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Finding the Patient's Voice Diabetes Prevention Programs

Primary Purpose

Diabetes Mellitus, Type 2, Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Encourage 2.0
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes prevention, type 2 diabetes, prediabetes, family

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
  2. At least two of the following risk factors:

    • Have been diagnosed with prediabetes;
    • Have a family history of T2DM in first- and second-degree relatives;
    • Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
    • Have conditions associated with insulin resistance; and/or
    • Have had gestational diabetes or were exposed to gestational diabetes in utero.
  3. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).

Exclusion Criteria:

1. Type 2 diagnosis

Sites / Locations

  • Riley Children's Specialties
  • Indiana University School of Medicine
  • Riley Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.

Outcomes

Primary Outcome Measures

Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart

Secondary Outcome Measures

Hemoglobin A1C
Physical activity
self-report
Quality of life
Pediatric Quality of Life Inventory
Intervention group session attendance
Dietary records
Semi-quantitative food frequency questionniare

Full Information

First Posted
February 23, 2016
Last Updated
August 5, 2019
Sponsor
Indiana University
Collaborators
Indiana University Health
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1. Study Identification

Unique Protocol Identification Number
NCT02700503
Brief Title
Finding the Patient's Voice Diabetes Prevention Programs
Official Title
Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana University Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.
Detailed Description
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including: helping youth/families understand the importance of prevention, on-going interest and participation, and differing personal beliefs. Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Prediabetic State
Keywords
Diabetes prevention, type 2 diabetes, prediabetes, family

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
Intervention Type
Behavioral
Intervention Name(s)
Encourage 2.0
Intervention Description
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
Primary Outcome Measure Information:
Title
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hemoglobin A1C
Time Frame
12 months
Title
Physical activity
Description
self-report
Time Frame
12 months
Title
Quality of life
Description
Pediatric Quality of Life Inventory
Time Frame
12 months
Title
Intervention group session attendance
Time Frame
12 months
Title
Dietary records
Description
Semi-quantitative food frequency questionniare
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height) At least two of the following risk factors: Have been diagnosed with prediabetes; Have a family history of T2DM in first- and second-degree relatives; Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders); Have conditions associated with insulin resistance; and/or Have had gestational diabetes or were exposed to gestational diabetes in utero. A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D). Exclusion Criteria: 1. Type 2 diagnosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Hannon, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riley Children's Specialties
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Riley Children's Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
undecided

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Finding the Patient's Voice Diabetes Prevention Programs

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