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Families Preventing Diabetes Together

Primary Purpose

Type 2 Diabetes, Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families Preventing Diabetes Together
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 2 Diabetes

Eligibility Criteria

2 Years - 55 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • University of Minnesota, School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Measurement Only

Arm 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.

No intervention only measurements

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 16, 2016
Last Updated
August 23, 2017
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02721602
Brief Title
Families Preventing Diabetes Together
Official Title
Families Preventing Diabetes Together
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: from Fairview Health Service's clinics in the North metropolitan area with the assistance of Fairview Health Service diabetes educators, and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Pediatric Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Measurement Only
Arm Type
No Intervention
Arm Description
No intervention only measurements
Intervention Type
Behavioral
Intervention Name(s)
Families Preventing Diabetes Together
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of the study measured via the ability to successfully recruit 30-40 families for the study.
Description
Ability to successfully recruit 30- 40 families in the study will determine feasibility.
Time Frame
up to 6 months
Title
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.
Description
Ability to successfully measure 100% of recruited adults and 80% of children in enrolled families at baseline measurements will determine feasibility.
Time Frame
up to 6 months
Title
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.
Description
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.
Time Frame
up to 6 months
Title
Acceptability of the intervention measured via family participation rates (families attend at least 70% of the sessions).
Description
Family participation in the intervention (attending at least 70% of sessions) will determine acceptability.
Time Frame
up to 6 months
Title
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Description
Acceptability of the intervention measured via family feedback indicating at least 90% approve of the sessions on post-intervention surveys.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Child BMIz
Description
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.
Time Frame
up to 6 months
Title
Blood glucose control in parent with Type 2 diabetes
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Minnesota, School of Nursing
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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