Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The objective of the Together on Diabetes study is to test the efficacy of a pilot
      intervention to improve the prevention and management of type 2 diabetes among American
      Indian youth.

      The primary aim of this study is to determine the impact of the Together on Diabetes pilot
      intervention on youth diabetes risk behaviors, including:

        -  Improvement in youth dietary intake, with a specific focus on reducing the percent of
           total calories from fat.

        -  Improvement in youth physical activity, with a specific focus on increasing the number
           of minutes of physical activity each week.

      An additional primary aim of the study is to determine the feasibility and acceptability of
      the pilot intervention and evaluation, including program adherence and program satisfaction.

      The secondary aim of this study is to determine the feasibility of collecting data to
      determine program impact on a number of physiological measures.
    

Detailed description: 
      This is a single group pre-post study designed to evaluate the feasibility and effectiveness
      of a pilot intervention at improving the prevention and management of type 2 diabetes among
      American Indian youth. The intervention uses a Family Health Coach model to work with
      families of youth with diabetes or at high risk of diabetes. Health Coaches visit families in
      their homes and conduct intervention sessions with both youth and a designated adult 'support
      person' (e.g., parent, guardian, etc). For Youth Participants, the pilot intervention
      consists of 12 sessions (45-60 minutes in duration) delivered during a 6-month intervention
      phase, plus 6 check-ins delivered during a 6-month follow-up phase. There are also 4 optional
      social support visits for the Youth Participants in order to provide necessary assistance
      with challenges the youth may be facing. For Support Persons, the pilot intervention consists
      of 4 family skill building sessions (20-30 minutes in length) delivered during the first 4
      months of the Youth Participant's intervention phase. Support Persons will also be welcomed
      and encouraged to attend any of the Youth Participant sessions. All sessions are designed to
      be taught at the participant's home, but they may also occur at another location chosen by
      the participant (e.g. school, study office, clinic). Outcome data will be collected at
      Baseline, 3 months following Baseline, 6 months following Baseline, and 12 months following
      Baseline.
    

Intervention name(s): Together on Diabetes-Hopkins
Intervention type(s): Behavioral
Intervention description(s): The Johns Hopkins Center for American Indian Health, with support from Bristol-Myers Squibb Foundation, Inc. is adapting a Family Health Coach model for diabetes prevention with four southwestern tribal communities. Specifically, Johns Hopkins Center for American Indian Health has designed a paraprofessional delivered pilot intervention aimed at improving the prevention and management of type 2 diabetes among American Indian youth. For Youth Participants, the pilot intervention consists of 12 sessions delivered during a 6-month intervention phase, plus 6 check-ins delivered during a 6-month follow-up phase. For Support Persons, the pilot intervention consists of 4 family skill building sessions delivered during the first 4 months of the Youth Participant's intervention phase.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: American Indian; Diabetes; Pre-diabetes; Family health Coach