Skip to main content
OpenTrials
Completed

NCT Number: NCT02700503

Finding the Patient's Voice Diabetes Prevention Programs

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Children's Specialties, Carmel, Indiana, United States

Loading trial locations.

About this study

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:

  • helping youth/families understand the importance of prevention,
  • on-going interest and participation, and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
  • 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.
  • 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

  • Type 2 diagnosis

Treatment and study plan

Encourage 2.0

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.

Primary outcomes

  1. Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart

    Time frame: 12 months

Secondary outcomes

  1. Hemoglobin A1C

    Time frame: 12 months

  2. Physical activity

    Time frame: 12 months

    self-report

  3. Quality of life

    Time frame: 12 months

    Pediatric Quality of Life Inventory

  4. Intervention group session attendance

    Time frame: 12 months

  5. Dietary records

    Time frame: 12 months

    Semi-quantitative food frequency questionniare

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana University Health

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.