Finding the Patient's Voice Diabetes Prevention Programs

NCT ID: NCT02700503

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-06-30

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.

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Encourage 2.0

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University Health

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Tamara S. Hannon

Associate Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamara Hannon, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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

Countries

United States

Other Identifiers

1510313617

Identifier Type: -

Identifier Source: org_study_id