Little in Norway (LiN) study
| ISRCTN | ISRCTN66710572 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66710572 |
| Protocol serial number | Norwegian Research Council Grant #196156 |
| Sponsor | University of Oslo |
| Funder | Norges Forskningsråd |
- Submission date
- 20/03/2018
- Registration date
- 09/05/2018
- Last edited
- 23/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The aim of this study is to investigate risk factors before and after birth that affect early childhood emotional regulation and development from pregnancy to child age 3 years.
Who can participate?
Pregnant women receiving routine prenatal care at well-baby clinics at nine sites across Norway
What does the study involve?
Data is collected at five points in pregnancy, birth, and five follow-up points up to age 3. Questionnaires are completed by both parents, hair, urine, blood and saliva samples are taken from the mother and child, there are direct observations and testing of the children, and videotaping of parent–child interaction. Questionnaires about infant behaviour and development and parental mental health and diet are filled out when the families attend the site, and web-based forms are completed from home.
What are the possible benefits and risks of participating?
A possible benefit for the parents and their children is that their development is followed closely and with the opportunity to refer them to the relevant services if and when there is a need for such referrals. Attending all the follow-ups in the study may be time-consuming for the parents. Concerning blood samples only experienced nurses are employed to heighten security. In addition, all participants are told that the blood sampling is voluntary and that they could take part in the study without going through the blood sampling.
Where is the study run from?
University of Oslo (Norway)
When is the study starting and how long is it expected to run for?
January 2010 to December 2016
Who is funding the study?
Research Council of Norway
Who is the main contact?
Dr Vibeke Moe
Contact information
Scientific
Department of Psychology
University of Oslo
PO Box 1094 Blindern
Oslo
0317 Oslo
Norway
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective longitudinal multisite community-based study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | A longitudinal population study of infant vulnerability and plasticity from pregnancy to age 18 months |
| Study acronym | LiN |
| Study objectives | The study aims to acquire new knowledge of critical factors affecting early childhood emotional regulation and development, as well as to gain better understanding of mechanisms and differential biological plasticity related to infant mental health outcome. |
| Ethics approval(s) | Norwegian Regional Committees for Medical and Health Research Ethics, 24/05/2011, ref: 2011/560 |
| Health condition(s) or problem(s) studied | Child development |
| Intervention | 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 children may be adversely affected by stressors and potentially benefit from intervention: (1) Who are the most susceptible to delayed sensory-motor development and emotional adversity? And (2) who will potentially benefit from intervention? The study aims to assess a wide array of environmental stress, including both biomedically and environmentally mediated stressors as well as parent-reported stress factors. Susceptibility and resilience will be studied by examining child development over time related to externalizing internalizing behaviors (e.g. anxiety) and emotion dysregulation. Outcome measures will cover a wide range of possible sequelae. Pre- and postnatal risk factors influencing developmental plasticity are investigated from pregnancy to age 18 months. A web-based questionnaire is also distributed at child age 3 years. Data collection phases comprised five points in pregnancy, birth, and five follow-up points up to age 3. The main categories of data include questionnaires completed repeatedly by both parents, biological samples of mother and child, direct observations and testing of the children, and videotaping of parent–child interaction. Questionnaires related to infant behavior and development as well as to parental mental health and dietary intake were filled out when the families attended the site, and as web-based forms from home. Biological samples include saliva, hair, urine and blood samples. |
| Intervention type | Other |
| Primary outcome measure(s) |
Child outcome and possible diagnostic information based on repeated observations of parent–child interaction, developmental testing, and parent and preschool teacher report measures: |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 1036 |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 01/10/2012 |
Locations
Countries of recruitment
- Norway
Study participating centre
0317 Oslo
Norway
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | The type of data stored are SPSS files, as well as video recordings of parent-infant interactions, in addition to biological samples. At inclusion each participant (mother and father) was informed about the purpose of the study. Confidentiality was assured, and it was emphasized that participation was voluntary and could be withdrawn at any time. The study protocol and the assessment procedures were reviewed and approved by the Norwegian Regional Committees for Medical and Health Research Ethics, reference number 2011/560. All procedures were in accordance with these ethical standards and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Parts of the data are highly sensitive and may be identifiable, there is therefore presently both ethical and legal restrictions concerning accessibility. The ethics approval state that data shall be stored until 2030. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/12/2019 | 23/11/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/11/2020: Publication reference added.