Clinical trial NCT02069249: Sleep, Nutrition and Psychological Functioning in Kindergarten Children
Official title: Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention Harmful Effects
Keywords: Preschool children
Sleep problems
Nutrition problems
Online intervention
Psychological functioning
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
Collaborators: name: Israel Science Foundation
First posted: 2014-02-24
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
timeFrame: Baseline, 1 week post-intervention
measure: Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
timeFrame: Baseline, 6-month follow up
measure: Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
timeFrame: 1 week post-intervention, 6 month follow up
measure: Change in parent reported sleep problems (BCSQ)
timeFrame: Baseline, 1 week post-intervention
measure: Change in parent reported sleep problems (BCSQ)
timeFrame: baseline, 6 month follow up
measure: Change in parent reported sleep problems (BCSQ)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
timeFrame: Baseline, 1 week post intervention
measure: Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
timeFrame: Baseline, 6 month follow up
measure: Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in child reported sleep and eating problems
timeFrame: Baseline, 1 week post intervention
measure: Change in child reported sleep and eating problems
timeFrame: Baseline, 6 month follow up
measure: Change in child reported sleep and eating problems
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in parent reported nutrition habits of the child and family
timeFrame: Baseline, 1 week post intervention
measure: Change in parent reported nutrition habits of the child and family
timeFrame: Baseline, 6 month follow up
measure: Change in parent reported nutrition habits of the child and family
timeFrame: 1 week post intervention, 6 month follow up
Secondary outcomes:
measure: Change in child psychopathological symptoms (SDQ)
timeFrame: Baseline, 1 week post intervention
measure: Change in child psychopathological symptoms (SDQ)
timeFrame: Baseline, 6 month follow up
measure: Change in child psychopathological symptoms (SDQ)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in child attention control abilities (computerized tests)
timeFrame: Baseline, 1 week post intervention
measure: Change in child attention control abilities (computerized tests)
timeFrame: Baseline, 6 month follow up
measure: Change in child attention control abilities (computerized tests)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in child anthropometric measures (height, weight, blood pressure)
timeFrame: Baseline, 1 week post intervention
measure: Change in child anthropometric measures (height, weight, blood pressure)
timeFrame: Baseline, 6 month follow up
measure: Change in child anthropometric measures (height, weight, blood pressure)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in reported parental Authority (PAQ-R)
timeFrame: Baseline, 1 week post intervention
measure: Change in reported parental Authority (PAQ-R)
timeFrame: Baseline, 6 month follow up
measure: Change in reported parental Authority (PAQ-R)
timeFrame: 1 week post intervention, 6 month follow up
measure: Change in cry tolerance and limit setting abilities
timeFrame: Baseline, 1 week post intervention
measure: Change in cry tolerance and limit setting abilities
timeFrame: Baseline, 6 month follow up
measure: Change in cry tolerance and limit setting abilities
timeFrame: 1 week post intervention, 6 month follow up
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
affiliation: Tel Aviv University
name: Avi Sadeh, Ds.c.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Geila Rozen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Ron Shaoul, M.D.
role: PRINCIPAL_INVESTIGATOR
References: