Diabetes Mellitus, Type 2NCT05356884
Adolescent-mediated Family Diabetes Intervention: American Samoa
A study testing Diabetes Intervention and Leadership & Life Skills in people with Diabetes Mellitus, Type 2, run by Yale University at 1 site in American Samoa.
Trial 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 a parent/grandparent. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes Intervention and Leadership & Life Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteAmerican Samoa
- Study dates
- 7 Jul 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
American Samoa1 site
OLaGA Research Center
Pago Pago
About this study
Official title: An Adolescent-mediated Intervention to Improve Diabetes Prevention and Management in Pacific Islander Families
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.
Read the 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 minority group at particular risk is Pacific Islanders (PIs), who are at disproportionate risk and face many barriers (structural and cultural) to engaging in prevention or self-care. To address the critical need for diabetes prevention and treatment programs that target PIs, and building on the family-centered culture, the objective of this project is to pilot test and evaluate a randomized controlled trial of an adolescent-mediated intervention designed to improve the glycemic control and self-care practices of a paired, adult family member with diagnosed diabetes. Dyads (n=160 dyads; an adolescent without diabetes and a parent/grandparent diagnosed with diabetes who share a household) will be randomized. Adolescents will receive either a six-month diabetes intervention or a leadership and life skills-focused control curriculum in groups (n=10 participants in each group). Aside from planned research assessments there will be no contact with the adults in the dyad, who will proceed with their usual diabetes care. To test the hypothesis that adolescents receiving the intervention will be effective conduits of diabetes knowledge and will support their paired adult in the adoption of self-care strategies, the primary efficacy outcomes will be adult glycemic control and cardiovascular risk factors (BMI, blood pressure, waist circumference). Secondarily, since exposure to the intervention may encourage positive behavior change in the adolescent themselves similar outcomes will be measured in the adolescents. Outcomes will be measured at baseline, at the end of the active intervention phase (six months post-randomization) and at 12-months post-randomization, to examine maintenance of intervention effects in the absence of contact. To determine potential for long-term sustainability and scale up, program acceptability, feasibility, fidelity, reach, and cost will be examined. Successful completion of the study aims and proof of efficacy would produce an innovative, scalable program with high potential for replication in other similar, low-resource, family-centered, ethnic minority groups across the US who are the ideal beneficiaries of innovations to reduce chronic disease risk and eliminate health disparities.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes Intervention, Leadership & Life Skills
- Keywords
- Diabetes Mellitus, American Samoa, Adolescent, Pacific Islander
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes InterventionBehavioural
A 12-session group-based intervention that will target diabetes knowledge and leadership and communication skills through facilitated discussion and experiential learning.
Leadership & Life SkillsBehavioural
A 12-session group based intervention that will teach leadership and life skills (planning strategies, leadership values, emotional awareness, effective reasoning skills)
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Intervention | Experimental | 12-session behavioral intervention covering diabetes pathology, self-monitoring, medication adherence, identifying and responding to emergency situations, diet, physical activity, health care utilization and maintaining healthy habits. Receives: Behavioral: Diabetes Intervention |
| Leadership & Life Skills | Active comparator | 12-session leadership and life skills intervention focusing on adolescent self-esteem, self-efficacy, communication skills, mindfulnesss, healthy habits. Receives: Behavioral: Leadership & Life Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Glycemic Control (HbA1c) 0-6 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 0 - 6 months
Change in Adult Glycemic Control (HbA1c) 0-12 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 0 - 12 months
Change in Adult Glycemic Control (HbA1c) 6-12 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 6 - 12 months
Change in Adult Body Mass Index (BMI) 0-6 months
Body mass index (measure of weight control)
Measured: 0 - 6 months
Change in Adult Body Mass Index (BMI) 0-12 months
Body mass index (measure of weight control)
Measured: 0 - 12 months
Change in Adult Body Mass Index (BMI) 6-12 months
Body mass index (measure of weight control)
Measured: 6 - 12 months
Change in Adult Blood Pressure (BP) 0 - 6 months
Blood Pressure (marker of hypertension risk)
Measured: 0 - 6 months
Change in Adult Blood Pressure (BP) 0 - 12 months
Blood Pressure (marker of hypertension risk)
Measured: 0 - 12 months
Change in Adult Blood Pressure (BP) 6 - 12 months
Blood Pressure (marker of hypertension risk)
Measured: 6 - 12 months
Change in Adult Waist Circumference (WC) 0 - 6 months
Waist circumference (measure of weight control)
Measured: 0 - 6 months
Change in Adult Waist Circumference (WC) 0 - 12 months
Waist circumference (measure of weight control)
Measured: 0 - 12 months
Change in Adult Waist Circumference (WC) 6 - 12 months
Waist circumference (measure of weight control)
Measured: 6 - 12 months
Secondary outcomes (12)
Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 0 - 6 months
Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 0 - 12 months
Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Measured: 6 - 12 months
Change in Adolescent Body Mass Index (BMI) 0 - 6 months
Body mass index (measure of weight control)
Measured: 0 - 6 months
Change in Adolescent Body Mass Index (BMI) 0 - 12 months
Body mass index (measure of weight control)
Measured: 0 - 12 months
Change in Adolescent Body Mass Index (BMI) 6 - 12 months
Body mass index (measure of weight control)
Measured: 6 - 12 months
Change in Adolescent Blood Pressure (BP) 0 - 6 months
Blood Pressure (marker of hypertension risk)
Measured: 0 - 6 months
Change in Adolescent Blood Pressure (BP) 0 - 12 months
Blood Pressure (marker of hypertension risk)
Measured: 0 - 12 months
Change in Adolescent Blood Pressure (BP) 6 - 12 months
Blood Pressure (marker of hypertension risk)
Measured: 6 - 12 months
Change in Adolescent Waist Circumference (WC) 0 - 6 months
Waist circumference (measure of weight control)
Measured: 0 - 6 months
Change in Adolescent Waist Circumference (WC) 0 - 12 months
Waist circumference (measure of weight control)
Measured: 0 - 12 months
Change in Adolescent Waist Circumference (WC) 6 - 12 months
Waist circumference (measure of weight control)
Measured: 6 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start7 Jul 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola L Hawley, PhD, Principal investigator, Yale University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356884
- Sponsor's protocol ID
- 2000031325
- Other IDs
- 1R01DK128277-01A1
- Status last verified
- Oct 2026
- First submitted
- 26 Apr 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other researchers for the purpose of analyses agreed upon with the Principal Investigator
Publications
Hawley NL, Rivara AC, Naseri J, Faumuina K, Potoa'e-Solaita N, Iopu F, Faiai M, Naveno E, Tasele S, Lefale T, Lantini R, Carlson JC, Rabin TL, Semaia P, Mugadza P, Rosen RK. Protocol: Implementation and evaluation of an adolescent-mediated intervention to improve glycemic control and diabetes self-management among Samoan adults. PLoS One. 2023 Feb 16;18(2):e0279084. doi: 10.1371/journal.pone.0279084. eCollection 2023.
PubMed 36795707
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adolescent-mediated Intervention to Improve Diabetes Prevention and Management in Pacific Islander Families
- ClinicalTrials.gov ID
- NCT05356884
- Acronym / sponsor ID
- 2000031325
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, American Samoa, Adolescent, Pacific Islander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 minority group at particular risk is Pacific Islanders (PIs), who are at disproportionate risk and face many barriers (structural and cultural) to engaging in prevention or self-care. To address the critical need for diabetes prevention and treatment programs that target PIs, and building on the family-centered culture, the objective of this project is to pilot test and evaluate a randomized controlled trial of an adolescent-mediated intervention designed to improve the glycemic control and self-care practices of a paired, adult family member with diagnosed diabetes. Dyads (n=160 dyads; an adolescent without diabetes and a parent/grandparent diagnosed with diabetes who share a household) will be randomized. Adolescents will receive either a six-month diabetes intervention or a leadership and life skills-focused control curriculum in groups (n=10 participants in each group). Aside from planned research assessments there will be no contact with the adults in the dyad, who will proceed with their usual diabetes care. To test the hypothesis that adolescents receiving the intervention will be effective conduits of diabetes knowledge and will support their paired adult in the adoption of self-care strategies, the primary efficacy outcomes will be adult glycemic control and cardiovascular risk factors (BMI, blood pressure, waist circumference). Secondarily, since exposure to the intervention may encourage positive behavior change in the adolescent themselves similar outcomes will be measured in the adolescents. Outcomes will be measured at baseline, at the end of the active intervention phase (six months post-randomization) and at 12-months post-randomization, to examine maintenance of intervention effects in the absence of contact. To determine potential for long-term sustainability and scale up, program acceptability, feasibility, fidelity, reach, and cost will be examined. Successful completion of the study aims and proof of efficacy would produce an innovative, scalable program with high potential for replication in other similar, low-resource, family-centered, ethnic minority groups across the US who are the ideal beneficiaries of innovations to reduce chronic disease risk and eliminate health disparities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes Intervention | Experimental | Behavioral: Diabetes Intervention12-session behavioral intervention covering diabetes pathology, self-monitoring, medication adherence, identifying and responding to emergency situations, diet, physical activity, health care utilization and maintaining healthy habits. |
| Leadership & Life Skills | Active comparator | Behavioral: Leadership & Life Skills12-session leadership and life skills intervention focusing on adolescent self-esteem, self-efficacy, communication skills, mindfulnesss, healthy habits. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- Overt diabetes (HbA1c ≥6.5%) based on point-of-care testing during the screening process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes InterventionA 12-session group-based intervention that will target diabetes knowledge and leadership and communication skills through facilitated discussion and experiential learning. | Behavioural | Diabetes Intervention |
| Leadership & Life SkillsA 12-session group based intervention that will teach leadership and life skills (planning strategies, leadership values, emotional awareness, effective reasoning skills) | Behavioural | Leadership & Life Skills |
Primary outcome
Change in Adult Glycemic Control (HbA1c) 0-6 months
Time frame: 0 - 6 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Glycemic Control (HbA1c) 0-12 months
Time frame: 0 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Glycemic Control (HbA1c) 6-12 months
Time frame: 6 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Body Mass Index (BMI) 0-6 months
Time frame: 0 - 6 months
Body mass index (measure of weight control)
Change in Adult Body Mass Index (BMI) 0-12 months
Time frame: 0 - 12 months
Body mass index (measure of weight control)
Change in Adult Body Mass Index (BMI) 6-12 months
Time frame: 6 - 12 months
Body mass index (measure of weight control)
Change in Adult Blood Pressure (BP) 0 - 6 months
Time frame: 0 - 6 months
Blood Pressure (marker of hypertension risk)
Change in Adult Blood Pressure (BP) 0 - 12 months
Time frame: 0 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adult Blood Pressure (BP) 6 - 12 months
Time frame: 6 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adult Waist Circumference (WC) 0 - 6 months
Time frame: 0 - 6 months
Waist circumference (measure of weight control)
Change in Adult Waist Circumference (WC) 0 - 12 months
Time frame: 0 - 12 months
Waist circumference (measure of weight control)
Change in Adult Waist Circumference (WC) 6 - 12 months
Time frame: 6 - 12 months
Waist circumference (measure of weight control)
12 secondary outcomes
Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months
Time frame: 0 - 6 months
Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months
Time frame: 0 - 12 months
Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months
Time frame: 6 - 12 months
Change in Adolescent Body Mass Index (BMI) 0 - 6 months
Time frame: 0 - 6 months
Change in Adolescent Body Mass Index (BMI) 0 - 12 months
Time frame: 0 - 12 months
Change in Adolescent Body Mass Index (BMI) 6 - 12 months
Time frame: 6 - 12 months
Change in Adolescent Blood Pressure (BP) 0 - 6 months
Time frame: 0 - 6 months
Change in Adolescent Blood Pressure (BP) 0 - 12 months
Time frame: 0 - 12 months
Change in Adolescent Blood Pressure (BP) 6 - 12 months
Time frame: 6 - 12 months
Change in Adolescent Waist Circumference (WC) 0 - 6 months
Time frame: 0 - 6 months
Change in Adolescent Waist Circumference (WC) 0 - 12 months
Time frame: 0 - 12 months
Change in Adolescent Waist Circumference (WC) 6 - 12 months
Time frame: 6 - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Derived from this study: PubMed 36795707Hawley NL, Rivara AC, Naseri J, Faumuina K, Potoa'e-Solaita N, Iopu F, Faiai M, Naveno E, Tasele S, Lefale T, Lantini R, Carlson JC, Rabin TL, Semaia P, Mugadza P, Rosen RK. Protocol: Implementation and evaluation of an adolescent-mediated intervention to improve glycemic control and diabetes self-management among Samoan adults. PLoS One. 2023 Feb 16;18(2):e0279084. doi: 10.1371/journal.pone.0279084. eCollection 2023.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other researchers for the purpose of analyses agreed upon with the Principal Investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola L Hawley, PhD principal investigator
Yale University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Intervention and Leadership & Life Skills in people with Diabetes Mellitus, Type 2, run by Yale University at 1 site in American Samoa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in American Samoa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adult Glycemic Control (HbA1c) 0-6 months (time frame: 0 - 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356884, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.