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ENROLLING BY INVITATION
NCT07377266
NA

The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of the Child With Diabetes, Training in Calmness Around Diabetes Management, Healthy Lifestyle, and Creating Peer-to-peer Networks

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

Summary

The goal of StenoChild is to strengthen the treatment of children under 10 years old with diabetes through a multi-component approach. This includes play-based methods, a focus on nutrition and mental health, and peer-to-peer programs that facilitate parental support and learning. The project has both a clinical and organizational dimension, as it aims to improve diabetes care and change practices and task organization at Steno Diabetes Center Copenhagen, SDCC.

Key Details

Gender

All

Age Range

3 Years - 10 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-04-01

Completion Date

2028-12-31

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

Group consultations and peer-to-peer learning

The intervention introduces strategies to promote structured meals, calmness, and balanced diabetes self-management using play and storytelling learning strategies. Families participate in interactive modules in small groups (\~6-8 families), covering topics like "Meal Calmness" and "Calm Mind" four times during a year (every third month). Parents learn practical techniques to reduce conflict and improve dialogue around diabetes management. Children under 7 receive play-based sessions; those 7 and older receive story-based sessions. Clinical data as well as questionnaires will be collected at each session.

OTHER

Standard Care (in control arm)

The control group receives standard care, with the intervention offered later in a waitlist design. Clinical data as well as questionnaires will be collected at baseline and again after one year.

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Denmark