Sleep, Nutrition and Psychological Functioning in Kindergarten Children

March 10, 2020 updated by: Michal Kahn, Tel Aviv University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Time Frame: Baseline, 1 week post-intervention
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
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
1 week post-intervention, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Time Frame: Baseline, 1 week post-intervention
Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)
Time Frame: baseline, 6 month follow up
baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Time Frame: 1 week post intervention, 6 month follow up
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
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
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
1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child reported sleep and eating problems
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child reported sleep and eating problems
Time Frame: 1 week post intervention, 6 month follow up
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
Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family
Time Frame: Baseline, 6 month follow up
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
1 week post intervention, 6 month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in child psychopathological symptoms (SDQ)
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child psychopathological symptoms (SDQ)
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child psychopathological symptoms (SDQ)
Time Frame: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child attention control abilities (computerized tests)
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child attention control abilities (computerized tests)
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child attention control abilities (computerized tests)
Time Frame: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in child anthropometric measures (height, weight, blood pressure)
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Time Frame: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in reported parental Authority (PAQ-R)
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in reported parental Authority (PAQ-R)
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in reported parental Authority (PAQ-R)
Time Frame: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up
Change in cry tolerance and limit setting abilities
Time Frame: Baseline, 1 week post intervention
Baseline, 1 week post intervention
Change in cry tolerance and limit setting abilities
Time Frame: Baseline, 6 month follow up
Baseline, 6 month follow up
Change in cry tolerance and limit setting abilities
Time Frame: 1 week post intervention, 6 month follow up
1 week post intervention, 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tel Aviv University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Israel Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMB-0425-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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