Status:
ACTIVE_NOT_RECRUITING
Adolescent-mediated Family Diabetes Intervention: American Samoa
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
14+ years
Phase:
NA
Brief Summary
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of an adolescent-mediated intervention designed to improve the glycemic control and self-care practices of ...
Detailed Description
The number of individuals diagnosed with Type 2 Diabetes in the United States (US) has more than doubled since 2000 to over 30 million, with an additional 84.1 million living with prediabetes. One min...
Eligibility Criteria
Inclusion
- Adolescent
- 14-17 years of age
- Samoan ethnicity
- Shares a household with a parent, legal guardian, or grandparent with type II diabetes
- Willing and able to consent to participation
- Able to participate in group sessions after school or on Saturday mornings
- Adult
- Samoan ethnicity
- Diagnosed with type II diabetes at least 12 months prior to study enrollment
- HbA1c \>= 6.5%
- Prescribed medication (tablets or insulin) to control their diabetes
- Willing and able to consent to participation
- Willing and able to consent to adolescent's participation
Exclusion
- Adolescent
- Planning to become pregnant during the study period (any adolescent who becomes pregnant will be excluded from analysis)
- Planning to leave American Samoa in the next 18 months
- Participants will be excluded if they report any of the following:
- Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg)
- Heart attack, stroke, or transient ischemic attack in the past year
- Treatment for cancer
- Chest pain or shortness of breath with minimal activity
- Chronic lung disease, or asthma requiring home oxygen therapy
- Contraindications to moderate physical activity
- Inability to read/speak Samoan and/or English.
- Overt diabetes (HbA1c ≥6.5%) based on point-of-care testing during the screening process
- Adult
- Planning to become pregnant during the study period (any adult who becomes pregnant will be excluded from analysis)
- Planning to leave American Samoa in the next 18 months
- Participants will be excluded if they report any of the following:
- Uncontrolled hypertension (systolic \>180 mmHg or diastolic \>105 mmHg)
- Heart attack, stroke, or transient ischemic attack in the past year
- Treatment for cancer
- Chest pain or shortness of breath with minimal activity
- Chronic lung disease, or asthma requiring home oxygen therapy
- Contraindications to moderate physical activity
- Inability to read/speak Samoan and/or English.
Key Trial Info
Start Date :
July 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05356884
Start Date
July 7 2022
End Date
December 31 2025
Last Update
July 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OLaGA Research Center
Pago Pago, American Samoa