Adolescent-mediated Family Diabetes Intervention: American Samoa

NCT05356884 | Active Not Recruiting

• 2 other identifiers: 20000313251R01DK128277-01A1
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; American Samoa; Adolescent; Pacific Islander

Outcome Measures

Primary Outcomes (12)

• Change in Adult Glycemic Control (HbA1c) 0-6 months

  Glycated hemoglobin (marker of long term glycemic control)

  0 - 6 months

• Change in Adult Glycemic Control (HbA1c) 0-12 months

  Glycated hemoglobin (marker of long term glycemic control)

  0 - 12 months

• Change in Adult Glycemic Control (HbA1c) 6-12 months

  Glycated hemoglobin (marker of long term glycemic control)

  6 - 12 months

• Change in Adult Body Mass Index (BMI) 0-6 months

  Body mass index (measure of weight control)

  0 - 6 months

• Change in Adult Body Mass Index (BMI) 0-12 months

  Body mass index (measure of weight control)

  0 - 12 months

• Change in Adult Body Mass Index (BMI) 6-12 months

  Body mass index (measure of weight control)

  6 - 12 months

• Change in Adult Blood Pressure (BP) 0 - 6 months

  Blood Pressure (marker of hypertension risk)

  0 - 6 months

• Change in Adult Blood Pressure (BP) 0 - 12 months

  Blood Pressure (marker of hypertension risk)

  0 - 12 months

• Change in Adult Blood Pressure (BP) 6 - 12 months

  Blood Pressure (marker of hypertension risk)

  6 - 12 months

• Change in Adult Waist Circumference (WC) 0 - 6 months

  Waist circumference (measure of weight control)

  0 - 6 months

• Change in Adult Waist Circumference (WC) 0 - 12 months

  Waist circumference (measure of weight control)

  0 - 12 months

• Change in Adult Waist Circumference (WC) 6 - 12 months

  Waist circumference (measure of weight control)

  6 - 12 months

Secondary Outcomes (12)

• Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months

  0 - 6 months

• Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months

  0 - 12 months

• Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months

  6 - 12 months

• Change in Adolescent Body Mass Index (BMI) 0 - 6 months

  0 - 6 months

• Change in Adolescent Body Mass Index (BMI) 0 - 12 months

  0 - 12 months

Study Arms (2)

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.

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.

Behavioral: Leadership & Life Skills

Interventions

Diabetes Intervention BEHAVIORAL

A 12-session group-based intervention that will target diabetes knowledge and leadership and communication skills through facilitated discussion and experiential learning.

Diabetes Intervention

Leadership & Life Skills BEHAVIORAL

A 12-session group based intervention that will teach leadership and life skills (planning strategies, leadership values, emotional awareness, effective reasoning skills)

Leadership & Life Skills

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

OLaGA Research Center

Pago Pago, American Samoa

Location

Related Publications (1)

• 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.

  PMID: 36795707 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Leadership

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Personnel Management; Organization and Administration; Health Services Administration

Study Officials

• Nicola L Hawley, PhD

  Yale University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 2, 2022
• Study Start: July 7, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol has been published and is available at: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0279084 Detailed intervention and control curricula will be available in August 2024 upon completion of data collection.
• Access Criteria: All materials will be made publicly available.

Locations

AM (1)