ) [Baseline, 1 week post intervention]

  2. Change in child psychopathological symptoms (SDQ) [Baseline, 6 month follow up]

  3. Change in child psychopathological symptoms (SDQ) [1 week post intervention, 6 month follow up]

  4. Change in child attention control abilities (computerized tests) [Baseline, 1 week post intervention]

  5. Change in child attention control abilities (computerized tests) [Baseline, 6 month follow up]

  6. Change in child attention control abilities (computerized tests) [1 week post intervention, 6 month follow up]

  7. Change in child anthropometric measures (height, weight, blood pressure) [Baseline, 1 week post intervention]

  8. Change in child anthropometric measures (height, weight, blood pressure) [Baseline, 6 month follow up]

  9. Change in child anthropometric measures (height, weight, blood pressure) [1 week post intervention, 6 month follow up]

  10. Change in reported parental Authority (PAQ-R) [Baseline, 1 week post intervention]

  11. Change in reported parental Authority (PAQ-R) [Baseline, 6 month follow up]

  12. Change in reported parental Authority (PAQ-R) [1 week post intervention, 6 month follow up]

  13. Change in cry tolerance and limit setting abilities [Baseline, 1 week post intervention]

  14. Change in cry tolerance and limit setting abilities [Baseline, 6 month follow up]

  15. Change in cry tolerance and limit setting abilities [1 week post intervention, 6 month follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tel Aviv University Tel Aviv Israel 69978

Sponsors and Collaborators

  • Tel Aviv University
  • Israel Science Foundation

Investigators

  • Principal Investigator: Avi Sadeh, Ds.c., Tel Aviv University
  • Principal Investigator: Geila Rozen, PhD, Rambam Health Care Campus
  • Principal Investigator: Ron Shaoul, M.D., Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michal Kahn, PhD student, Laboratory for Children's Sleep-Wake Disorders, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT02069249
Other Study ID Numbers:
  • RMB-0425-13
First Posted:
Feb 24, 2014
Last Update Posted:
Mar 12, 2020
Last Verified:
Mar 1, 2020
Keywords provided by Michal Kahn, PhD student, Laboratory for Children's Sleep-Wake Disorders, Tel Aviv University

Study Results

No Results Posted as of Mar 12, 2020