Clinical trial NCT02700503: Finding the Patient's Voice Diabetes Prevention Programs
Official title: Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Prediabetic State
Keywords: Diabetes prevention
type 2 diabetes
prediabetes
family
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
First posted: 2016-03-07
Enrollment: 146
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
timeFrame: 12 months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 12 months
measure: Physical activity
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Intervention group session attendance
timeFrame: 12 months
measure: Dietary records
timeFrame: 12 months
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Riley Children's Specialties
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Tamara Hannon, MD
role: PRINCIPAL_INVESTIGATOR
References: