NCT07212790Active, not recruiting
REAL-Fam Feasibility Study for Youth Diabetes Management
Feasibility of REAL-Fam to Support Diabetes Self-Management, Family Participation, and Child Health
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 22 Sept 2025
- Start date
- 15 Dec 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Type 1 diabetes
- NCT number
- NCT07212790
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 15 Dec 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If the child is currently receiving occupational therapy services;
Other illness
- Caregiver who is not completing any supervision/support for their child's diabetes management;
Other
- Has a severe developmental, intellectual, or neurological disability
Who the study is looking for
- Caregiver over 19 years old and designated guardian or parent to a child living with Type 1 Diabetes;
- Live in a rural area over 1 hour from pediatric endocrinology care team;
- Access to reliable internet
Age in the registry: 2 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.