Clinical trial NCT02721602: Families Preventing Diabetes Together
Official title: Families Preventing Diabetes Together
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Pediatric Obesity
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study proposes to study the feasibility and acceptability of the Families Preventing Diabetes Together Intervention among 40 families who have one parent diagnosed with type 2 diabetes and at least 1 child between the ages of 5-14 years of age. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Detailed description: The current study is a randomized controlled trial with 40 families. Twenty families will be randomly assigned to receive usual care consisting of diabetes education delivered through Fairview Health Services. An additional 20 families will be randomized to a family-based, in-person program that focuses on nutrition education, the development of meal planning and cooking skills and promotion of healthful eating for families; the program will augment usual care and diabetes education received from Fairview Health Services for the parent with diabetes. Parents with diabetes who are randomized to the intervention group will also participate in one goal-setting phone call with intervention staff at one point during the intervention program.

Adult patients and their families will be recruited in two ways:

1. from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and
2. through MyChart messages informing them about the study.

Adults between the ages of 25 and 55 years who have a diagnosis of Type 2 diabetes, who have participated in at least some diabetes education through Fairview Health Services, and who have at least one child between the ages of 7-12 years of age will be invited to participate in the study. Successful recruitment, measurement and randomization of patients and their families will provide data for our aim of assessing feasibility. Patient and family participation in the intervention and feedback via the post-intervention surveys will provide data for our aim of acceptability.

Eligibility criteria: Inclusion Criteria:

* Parent with Type 2 diabetes
* At least 1 child between the ages of 7-12
* Parent has completed at least some Diabetes Education through Fairview Health System

Exclusion Criteria:

* Parent with Type 2 diabetes does not speak or read in English
* No parents with Type 2 diabetes or no children ages 7-12 years
* Parent with Type 2 diabetes has not completed at least some Diabetes Education

Primary outcomes:
measure: Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
timeFrame: up to 6 months
measure: Feasibility of the study measured via the ability to successfully measure 100% of the adults and 80% of the children in enrolled families at baseline measurements.
timeFrame: up to 6 months
measure: Feasibility of the study measured via the ability to successfully retain 85% of the enrolled families over the course of the study measured by their participate in post-intervention measurements.
timeFrame: up to 6 months
measure: Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
timeFrame: up to 6 months
measure: Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
timeFrame: up to 6 months
Secondary outcomes:
measure: Child BMIz
timeFrame: up to 6 months
measure: Blood glucose control in parent with Type 2 diabetes
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, School of Nursing
state: Minnesota
Study officials:
References: