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Adolescent-mediated Family Diabetes Intervention: American Samoa

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
American Samoa
Study Type
Interventional
Intervention
Diabetes Intervention
Leadership & Life Skills
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, American Samoa, Adolescent, Pacific Islander

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • OLaGA Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diabetes Intervention

Leadership & Life Skills

Arm Description

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.

12-session leadership and life skills intervention focusing on adolescent self-esteem, self-efficacy, communication skills, mindfulnesss, healthy habits.

Outcomes

Primary Outcome Measures

Change in Adult Glycemic Control (HbA1c) 0-6 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Glycemic Control (HbA1c) 0-12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Glycemic Control (HbA1c) 6-12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adult Body Mass Index (BMI) 0-6 months
Body mass index (measure of weight control)
Change in Adult Body Mass Index (BMI) 0-12 months
Body mass index (measure of weight control)
Change in Adult Body Mass Index (BMI) 6-12 months
Body mass index (measure of weight control)
Change in Adult Blood Pressure (BP) 0 - 6 months
Blood Pressure (marker of hypertension risk)
Change in Adult Blood Pressure (BP) 0 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adult Blood Pressure (BP) 6 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adult Waist Circumference (WC) 0 - 6 months
Waist circumference (measure of weight control)
Change in Adult Waist Circumference (WC) 0 - 12 months
Waist circumference (measure of weight control)
Change in Adult Waist Circumference (WC) 6 - 12 months
Waist circumference (measure of weight control)

Secondary Outcome Measures

Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months
Glycated hemoglobin (marker of long term glycemic control)
Change in Adolescent Body Mass Index (BMI) 0 - 6 months
Body mass index (measure of weight control)
Change in Adolescent Body Mass Index (BMI) 0 - 12 months
Body mass index (measure of weight control)
Change in Adolescent Body Mass Index (BMI) 6 - 12 months
Body mass index (measure of weight control)
Change in Adolescent Blood Pressure (BP) 0 - 6 months
Blood Pressure (marker of hypertension risk)
Change in Adolescent Blood Pressure (BP) 0 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adolescent Blood Pressure (BP) 6 - 12 months
Blood Pressure (marker of hypertension risk)
Change in Adolescent Waist Circumference (WC) 0 - 6 months
Waist circumference (measure of weight control)
Change in Adolescent Waist Circumference (WC) 0 - 12 months
Waist circumference (measure of weight control)
Change in Adolescent Waist Circumference (WC) 6 - 12 months
Waist circumference (measure of weight control)

Full Information

First Posted
April 26, 2022
Last Updated
August 24, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05356884
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, American Samoa, Adolescent, Pacific Islander

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Leadership & Life Skills
Arm Type
Active Comparator
Arm Description
12-session leadership and life skills intervention focusing on adolescent self-esteem, self-efficacy, communication skills, mindfulnesss, healthy habits.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Intervention
Intervention Description
A 12-session group-based intervention that will target diabetes knowledge and leadership and communication skills through facilitated discussion and experiential learning.
Intervention Type
Behavioral
Intervention Name(s)
Leadership & Life Skills
Intervention Description
A 12-session group based intervention that will teach leadership and life skills (planning strategies, leadership values, emotional awareness, effective reasoning skills)
Primary Outcome Measure Information:
Title
Change in Adult Glycemic Control (HbA1c) 0-6 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
0 - 6 months
Title
Change in Adult Glycemic Control (HbA1c) 0-12 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
0 - 12 months
Title
Change in Adult Glycemic Control (HbA1c) 6-12 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
6 - 12 months
Title
Change in Adult Body Mass Index (BMI) 0-6 months
Description
Body mass index (measure of weight control)
Time Frame
0 - 6 months
Title
Change in Adult Body Mass Index (BMI) 0-12 months
Description
Body mass index (measure of weight control)
Time Frame
0 - 12 months
Title
Change in Adult Body Mass Index (BMI) 6-12 months
Description
Body mass index (measure of weight control)
Time Frame
6 - 12 months
Title
Change in Adult Blood Pressure (BP) 0 - 6 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
0 - 6 months
Title
Change in Adult Blood Pressure (BP) 0 - 12 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
0 - 12 months
Title
Change in Adult Blood Pressure (BP) 6 - 12 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
6 - 12 months
Title
Change in Adult Waist Circumference (WC) 0 - 6 months
Description
Waist circumference (measure of weight control)
Time Frame
0 - 6 months
Title
Change in Adult Waist Circumference (WC) 0 - 12 months
Description
Waist circumference (measure of weight control)
Time Frame
0 - 12 months
Title
Change in Adult Waist Circumference (WC) 6 - 12 months
Description
Waist circumference (measure of weight control)
Time Frame
6 - 12 months
Secondary Outcome Measure Information:
Title
Change in Adolescent Glycemic Control (HbA1c) 0 - 6 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
0 - 6 months
Title
Change in Adolescent Glycemic Control (HbA1c) 0 - 12 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
0 - 12 months
Title
Change in Adolescent Glycemic Control (HbA1c) 6 - 12 months
Description
Glycated hemoglobin (marker of long term glycemic control)
Time Frame
6 - 12 months
Title
Change in Adolescent Body Mass Index (BMI) 0 - 6 months
Description
Body mass index (measure of weight control)
Time Frame
0 - 6 months
Title
Change in Adolescent Body Mass Index (BMI) 0 - 12 months
Description
Body mass index (measure of weight control)
Time Frame
0 - 12 months
Title
Change in Adolescent Body Mass Index (BMI) 6 - 12 months
Description
Body mass index (measure of weight control)
Time Frame
6 - 12 months
Title
Change in Adolescent Blood Pressure (BP) 0 - 6 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
0 - 6 months
Title
Change in Adolescent Blood Pressure (BP) 0 - 12 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
0 - 12 months
Title
Change in Adolescent Blood Pressure (BP) 6 - 12 months
Description
Blood Pressure (marker of hypertension risk)
Time Frame
6 - 12 months
Title
Change in Adolescent Waist Circumference (WC) 0 - 6 months
Description
Waist circumference (measure of weight control)
Time Frame
0 - 6 months
Title
Change in Adolescent Waist Circumference (WC) 0 - 12 months
Description
Waist circumference (measure of weight control)
Time Frame
0 - 12 months
Title
Change in Adolescent Waist Circumference (WC) 6 - 12 months
Description
Waist circumference (measure of weight control)
Time Frame
6 - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola L Hawley, PhD
Phone
+1 203 737 7176
Email
nicola.hawley@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola L Hawley, PhD
Organizational Affiliation
Yale University School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
OLaGA Research Center
City
Pago Pago
Country
American Samoa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Naseri
Phone
684 254 5277
Email
joshua.naseri@yale.edu
First Name & Middle Initial & Last Name & Degree
Noelle Potoa'e-Solaita
Phone
684 272 1417
Email
noelle.potoa'e-solaita@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data may be shared with other researchers for the purpose of analyses agreed upon with the Principal Investigator
IPD Sharing 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.
IPD Sharing Access Criteria
All materials will be made publicly available.
IPD Sharing URL
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0279084

Learn more about this trial

Adolescent-mediated Family Diabetes Intervention: American Samoa

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