Prevention Harmful EffectsNCT02069249
Sleep, Nutrition and Psychological Functioning in Kindergarten Children
A study testing Healthy Sleep intervention and Healthy Nutrition intervention in people with Prevention Harmful Effects, run by Tel Aviv University at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Healthy Sleep intervention and Healthy Nutrition intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preschool children (aged 3-6 years) and their parents
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prevention Harmful Effects
- Being tested
- Healthy Sleep intervention, Healthy Nutrition intervention
- Keywords
- Preschool children, Sleep problems, Nutrition problems, Online intervention, Psychological functioning
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Sleep interventionBehavioural
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 interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Nutrition Intervention | Experimental | Healthy Nutrition Intervention (HNI) Receives: Behavioral: Healthy Nutrition intervention |
| Healthy Sleep Intervention | Experimental | Healthy Sleep Intervention (HSI) Receives: Behavioral: Healthy Sleep intervention |
| Waiting list control | No intervention | Waiting list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Measured: Baseline, 1 week post-intervention
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Measured: Baseline, 6-month follow up
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures
Measured: 1 week post-intervention, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Measured: Baseline, 1 week post-intervention
Change in parent reported sleep problems (BCSQ)
Measured: baseline, 6 month follow up
Change in parent reported sleep problems (BCSQ)
Measured: 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)
Measured: Baseline, 1 week post intervention
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Measured: Baseline, 6 month follow up
Change in parent reported child's sleeping and food consumption (derived from Daily sleep and nutrition logs)
Measured: 1 week post intervention, 6 month follow up
Change in child reported sleep and eating problems
Measured: Baseline, 1 week post intervention
Change in child reported sleep and eating problems
Measured: Baseline, 6 month follow up
Change in child reported sleep and eating problems
Measured: 1 week post intervention, 6 month follow up
Change in parent reported nutrition habits of the child and family
Measured: Baseline, 1 week post intervention
Change in parent reported nutrition habits of the child and family
Measured: Baseline, 6 month follow up
Change in parent reported nutrition habits of the child and family
Measured: 1 week post intervention, 6 month follow up
Secondary outcomes (15)
Change in child psychopathological symptoms (SDQ)
Measured: Baseline, 1 week post intervention
Change in child psychopathological symptoms (SDQ)
Measured: Baseline, 6 month follow up
Change in child psychopathological symptoms (SDQ)
Measured: 1 week post intervention, 6 month follow up
Change in child attention control abilities (computerized tests)
Measured: Baseline, 1 week post intervention
Change in child attention control abilities (computerized tests)
Measured: Baseline, 6 month follow up
Change in child attention control abilities (computerized tests)
Measured: 1 week post intervention, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Measured: Baseline, 1 week post intervention
Change in child anthropometric measures (height, weight, blood pressure)
Measured: Baseline, 6 month follow up
Change in child anthropometric measures (height, weight, blood pressure)
Measured: 1 week post intervention, 6 month follow up
Change in reported parental Authority (PAQ-R)
Measured: Baseline, 1 week post intervention
Change in reported parental Authority (PAQ-R)
Measured: Baseline, 6 month follow up
Change in reported parental Authority (PAQ-R)
Measured: 1 week post intervention, 6 month follow up
Change in cry tolerance and limit setting abilities
Measured: Baseline, 1 week post intervention
Change in cry tolerance and limit setting abilities
Measured: Baseline, 6 month follow up
Change in cry tolerance and limit setting abilities
Measured: 1 week post intervention, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention Harmful EffectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Israel Science Foundation
- Responsible party
- Principal investigator, Michal Kahn, Tel Aviv University
- Investigators
- Avi Sadeh, Ds.c., Principal investigator, Tel Aviv UniversityGeila Rozen, PhD, Principal investigator, Rambam Health Care CampusRon Shaoul, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069249
- Sponsor's protocol ID
- RMB-0425-13
- Status last verified
- Mar 2020
- First submitted
- 16 Feb 2014
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Nutrition and Psychological Functioning in Kindergarten Children: A Longitudinal Intervention Study
- ClinicalTrials.gov ID
- NCT02069249
- Acronym / sponsor ID
- RMB-0425-13
- Conditions
- Prevention Harmful Effects
- Keywords
- Preschool children, Sleep problems, Nutrition problems, Online intervention, Psychological functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Israel Science Foundation
- Study start
- Mar 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Nutrition Intervention | Experimental | Behavioral: Healthy Nutrition interventionHealthy Nutrition Intervention (HNI) |
| Healthy Sleep Intervention | Experimental | Behavioral: Healthy Sleep interventionHealthy Sleep Intervention (HSI) |
| Waiting list control | No intervention | –Waiting list control group |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preschool children (aged 3-6 years) and their parents
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Sleep interventionHealthy 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). | Behavioural | Healthy Sleep Intervention |
| Healthy Nutrition interventionHealthy 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. | Behavioural | Healthy Nutrition Intervention |
Primary outcome
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
15 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Sadeh, Ds.c. principal investigator
Tel Aviv University
Geila Rozen, PhD principal investigator
Rambam Health Care Campus
Ron Shaoul, M.D. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Sleep intervention and Healthy Nutrition intervention in people with Prevention Harmful Effects, run by Tel Aviv University at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in actigraphic sleep quality (e.g., number of night-wakings, sleep efficiency) and sleep quantity measures (time frame: Baseline, 1 week post-intervention). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2020.