Family Routines - Healthy Families
Primary Purpose
Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parenting classes
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Families attending parenting classes
Arm Description
Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03255902
First Posted
August 16, 2017
Last Updated
May 29, 2019
Sponsor
William Beaumont Hospitals
Collaborators
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03255902
Brief Title
Family Routines - Healthy Families
Official Title
Family Routine - Healthy Families
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
January 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
William Beaumont Hospitals
Collaborators
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Families attending parenting classes
Arm Type
Experimental
Arm Description
Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Parenting classes
Intervention Description
Parenting Classes:The Incredible Years curriculum
Primary Outcome Measure Information:
Title
Effect of Intervention on Evening Glucose Control.
Description
Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.
Time Frame
After 6 weeks of classes
Secondary Outcome Measure Information:
Title
Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value
Description
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.
Time Frame
Pre intervention to 3 months post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Marvicsin, PhD
Organizational Affiliation
William Beaumont Children's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Family Routines - Healthy Families
We'll reach out to this number within 24 hrs