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Little in Norway (LiN) study

A longitudinal population study of infant vulnerability and plasticity from pregnancy to age 18 months

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN66710572
Enrollment
1036
Registered
2018-05-09
Start date
2011-10-01
Completion date
Unknown
Last updated
2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child development Not Applicable

Interventions

The overarching objective of the present project is to investigate how very young Norwegian children fare in the sensory-motor and social-emotional domains, and how susceptible childre

Sponsors

University of Oslo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pregnant women were enrolled from September 2011 to October 2012 2. All pregnant women receiving routine prenatal care at well-baby clinics at nine geographically diverse sites across Norway were invited by midwives to participate 3. Most pregnant women were at week 11-26 into gestation when they completed the first questionnaire; however, some women were asked as late as week 31-34

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
Child outcome and possible diagnostic information based on repeated observations of parent–child interaction, developmental testing, and parent and preschool teacher report measures: Data collection in the Little in Norway study has comprised five points in pregnancy (weeks 16, 20, 26, 32, 36), time of birth, 6 weeks postpartum, 6,12 and 18 months and 3 years. Data have been collected through self-report questionnaires filled out at home, at well baby clinics or completed by research assistants based on parent interviews, and by testing and observation of the child, telephone interviews and video sessions. All completed questionnaires, test protocols and video recordings were streamed to a central facility where they were registered, verified and kept on a secure server. The questionnaires that were completed at home used a web-based survey motor provided by one of the study’s data processors. A comprehensive questionnaire package was given to the participating mothers and fathers at the first meeting in pregnancy, which could take place from pregnancy week 8 to 34, depending on the specific time of enrolment. The questionnaire package included queries concerning sociodemographic background, smoking, use of alcohol, drugs and medication in pregnancy, as well as the following measures: 1. The Life Stress Scale (a subscale of the Parenting Stress Index, PSI), measuring parental stress factors over the previous 12 months 2. The Pregnancy Related Anxiety Questionnaire (PRAQ R), designed to assess anxiety related to pregnancy and birth 3. The Edinburgh Postnatal Depression Scale (EPDS), a self-report measure identifying women at risk for perinatal depression 4. The Adverse Childhood Experience Scale (ACE), assessing possible parental adverse childhood experiences prior to age 18 years For all but the latest enrolled families, most of the procedures applied at

Secondary

MeasureTime frame
1. Dietary intake was assessed using a web-based, semi-quantitative food frequency questionnaire, the Seafood-FFQ. The questionnaire is designed to capture the habitual intake of seafood and the use of dietary supplements. To enable aggregation and quantity estimation of individual seafood consumption, ordinal data from the Seafood-FFQ is converted to numerical data using the seafood-index system. At 3 years a web-based FFQ of mothers and children's food habits was applied. 2. Nutritional status and suboptimal nutritional status of micronutrients like DHA, vitamin D and iodine, assessed using hair, urine, and blood samples collected repeatedly through follow-up (at inclusion in pregnancy, 6 weeks, 6 months, 12 months and 18 months) 3. Cortisol level measured using hair samples from mothers 6 weeks and 12 months postpartum 4. DNA methylation assayed using saliva samples collected by the research assistants at 6 weeks and 12 months (from the child and the mother)

Countries

Norway

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026