Families Preventing Diabetes Together

University of Minnesota (UMN)

Status: Completed

Conditions: Pediatric Obesity; Type 2 Diabetes

Treatments: Behavioral: Families Preventing Diabetes Together

Study type: Interventional

Funder types: Other

Identifiers

NCT02721602

23085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 2 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

7 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Families in the Families Preventing Diabetes Together 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.

Treatment:

Behavioral: Families Preventing Diabetes Together

Measurement Only

No Intervention group

Description:

No intervention only measurements