Sleep, Nutrition and Psychological Functioning in Kindergarten Children

NCT02069249 | Completed

• 1 other identifier: RMB-0425-13
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prevention Harmful Effects

Keywords

Preschool children; Sleep problems; Nutrition problems; Online intervention; Psychological functioning

Outcome Measures

Primary Outcomes (15)

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

  Baseline, 1 week post-intervention

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

  Baseline, 6-month follow up

• 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

• Change in parent reported sleep problems (BCSQ)

  Baseline, 1 week post-intervention

• Change in parent reported sleep problems (BCSQ)

  baseline, 6 month follow up

• Change in parent reported sleep problems (BCSQ)

  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)

  Baseline, 1 week post intervention

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

  Baseline, 6 month follow up

• 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

• Change in child reported sleep and eating problems

  Baseline, 1 week post intervention

• Change in child reported sleep and eating problems

  Baseline, 6 month follow up

• Change in child reported sleep and eating problems

  1 week post intervention, 6 month follow up

• Change in parent reported nutrition habits of the child and family

  Baseline, 1 week post intervention

• Change in parent reported nutrition habits of the child and family

  Baseline, 6 month follow up

• Change in parent reported nutrition habits of the child and family

  1 week post intervention, 6 month follow up

Secondary Outcomes (15)

• Change in child psychopathological symptoms (SDQ)

  Baseline, 1 week post intervention

• Change in child psychopathological symptoms (SDQ)

  Baseline, 6 month follow up

• Change in child psychopathological symptoms (SDQ)

  1 week post intervention, 6 month follow up

• Change in child attention control abilities (computerized tests)

  Baseline, 1 week post intervention

• Change in child attention control abilities (computerized tests)

  Baseline, 6 month follow up

Study Arms (3)

Healthy Nutrition Intervention

EXPERIMENTAL

Healthy Nutrition Intervention (HNI)

Behavioral: Healthy Nutrition intervention

Healthy Sleep Intervention

EXPERIMENTAL

Healthy Sleep Intervention (HSI)

Behavioral: Healthy Sleep intervention

Waiting list control

NO INTERVENTION

Waiting list control group

Interventions

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 Sleep Intervention

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.

Healthy Nutrition Intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preschool children (aged 3-6 years) and their parents

You may not qualify if:

• (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.

Sponsors & Collaborators

• Tel Aviv University: lead
• Israel Science Foundation: collaborator

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Laboratory for Children's Sleep-Wake Disorders

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 24, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2019
• Last Updated: March 12, 2020

Record last verified: 2020-03

Locations

IL (1)