Together on Diabetes Study: Evaluation of a Pilot Diabetes Prevention and Management Program for American Indian Youth
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 19 |
| Updated: | 2/7/2015 |
| Start Date: | December 2011 |
| End Date: | December 2014 |
| Contact: | Allison Barlow, MPH, MA |
| Email: | abarlow@jhsph.edu |
| Phone: | 410-955-6931 |
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.
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.
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.
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.
Inclusion Criteria:
(YOUTH PARTICIPANT) --
- American Indian youth aged 10-19 years old at enrollment
- Resides within 1-hour transportation range (~ 50 miles) of the participating Indian
Health Service (IHS) medical facilities (Tuba City, Arizona; Chinle, Arizona;
Shiprock, New Mexico; Whiteriver, Arizona).
- Parent/guardian consent for youth under 18 years old.
- Referral from an Indian Health Services provider indicating a diagnosis by
laboratory test of type 2 diabetes or pre-diabetes OR considered at-risk for type 2
diabetes based on BMI ≥ 85th percentile and qualifying lab test
(SUPPORT PERSON) --
- Adults 18 years of age or older
- Identified on the Youth Participant consent form as the preferred Support Person to
be enrolled in the program
- Living with the enrolled Youth Participant or within 15 miles of the youth
Exclusion Criteria:
(YOUTH PARTICIPANT)
- Females who are pregnant or nursing or are planning to become pregnant within one
year of enrollment
- Diabetes due to secondary causes, such as exogenous steroids, Cushing's, or Cystic
Fibrosis
- Youth with type 1 diabetes.
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