ISRCTN ISRCTN16537904
DOI https://doi.org/10.1186/ISRCTN16537904
Secondary identifying numbers 0
Submission date
15/09/2017
Registration date
23/10/2017
Last edited
12/12/2019
Recruitment status
No longer recruiting
Overall study status
Ongoing
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Many factors, including genetic, environmental and lifestyle, affect the way children grow and continue to develop into adulthood and later life. Over the last 20 years or so, many birth cohort studies have been established in various countries, tracking the health status of children from birth, and attempting to determine the combination of physical and environmental factors that influence their long-term health status. The Lifeways cross-generation cohort study was established in 2001 to perform this function in an Irish context, and furthermore to look at grand-parental as well as parental influences on childhood development.

Who can participate?
Mothers during pregnancy, their subsequent child/children, the father and grandparents of the child.

What does the study involve?
Mothers who consent to participate are asked to complete a comprehensive health and lifestyle questionnaire, and to grant access to their hospital records and those of their child. The consenting fathers and grandparents complete a similar comprehensive health and lifestyle questionnaire, with the grandparents also being invited to undertake a simple physical exam, measuring height, weight and blood pressure, and to provide a blood sample to determine cholesterol levels. At child aged 3 years, family doctors are requested to complete a health questionnaire on all consenting participants (children, parents, grandparents) attending their health service. At child aged 5 years, the child and parents are invited to undertake a physical exam, measuring height, weight and waist circumference, and the mothers are asked to complete another comprehensive health and lifestyle questionnaire on behalf of herself, her child and her family. At child aged 9 years, the mothers and children are again invited to undertake a physical exam, measuring height, weight and waist circumference. Grandparents are also invited to a similar physical exam, but are furthermore asked to provide a blood sample to determine cholesterol levels. Parents and grandparents are also asked to complete a shortened health questionnaire at this time. At this follow-up time, children, parents and grandparents were also asked to provide a sample of hair and saliva. Finally, as this follow-up time, family doctors are requested to complete a health questionnaire on all consenting participants (children, parents, grandparents) attending their health service. As the children continue to age, further follow-up of the study participants is planned, involving similar physical exams and health and lifestyle questionnaires.

What are the possible benefits and risks of participating?
There are no direct benefits or risks (other than the general risks relating to blood tests) in taking part in this study, but the results of the study may help improve the health of families and children in Ireland.

Where is the study run from?
1. Coombe Women and Infant's Hospital (Italy)
2. University Hospital, Galway (Italy)

When is the study starting and how long is it expected to run for?
January 2000 to January 2038

Who is funding the study?
Health Research Board (Ireland)

Who is the main contact?
Professor Cecily Kelleher
lifeways@ucd.ie

Study website

Contact information

Prof Cecily Kelleher
Public

UCD School of Public Health, Physiotherapy and Sport Science
Woodview House
Belfield
Dublin
D04 V1W8
Ireland

ORCiD logoORCID ID 0000-0001-9548-4914
Phone +353 (0)1890 202 502
Email lifeways@ucd.ie

Study information

Study designObservational longitudinal cross-generation cohort study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Hospital
Study typeOther
Participant information sheet Patient information sheets from each sweep of data collection can be accessed on the project website.
Scientific titleLifeways: to study the influence of socio-economic and familial characteristics on the health status and early-life development of children in Ireland
Study acronymLifeways
Study objectivesTo establish a longitudinal birth cohort in Ireland, including cross-generation information on children, their parents and grandparents:
1. To record the physical and psychological health status and socio-economic circumstances of individuals at birth, during early childhood, early adulthood and early middle age in Ireland
2. To follow them prospectively in order to measure their changing health status, and to assess the extent to which health status relates to social circumstances
Ethics approval(s)Baseline:
Coombe Women and Infant’s Hospital, Dublin, 10/12/2001
University College Hospital, Galway (UCHG); National University of Ireland, Galway (NUIG), 23/09/2000 and 22/02/2001
Irish College of General Practitioners (ICGP), 16/10/2001 and 13/05/2002

Year-3 follow-up:
ICGP, UCHG and Coombe Women and Infant's Hospital,16/11/2004 and 13/11/2004

Year-5 follow-up:
University College, Dublin (UCD)- 06/02/2007

Year-10 follow-up:
UCD, 10/02/2011 and 01/02/2012
UCHG, 27/06/2011
Coombe Women and Infant's Hospital, Dublin,04/10/2012
St. Vincent's University Hospital, Dublin (SVUH), 06/12/2012
Health condition(s) or problem(s) studiedGeneral health
InterventionParticipating adults are asked to complete comprehensive health and lifestyle questionnaires, including information on diet (food frequency questionnaire), health and morbidities, exercise, and household and economic circumstances. Questionnaire completion to date has been requested at baseline, year 5 follow-up and year-9 follow up.

Mothers are asked to consent to their hospital records and those of their children be made available to the study team. From these, pregnancy related data is extracted, such as pregnancy complications, child birth-weight and other neo-natal measurements.

All participants are asked to undergo a simple physical exam at least once, either in the home, attending at a specified clinic, or at their family doctor. For children, the primary physical exam is at age 5, with a subsequent exam at age 9.

A blood sample is also requested from participating grandparents at baseline and at year 9 follow-up, and from participating children at age 9 who were happy to do so.

Hair and saliva samples are requested from all participants at year 9 follow-up.

Family doctors of all participants who consented are asked to provide information on the health status of participants attending their practice, including any blood lipid and glucose measurements, and blood pressure measurements. This was undertaken at both year 3 and year 9 follow-up.
Intervention typeOther
Primary outcome measureChild Body Mass Index at 5 years old
Secondary outcome measures1. Child’s birth weight
2. Child’s Body Mass Index at 9 years old
3. Child’s asthma status at 3, 5 and 9 years old
4. Child’s medical services use at 3,5 and 9 years old
Overall study start date01/01/2000
Completion date01/01/2038

Eligibility

Participant type(s)Mixed
Age groupMixed
SexBoth
Target number of participants1000 mothers during pregnancy, their child/children from that pregnancy, their husband/partner, and at least one living grandparent of the child/children
Total final enrolment1882
Key inclusion criteria1. Pregnant women attending ante-natal clinics in two hospitals in Ireland, each representing distinct regions (East and West) of the country
2. Their live-born child/children of the women from that pregnancy
3. The child/children's father
4. At least one living grandparent of the child/chlidren
Key exclusion criteriaMothers born outside Ireland
Date of first enrolment02/10/2001
Date of final enrolment04/04/2003

Locations

Countries of recruitment

  • Ireland

Study participating centres

Coombe Women and Infant's Hospital
Cork Street
Dublin
D08 XW7X
Ireland
University Hospital, Galway
Newcastle Road
Galway
H91 YR71
Ireland

Sponsor information

Health Research Board, Ireland
Government

Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland

Phone +353 (0)1 2345000
Email hrb@hrb.ie
Website www.hrb.ie
ROR logo "ROR" https://ror.org/003hb2249

Funders

Funder type

Research council

Health Research Board
Government organisation / Local government
Alternative name(s)
Health Research Board, Ireland, An Bord Taighde Sláinte, HRB
Location
Ireland

Results and Publications

Intention to publish date23/10/2018
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planOver 20 peer-reviewed journal papers have been published from this cohort. Publication of results is ongoing: as of October 2017, there are currently 4 submitted journal papers undergoing peer review, with a further 3 publications planned in the next 12 months. A full list of publications and presentations is available on the project website. Study instruments and allied data can be accessed on the project website. Please see https://www.ucd.ie/lifeways/research/
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available. This is an observational study linking participant physical examination data, participant questionnaire data and data from the participants’ general medical practitioners. As the study is ongoing, and to comply with the terms of engagement with the general practitioners, there is no plan in the short to medium term to archive the data for public use. The study data is held and managed by the Lifeways Study team at the School of Public Health, Physiotherapy and Sport Science at University College, Dublin, Ireland. Access to the study data is only available through direct collaboration with the Lifeways study team, contactable at lifeways@ucd.ie.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2018 Yes No
Results article results 01/06/2019 Yes No
Results article 10 year follow up results 01/02/2020 12/12/2019 Yes No

Editorial Notes

12/12/2019: Publication reference added.
29/05/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/10/2018: Publication reference added.
26/10/2017: Internal review.