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Completed

NCT Number: NCT03255902

Family Routines - Healthy Families

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenting classes

Behavioral

Parenting Classes:The Incredible Years curriculum

Primary outcomes

  1. 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

  1. Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • University of Michigan

Registry information

Official study title

Family Routine - Healthy Families

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Aug 21, 2017
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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