Actively Recruiting
Family mHealth Intervention to Improve Health Outcomes in Black Youth With Type 1 Diabetes
Led by Wayne State University · Updated on 2025-07-15
216
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wayne State University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of The 3Ms 2.0, a mobile health (mHealth) family intervention, compared to an educational control for improving blood sugar control and family relationships related to diabetes among Black adolescents aged 10 to 14 years with type 1 diabetes and their primary caregivers. This multi-center randomized controlled trial aims to reduce caregiver distress and enhance diabetes management through culturally tailored content delivered via mobile devices. Participants will be randomly assigned to receive either The 3Ms 2.0 intervention or an educational attention control, both alongside standard medical care. The 3Ms 2.0 program includes three brief computer-delivered sessions for caregivers, featuring interactive narration, skill demonstration videos, and text reminders over a three-month period, with follow-ups accessible monthly. The control group will also receive three informational sessions on diabetes-related topics within a six-month access window. Families will provide data at home or online at baseline, 3 months, 6 months, and 12 months after starting. Assessments include questionnaires on diabetes management, parental supervision, family dynamics, and quality of life, along with blood samples to measure HbA1c for blood sugar levels and medical record reviews. The study will analyze all participants' data regardless of intervention completion to evaluate the impact on glycemic control and family well-being over one year.
CONDITIONS
Brief Title
Family Intervention for Black Teens With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 years, 0 months and 14 years, 11 months
- Diagnosed with Type 1 diabetes for at least 6 months
- Identifies as Black
- Primary caregiver willing to participate
- Lives within 30 miles of a recruitment site
- Caregiver owns an internet-enabled device such as a cell phone, laptop, desktop, or tablet
You will not qualify if you...
- Mental health conditions that could affect data quality, including developmental delay, schizophrenia, psychosis, current suicidality, or homicidality
- Co-existing medical conditions causing unusual diabetes management, such as cystic fibrosis
- Inability to speak or read English
- Child is in out-of-home placement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 months
Participants receive either The 3Ms 2.0 mHealth intervention or an educational attention control condition, both delivered via mobile device, alongside standard medical care.
Data collection at baseline, 3 months, and 6 months; intervention sessions accessible during this time
Duration - 6 months after treatment ends
Participants complete additional assessments 12 months after baseline to evaluate longer-term outcomes.
1 visit (in-person or remote) at 12 months post-baseline
Trial Site Locations
Total: 4 locations
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Wayne Pediatrics
Detroit, Michigan, United States, 48201
Actively Recruiting
3
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38103
Actively Recruiting
4
University of Tennessee Health Science Center-Memphis
Memphis, Tennessee, United States, 38163
Actively Recruiting
Research Team
D
Deborah A Ellis, Ph.D.
J
Jillian T Sjostrom, B.S.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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