Sleep, Nutrition and Psychological Functioning in Kindergarten Children

Prevention Harmful Effects Clinical Trial

Official title:

Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069249
• Other study ID #: RMB-0425-13
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prevention Harmful Effects

Intervention

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).
• 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.

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel Aviv University	Israel Science Foundation

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures		Baseline, 1 week post-intervention
Primary	Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures		Baseline, 6-month follow up
Primary	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
Primary	Change in parent reported sleep problems (BCSQ)		Baseline, 1 week post-intervention
Primary	Change in parent reported sleep problems (BCSQ)		baseline, 6 month follow up
Primary	Change in parent reported sleep problems (BCSQ)		1 week post intervention, 6 month follow up
Primary	Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)		Baseline, 1 week post intervention
Primary	Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)		Baseline, 6 month follow up
Primary	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
Primary	Change in child reported sleep and eating problems		Baseline, 1 week post intervention
Primary	Change in child reported sleep and eating problems		Baseline, 6 month follow up
Primary	Change in child reported sleep and eating problems		1 week post intervention, 6 month follow up
Primary	Change in parent reported nutrition habits of the child and family		Baseline, 1 week post intervention
Primary	Change in parent reported nutrition habits of the child and family		Baseline, 6 month follow up
Primary	Change in parent reported nutrition habits of the child and family		1 week post intervention, 6 month follow up
Secondary	Change in child psychopathological symptoms (SDQ)		Baseline, 1 week post intervention
Secondary	Change in child psychopathological symptoms (SDQ)		Baseline, 6 month follow up
Secondary	Change in child psychopathological symptoms (SDQ)		1 week post intervention, 6 month follow up
Secondary	Change in child attention control abilities (computerized tests)		Baseline, 1 week post intervention
Secondary	Change in child attention control abilities (computerized tests)		Baseline, 6 month follow up
Secondary	Change in child attention control abilities (computerized tests)		1 week post intervention, 6 month follow up
Secondary	Change in child anthropometric measures (height, weight, blood pressure)		Baseline, 1 week post intervention
Secondary	Change in child anthropometric measures (height, weight, blood pressure)		Baseline, 6 month follow up
Secondary	Change in child anthropometric measures (height, weight, blood pressure)		1 week post intervention, 6 month follow up
Secondary	Change in reported parental Authority (PAQ-R)		Baseline, 1 week post intervention
Secondary	Change in reported parental Authority (PAQ-R)		Baseline, 6 month follow up
Secondary	Change in reported parental Authority (PAQ-R)		1 week post intervention, 6 month follow up
Secondary	Change in cry tolerance and limit setting abilities		Baseline, 1 week post intervention
Secondary	Change in cry tolerance and limit setting abilities		Baseline, 6 month follow up
Secondary	Change in cry tolerance and limit setting abilities		1 week post intervention, 6 month follow up