Families Preventing Diabetes Together

Type 2 Diabetes Clinical Trial

Official title:

Families Preventing Diabetes Together

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721602
• Other study ID #: 23085
• Status: Completed
• Phase: N/A
• First received: February 16, 2016
• Last updated: August 23, 2017
• Start date: February 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pediatric Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Families Preventing Diabetes Together
Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.

Locations

Country	Name	City	State
United States	University of Minnesota, School of Nursing	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.	Ability to successfully recruit 30- 40 families in the study will determine feasibility.	up to 6 months
Primary	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.	Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.	up to 6 months
Primary	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.	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.	up to 6 months
Primary	Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).	Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.	up to 6 months
Primary	Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.	Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.	up to 6 months
Secondary	Child BMIz	Objectively measured height and weight will be used to determine child BMIz values to see if the study resulted in any changes in BMIz between baseline measurements and post-intervention measurements.	up to 6 months
Secondary	Blood glucose control in parent with Type 2 diabetes	Change in type 2 diabetic parent's A1C values over the course of the study will be used to measure parent blood glucose control between baseline measurements and post-intervention measurements.	up to 6 months