Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for improving adolescent glycemic control and diabetes-related family relationships and reducing primary caregiver diabetes-related distress among Black adolescents with type 1 diabetes (T1D) and their primary caregivers. The proposed study would develop and test The 3Ms 2.0 adapted intervention when delivered using a mobile health approach (accessed via parents' cell phone). The intervention will also include new family intervention content (videoclips and text messages).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 14
Healthy Volunteers: f
View:

• Age: 10 years, 0 months - 14 years, 11 months

• Diagnosed with Type 1 diabetes

• Diagnosed for at least 6 months

• Black

• Primary caregiver willing to participate

• Residence within 30 miles of a recruitment site

• Caregiver ownership of an Internet-enabled device (cell phone, laptop or desktop computer, tablet, etc)

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Michigan
Wayne Pediatrics
RECRUITING
Detroit
Tennessee
LeBonheur Children's Hospital
RECRUITING
Memphis
University of Tennessee Health Science Center-Memphis
RECRUITING
Memphis
Contact Information
Primary
Deborah A Ellis, Ph.D.
dellis@med.wayne.edu
313-577-1055
Backup
Jillian T Sjostrom, B.S.
jrhind@med.wayne.edu
313-577-6997
Time Frame
Start Date: 2024-09-16
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 216
Treatments
Active_comparator: Educational Attention Control (EAC) + Standard Medical Care
Experimental: The 3Ms 2.0 Intervention + Standard Medical Care
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Leads: Wayne State University

This content was sourced from clinicaltrials.gov