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Intensive Dietary and Activity Counselling (IDAC)

NCT06670625 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1244

Last updated 2026-04-13

No results posted yet for this study

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

Conditions

Interventions

BEHAVIORAL

IDAC+

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

Sponsors & Collaborators

  • Lund University

    lead OTHER

Principal Investigators

  • Helena Elding Larsson, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2028-12-31
Completion
2031-12-31

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670625 on ClinicalTrials.gov