Finding the Patient's Voice Diabetes Prevention Programs

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700503
• Other study ID #: 1510313617
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Riley Children's Specialties	Carmel	Indiana
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Riley Children's Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart		12 months
Secondary	Hemoglobin A1C		12 months
Secondary	Physical activity	self-report	12 months
Secondary	Quality of life	Pediatric Quality of Life Inventory	12 months
Secondary	Intervention group session attendance		12 months
Secondary	Dietary records	Semi-quantitative food frequency questionniare	12 months