RecruitingNot ApplicableNCT06670625

Intensive Dietary and Activity Counselling (IDAC)

Intensive Dietary and Activity Counselling


Sponsor

Lund University

Enrollment

1,244 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this intervention study is to investigate if a intensive dietary and physical activity counselling during the first two years of life in children with increased (genetically) risk for Type 1 Diabetes (T1D) can promote a healthy beta-cell environment, in order to reduce increased weight gain and development of islet autoimmunity (beta-cell autoantibodies). The main hypotheses are: * Early lifestyle influences the susceptibility to islet autoimmunity (IA) by increasing beta-cell vulnerability. Introducing a "healthy beta-cell lifestyle" from infancy will reduce beta-cell vulnerability and the likelihood of IA. * Will promotion of a healthy beta-cell environment during early childhood in children with increased genetic risk of T1D reduce beta-cell stress, increased weight gain and development of islet autoantibodies? The primary objective is to determine whether an Intensive Diet and Activity Counseling (IDAC) from age 3 months to age 2 years improves beta-cell health in children with increased risk for islet autoimmunity. Secondary objectives are to determine whether IDAC is associated with infant and early childhood growth and body composition and to determine whether IDAC reduces the cumulative incidence of islet autoantibodies or type 1 diabetes in childhood. Participants will be randomized (ratio 1:1) to control group and intervention group. Breastfeeding status at time of randomization will be taken into account. Participants will be enrolled by the age of four months and visit the research clinic ever third months up until the age of 24 months, and then yearly up until the age of 6 years. * Anthropometric measurements and blood draw will be taken at each visit. * Questionnaires focusing on breastfeeding and early infant feeding habits will be used at each visit. * 24hrs recalls will be done at the age of 6, 9, 12, 18 and 24 months of age. * Physical activity will be estimated using questionnaires (3, 6, 9 months) and accelerometer data (12, 18 and 24 months). * Stool samples will be collected at 6, 12 and 18 months of age


Eligibility

Min Age: 3 MonthsMax Age: 4 Months

Plain Language Summary

Simplified for easier understanding

This study (IDAC) tests whether intensive dietary and physical activity counseling for parents can lower the risk of type 1 diabetes developing in infants who have a high genetic risk for the condition. Participants are infants aged around 3 months who carry specific gene variants associated with type 1 diabetes. **You may be eligible if...** - Your infant is approximately 3 months old (13–17 weeks) - Your infant has a high genetic risk for type 1 diabetes based on specific gene variants (HLA genotypes and/or risk score) - You have given written consent as a parent or guardian **You may NOT be eligible if...** - Your baby was born prematurely (before 36 weeks) - Your baby has already been diagnosed with diabetes - Your baby has a medical condition that could interfere with the study - Your baby is currently enrolled in another investigational study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIDAC+

Diet and physical activity counselling at baseline, 6, 12 and 24 months visit.


Locations(1)

Clinical Research Center (CRC), Bldng 60:11

Malmö, Sweden

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NCT06670625


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