Families Preventing Diabetes Together

NCT02721602 | Completed

• 1 other identifier: 23085
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Pediatric Obesity

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Child BMIz

  up to 6 months

• Blood glucose control in parent with Type 2 diabetes

  up to 6 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Families Preventing Diabetes Together

Measurement Only

NO INTERVENTION

No intervention only measurements

Interventions

Families Preventing Diabetes Together BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 2 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota, School of Nursing

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pediatric Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: March 29, 2016
• Study Start: February 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)