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Completed

NCT Number: NCT02069249

Sleep, Nutrition and Psychological Functioning in Kindergarten Children

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv University

Tel Aviv, 69978, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Sleep Intervention

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures

    Time frame: Baseline, 1 week post-intervention

  2. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures

    Time frame: Baseline, 6-month follow up

  3. Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures

    Time frame: 1 week post-intervention, 6 month follow up

  4. Change in parent reported sleep problems (BCSQ)

    Time frame: Baseline, 1 week post-intervention

  5. Change in parent reported sleep problems (BCSQ)

    Time frame: baseline, 6 month follow up

  6. Change in parent reported sleep problems (BCSQ)

    Time frame: 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)

    Time frame: Baseline, 1 week post intervention

  8. Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)

    Time frame: Baseline, 6 month follow up

  9. Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)

    Time frame: 1 week post intervention, 6 month follow up

  10. Change in child reported sleep and eating problems

    Time frame: Baseline, 1 week post intervention

  11. Change in child reported sleep and eating problems

    Time frame: Baseline, 6 month follow up

  12. Change in child reported sleep and eating problems

    Time frame: 1 week post intervention, 6 month follow up

  13. Change in parent reported nutrition habits of the child and family

    Time frame: Baseline, 1 week post intervention

  14. Change in parent reported nutrition habits of the child and family

    Time frame: Baseline, 6 month follow up

  15. Change in parent reported nutrition habits of the child and family

    Time frame: 1 week post intervention, 6 month follow up

Secondary outcomes

  1. Change in child psychopathological symptoms (SDQ)

    Time frame: Baseline, 1 week post intervention

  2. Change in child psychopathological symptoms (SDQ)

    Time frame: Baseline, 6 month follow up

  3. Change in child psychopathological symptoms (SDQ)

    Time frame: 1 week post intervention, 6 month follow up

  4. Change in child attention control abilities (computerized tests)

    Time frame: Baseline, 1 week post intervention

  5. Change in child attention control abilities (computerized tests)

    Time frame: Baseline, 6 month follow up

  6. Change in child attention control abilities (computerized tests)

    Time frame: 1 week post intervention, 6 month follow up

  7. Change in child anthropometric measures (height, weight, blood pressure)

    Time frame: Baseline, 1 week post intervention

  8. Change in child anthropometric measures (height, weight, blood pressure)

    Time frame: Baseline, 6 month follow up

  9. Change in child anthropometric measures (height, weight, blood pressure)

    Time frame: 1 week post intervention, 6 month follow up

  10. Change in reported parental Authority (PAQ-R)

    Time frame: Baseline, 1 week post intervention

  11. Change in reported parental Authority (PAQ-R)

    Time frame: Baseline, 6 month follow up

  12. Change in reported parental Authority (PAQ-R)

    Time frame: 1 week post intervention, 6 month follow up

  13. Change in cry tolerance and limit setting abilities

    Time frame: Baseline, 1 week post intervention

  14. Change in cry tolerance and limit setting abilities

    Time frame: Baseline, 6 month follow up

  15. Change in cry tolerance and limit setting abilities

    Time frame: 1 week post intervention, 6 month follow up

Sponsors and collaborators

Lead sponsor

Tel Aviv University

Other

Collaborators

  • Israel Science Foundation

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2014
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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