Sleep, Nutrition and Psychological Functioning in Kindergarten Children

NCT ID: NCT02069249

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Nutrition Intervention

Healthy Nutrition Intervention (HNI)

Group Type: EXPERIMENTAL

Healthy Nutrition intervention

Intervention Type: 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 Sleep Intervention

Healthy Sleep Intervention (HSI)

Group Type: EXPERIMENTAL

Healthy Sleep intervention

Intervention Type: 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).

Waiting list control

Waiting list control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Israel Science Foundation

OTHER

Sponsor Role: collaborator

Tel Aviv University

OTHER

Sponsor Role: lead

Responsible Party

Michal Kahn

PhD student, Laboratory for Children's Sleep-Wake Disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avi Sadeh, Ds.c.

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv University

Geila Rozen, PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Ron Shaoul, M.D.

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Tel Aviv University

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

RMB-0425-13

Identifier Type: -

Identifier Source: org_study_id