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Clinical Trials/NCT03255902
NCT03255902
Completed
N/A

Family Routine - Healthy Families

William Beaumont Hospitals0 sites7 target enrollmentMay 24, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
William Beaumont Hospitals
Enrollment
7
Primary Endpoint
Effect of Intervention on Evening Glucose Control.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2016
End Date
January 17, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Donna Marvicsin

Nurse Practitioner, Pediatric Endocrinology

William Beaumont Hospitals

Eligibility Criteria

Inclusion Criteria

  • Self identification as primary care giver of child that fits following criteria:
  • Age 2 - 5 years
  • Diagnosis of Type 1 diabetes
  • Most recent Hemoglobin A1c (HbA1c) \> 8.0
  • Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
  • English fluency

Exclusion Criteria

  • Cognitively impaired
  • Does not meet inclusion criteria

Outcomes

Primary Outcomes

Effect of Intervention on Evening Glucose Control.

Time Frame: 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 Outcomes

  • Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value(Pre intervention to 3 months post intervention)

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