Diabetes Mellitus, Type 1NCT03255902
Family Routines - Healthy Families
A study testing Parenting classes in people with Diabetes Mellitus, Type 1, run by Corewell Health East.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Parenting classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 24 May 2016to 17 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Cognitively impaired
- Does not meet inclusion criteria
About this study
Official title: Family Routine - 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Parenting classes
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenting classesBehavioural
Parenting Classes:The Incredible Years curriculum
| Study group | Role | What they receive |
|---|---|---|
| Families attending parenting classes | Experimental | Families attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires Receives: Behavioral: Parenting classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 6 weeks of classes
Secondary outcomes (1)
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.
Measured: Pre intervention to 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start24 May 2016
- Primary completion1 Mar 2017
- Study completion17 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Donna Marvicsin, Corewell Health East
- Investigators
- Donna Marvicsin, PhD, Principal investigator, William Beaumont Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255902
- Sponsor's protocol ID
- 2016-154
- Status last verified
- May 2019
- First submitted
- 16 Aug 2017
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Routine - Healthy Families
- ClinicalTrials.gov ID
- NCT03255902
- Acronym / sponsor ID
- 2016-154
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 24 May 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 17 Jan 2019 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Families attending parenting classes | Experimental | Behavioral: Parenting classesFamilies attended 6 parenting sessions, filled out daily glucose screens, \& questionnaires |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Self identification as primary care giver of child that fits following criteria:
- English fluency
Key exclusion criteria (2 listed)
- Cognitively impaired
- Does not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenting classesParenting Classes:The Incredible Years curriculum | Behavioural | Families attending parenting classes |
Primary outcome
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.
1 secondary outcome
Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value
Time frame: Pre intervention to 3 months post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Marvicsin, PhD principal investigator
William Beaumont Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Parenting classes in people with Diabetes Mellitus, Type 1, run by Corewell Health East.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Intervention on Evening Glucose Control. (time frame: After 6 weeks of classes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.