Viewing Study NCT02700503


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Study NCT ID: NCT02700503
Status: COMPLETED
Last Update Posted: 2019-08-07
First Post: 2016-02-23
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Finding the Patient's Voice Diabetes Prevention Programs
Sponsor: Indiana University
Organization:

Study Overview

Official Title: Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
Status: COMPLETED
Status Verified Date: 2019-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: