Family Routines - Healthy Families

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT03255902
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.

Detailed Description

The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.

Study Timeline

• Study Start: 2016-05-24
• Primary Completion: 2017-03-01
• Study First Submitted: 2017-08-16
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-21
• Results First Submitted: 2018-07-09
• Study Completion: 2019-01-17
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-29
• Results First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Self identification as primary care giver of child that fits following criteria:

   1. Age 2 - 5 years
   2. Diagnosis of Type 1 diabetes
   3. Most recent Hemoglobin A1c (HbA1c) > 8.0
   4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital

2. English fluency

Exclusion Criteria

1. Cognitively impaired
2. Does not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effect of Intervention on Evening Glucose Control.	After 6 weeks of classes	Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value	Pre intervention to 3 months post intervention	3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.