Sleep, Nutrition and Psychological Functioning in Kindergarten Children

Not Applicable

Completed

• Conditions: Prevention Harmful Effects
• Interventions: Behavioral: Healthy Nutrition intervention; Behavioral: Healthy Sleep intervention

• Registration Number: NCT02069249
• Lead Sponsor: Tel Aviv University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-24
• Study Start: 2014-03
• Primary Completion: 2018-11
• Study Completion: 2019-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Nutrition Intervention	Healthy Nutrition intervention	Healthy Nutrition Intervention (HNI)
Healthy Sleep Intervention	Healthy Sleep intervention	Healthy Sleep Intervention (HSI)

Primary Outcome Measures

Name	Time	Method
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
Change in parent reported sleep problems (BCSQ)	1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems	1 week post intervention, 6 month follow up
Change in parent reported nutrition habits of the child and family	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)	1 week post intervention, 6 month follow up

Secondary Outcome Measures

Name	Time	Method
Change in child attention control abilities (computerized tests)	1 week post intervention, 6 month follow up
Change in child psychopathological symptoms (SDQ)	1 week post intervention, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)	1 week post intervention, 6 month follow up
Change in cry tolerance and limit setting abilities	1 week post intervention, 6 month follow up
Change in reported parental Authority (PAQ-R)	1 week post intervention, 6 month follow up

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel