Finding the Patient's Voice Diabetes Prevention Programs

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Prediabetic State
• Interventions: Behavioral: Encourage 2.0

• Registration Number: NCT02700503
• Lead Sponsor: Indiana University

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:

1. helping youth/families understand the importance of prevention,

2. on-going interest and participation, and

3. 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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).

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Exclusion Criteria

1. Type 2 diagnosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Encourage 2.0	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 Measures

Name	Time	Method
Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart	12 months

Secondary Outcome Measures

Name	Time	Method
Intervention group session attendance	12 months
Dietary records	12 months	Semi-quantitative food frequency questionniare
Physical activity	12 months	self-report
Quality of life	12 months	Pediatric Quality of Life Inventory
Hemoglobin A1C	12 months

Trial Locations

Locations (3)

Riley Children's Specialties; 🇺🇸 Carmel, Indiana, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States