Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05356884
Study type Interventional
Source Yale University
Contact
Status Active, not recruiting
Phase N/A
Start date July 7, 2022
Completion date August 31, 2024

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2