Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes
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.
Interventions
BEHAVIORALParenting classes
Parenting Classes:The Incredible Years curriculum
Sponsors
University of Michigan
Corewell Health East
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Families Attending Parenting Classes Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
Parenting classes: Parenting Classes:The Incredible Years curriculum | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Families Attending Parenting Classes |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 7 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
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.
Time frame: After 6 weeks of classes
Population: 2 participants did not complete study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Families Attending Parenting Classes | Effect of Intervention on Evening Glucose Control. | 2 Participants |
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.
Time frame: Pre intervention to 3 months post intervention
Population: 2 participants did not complete study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Families Attending Parenting Classes | Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value | -0.3 percent of HbA1c |