Family Routines - Healthy Families

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Family Routine - Healthy Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255902
• Other study ID #: 2016-154
• Status: Completed
• Phase: N/A
• Start date: May 24, 2016
• Est. completion date: January 17, 2019

Study information

• Verified date: May 2019
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 17, 2019
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Parenting classes
Parenting Classes:The Incredible Years curriculum

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
William Beaumont Hospitals	University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Intervention on Evening Glucose Control.	Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.	After 6 weeks of classes
Secondary	Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value	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.	Pre intervention to 3 months post intervention