NCT06670625Recruiting
Intensive Dietary and Activity Counselling (IDAC)
Intensive Dietary and Activity Counselling
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1244 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 15 Mar 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Lund University
- Diseases
- Type 1 diabetes
- NCT number
- NCT06670625
What you commit to
- Study type: Interventional
- Planned participants: 1244
- From 15 Mar 2025 to the primary completion date, 31 Dec 2028
- 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
- Any medical condition, concomitant disease or treatment that may interfere with the assessments or may jeopardize the participant's safe participation in the study, as judged by the investigators.
- Diagnosis of diabetes prior to recruitment or randomization.
- Current use of any investigational drug.
Other illness
- Any condition that could be associated with poor compliance.
Other
- Preterm delivery \< 36 weeks of gestation.
Who the study is looking for
- The age of the infant at time of enrolment should be 3.0 months (13 - 17 weeks).
- An increased genetic risk (7-10%) to develop beta-cell autoantibodies by the age of 6 years.
- Genetic inclusion criteria: Children without a T1D-FDR having HLA DR3/DR4-DQ8, DR4-DQ8/DR4-DQ8 or DR4-DQ8/DR4-DQ7 rs6901541 C/T genotype and:
- for males having a genetic risk score greater than or equal to 18.2 but excluding those who are eligible for AVANT1A.
- for females having a genetic risk score greater than or equal to 14.5 but excluding those who are eligible for AVANT1A.
- Children with a T1D-FDR, all DR3/3, DR4-DQ8/DR4-DQ7 and DR4-DQ8/x where x is none of the following protective alleles: DRB1\*1501, DQB1\*0503, DRB1\*1303 will be included regardless of genetic risk score.
- \- Written informed consent signed by the custodial parent(s).
Age in the registry: 3 months to 4 months · Sex: All · Does not accept 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 |
|---|---|---|---|
| Clinical Research Center (CRC), Bldng 60:11 Coordinator of this site? Confirm its status | Malmö | Sweden | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.