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Intensive Dietary and Activity Counselling (IDAC)

Study acronym: IDAC
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Enrollment target: 800 to 1244
    • Study description revised
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Eligibility criteria expanded, about 15 words
    • Site details revised
    v3
  3. Notable Start date: Jan 15, 2025 to Mar 15, 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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
Trial Details
NCT Number NCT06670625
Lead Sponsor Lund University
Conditions
(from sponsor)
Type 1 Diabetes, Autoimmune Diabetes
Related terms Diabetes Mellitus, Type 1
Enrollment 1,244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov