Sleep, Nutrition and Psychological Functioning in Kindergarten Children

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.

Study Overview

• Status: Completed
• Conditions: Prevention Harmful Effects
• Intervention / Treatment: Behavioral: Healthy Nutrition intervention; Behavioral: Healthy Sleep intervention

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69978
    • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures	Baseline, 1 week post-intervention
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures	Baseline, 6-month follow up
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)	Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)	baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)	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)	Baseline, 1 week post intervention
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)	Baseline, 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
Change in child reported sleep and eating problems	Baseline, 1 week post intervention
Change in child reported sleep and eating problems	Baseline, 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	Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family	Baseline, 6 month follow up
Change in parent reported nutrition habits of the child and family	1 week post intervention, 6 month follow up

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: February 16, 2014
• First Submitted That Met QC Criteria: February 19, 2014
• First Posted (Estimate): February 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Preschool children; Psychological functioning; Sleep problems; Nutrition problems; Online intervention
• Other Study ID Numbers: RMB-0425-13