Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT03397147
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-11
• Study Start: 2018-07-05
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-09
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• child between 5-9 years of age
• child have been diagnosed with type 1 diabetes for at least 12 months
• caregiver lives with child
• caregiver can read/speak English

Exclusion Criteria

• child has other major health problems or sleep disorders other than insufficient sleep or insomnia
• participating in other intervention studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Child Sleep Quality	3 months	Child sleep quality (measured with Child Sleep Habits Questionnaire)
Child Sleep Duration	3 months	Child sleep duration (measured with actigraphy)

Secondary Outcome Measures

Name	Time	Method
Parent Sleep Quality	3 months	and sleep quality (measured with Pittsburgh Sleep Quality Index)
Child Behavior Problems	3 months	Behavior problems measured with the Child Behavior Checklist (CBCL)
Parental Fear of Hypoglycemia	3 months	Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)
Glycemic Control	3 months	HbA1c, % glucose values in range
Parent Sleep Duration	3 months	Parent sleep duration (measured with actigraphy)
Parental Diabetes Distress	3 months	Diabetes distress (Problem Area In Diabetes - Parental Version Revised)
Parental Well-being	3 months	Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States