Finding the Patient's Voice Diabetes Prevention Programs

Study Overview
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Brief Summary
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This study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

Detailed Description
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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.

Official Title
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Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs

Conditions
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Diabetes Mellitus, Type 2, Prediabetic State

Intervention / Treatment
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* Behavioral: Encourage 2.0


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Encourage 2.0<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C |  | 12 months | 
| Physical activity | self-report | 12 months | 
| Quality of life | Pediatric Quality of Life Inventory | 12 months | 
| Intervention group session attendance |  | 12 months | 
| Dietary records | Semi-quantitative food frequency questionniare | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes prevention, type 2 diabetes, prediabetes, family