Finding the Patient's Voice Diabetes Prevention Programs

Indiana University

Status: Completed

Conditions: Prediabetic State; Diabetes Mellitus, Type 2

Treatments: Behavioral: Encourage 2.0

Study type: Interventional

Funder types: Other

Identifiers

NCT02700503

1510313617

Details and patient eligibility

About

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

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 1 patient group

Intervention

Experimental group

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.

Treatment:

Behavioral: Encourage 2.0