REAL-Fam Feasibility Study for Youth Diabetes Management (NCT07212790)
Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if the REAL-Fam occupational therapy intervention is feasible to study in a larger-scale randomized controlled trial. It will also seek to understand how the intervention influences how a rural family participates in and manages their child's type 1 diabetes, their family quality of life, and the child's health outcomes. The main questions it aims to answer are: * Primary Aim 1: Evaluate the recruitment capability, participant inclusion criteria, assessment selection and process, and data. * Primary Aim 2: Evaluate the participant acceptability of and interventionist fidelity to the intervention. * Secondary Aim: Evaluate families' preliminary outcomes to the REAL-Fam on family quality of life and participation, diabetes management self-efficacy, and child blood glucose stability. Researchers will compare the REAL-Fam intervention to the Attention Group to see if there are changes in family diabetes-related health routines and psychosocial aspects of managing a child's type 1 diabetes. Participants will: * Children will wear continuous glucose monitors for study period * Caregiver participants will complete baseline and post-intervention surveys * Intervention Group: engage in 12 audio/video telehealth sessions with REAL-Fam intervention * Attention Group: engage in 3 audio/video Zoom meetings without specialized services * Complete a post-study interview
Who can join: Review the eligibility criteria below.
Location: The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
Age range: 2 Years to 99 Years
🧪 Interventions in This Study
- REAL-Fam Occupational Therapy Family Coaching (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes
- A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D) — Hershey, Pennsylvania
- Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families — Jacksonville, Florida
- Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes — Cleveland, Ohio
- GO TEAM: Glucose Optimization Through Technology Assisted Management — Cleveland, Ohio
- Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes — New York, New York
Explore by condition: All Type 1 Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.