NCT05356884Completed
Adolescent-mediated Family Diabetes Intervention: American Samoa
An Adolescent-mediated Intervention to Improve Diabetes Prevention and Management in Pacific Islander Families
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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 a parent/grandparent. The preliminary impact of the intervention on adult glycemic control (HbA1c) and self-care behaviors, as well as adolescent risk factors, will be explored with the goal of informing future programs that can be scaled to reduce diabetes burden and eliminate health disparities among at risk, ethnic minority groups.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 360 (actual)
- First submitted
- 26 Apr 2022
- Start date
- 7 Jul 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Yale University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05356884
What you commit to
- Study type: Interventional
- Participants enrolled: 360
- From 7 Jul 2022 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Lab values
- Overt diabetes (HbA1c ≥6.5%) based on point-of-care testing during the screening process
- Adult
Other
- 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
- 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
Who the study is looking for
- 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
Age in the registry: 14 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLaGA Research Center Coordinator of this site? Confirm its status | Pago Pago | American Samoa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.