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Sleep, Nutrition and Psychological Functioning in Kindergarten Children

This study is currently recruiting participants.
Verified April 2017 by Michal Kahn, Tel Aviv University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02069249
First Posted: February 24, 2014
Last Update Posted: May 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Israel Science Foundation
Information provided by (Responsible Party):
Michal Kahn, Tel Aviv University
  Purpose

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.


Condition Intervention
Prevention Harmful Effects Behavioral: Healthy Sleep intervention Behavioral: Healthy Nutrition intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study

Further study details as provided by Michal Kahn, Tel Aviv University:

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

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

Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069249


Contacts
Contact: Avi Sadeh, D.Sc. 972-3-6409296 sadeh@post.tau.ac.il

Locations
Israel
Tel Aviv University Recruiting
Tel Aviv, Israel, 69978
Principal Investigator: Avi Sadeh, Ds.c.         
Sub-Investigator: Michal Kahn, M.A.         
Sub-Investigator: Ortal Schnabel, M.A.         
Sponsors and Collaborators
Tel Aviv University
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
  More Information

Responsible Party: Michal Kahn, PhD student, Laboratory for Children's Sleep-Wake Disorders, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02069249     History of Changes
Other Study ID Numbers: RMB-0425-13
First Submitted: February 16, 2014
First Posted: February 24, 2014
Last Update Posted: May 2, 2017
Last Verified: April 2017

Keywords provided by Michal Kahn, Tel Aviv University:
Preschool children
Sleep problems
Nutrition problems
Online intervention
Psychological functioning