Clinical trial NCT05356884: Adolescent-mediated Family Diabetes Intervention: American Samoa
Official title: An Adolescent-mediated Intervention to Improve Diabetes Prevention and Management in Pacific Islander Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
American Samoa
Adolescent
Pacific Islander
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-05-02
Enrollment: 340
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: Change in Adult Glycemic Control (HbA1c) 0-6 months
timeFrame: 0 - 6 months
measure: Change in Adult Glycemic Control (HbA1c) 0-12 months
timeFrame: 0 - 12 months
measure: Change in Adult Glycemic Control (HbA1c) 6-12 months
timeFrame: 6 - 12 months
measure: Change in Adult Body Mass Index (BMI) 0-6 months
timeFrame: 0 - 6 months
measure: Change in Adult Body Mass Index (BMI) 0-12 months
timeFrame: 0 - 12 months
measure: Change in Adult Body Mass Index (BMI) 6-12 months
timeFrame: 6 - 12 months
measure: Change in Adult Blood Pressure (BP) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adult Blood Pressure (BP) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adult Blood Pressure (BP) 6 - 12 months
timeFrame: 6 - 12 months
measure: Change in Adult Waist Circumference (WC) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adult Waist Circumference (WC) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adult Waist Circumference (WC) 6 - 12 months
timeFrame: 6 - 12 months
Secondary outcomes:
measure: Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months
timeFrame: 6 - 12 months
measure: Change in Adolescent Body Mass Index (BMI) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adolescent Body Mass Index (BMI) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adolescent Body Mass Index (BMI) 6 - 12 months
timeFrame: 6 - 12 months
measure: Change in Adolescent Blood Pressure (BP) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adolescent Blood Pressure (BP) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adolescent Blood Pressure (BP) 6 - 12 months
timeFrame: 6 - 12 months
measure: Change in Adolescent Waist Circumference (WC) 0 - 6 months
timeFrame: 0 - 6 months
measure: Change in Adolescent Waist Circumference (WC) 0 - 12 months
timeFrame: 0 - 12 months
measure: Change in Adolescent Waist Circumference (WC) 6 - 12 months
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Pago Pago
country: American Samoa
facility: OLaGA Research Center
Study officials:
affiliation: Yale University School of Public Health
name: Nicola L Hawley, PhD
role: PRINCIPAL_INVESTIGATOR
References: