Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/09/2017
Date assigned
23/10/2017
Last edited
22/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

https://www.ucd.ie/lifeways/

Contact information

Type

Public

Primary contact

Prof Cecily Kelleher

ORCID ID

http://orcid.org/0000-0001-9548-4914

Contact details

UCD School of Public Health
Physiotherapy and Sport Science
Woodview House
Belfield
Dublin
D04 V1W8
Ireland
+353 (0)1890 202 502
lifeways@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0

Study information

Scientific title

Lifeways: to study the influence of socio-economic and familial characteristics on the health status and early-life development of children in Ireland

Acronym

Lifeways

Study hypothesis

To 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

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

Study design

Observational longitudinal cross-generation cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Patient information sheets from each sweep of data collection can be accessed on the project website.

Condition

General health

Intervention

Participating 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 type

Other

Phase

Drug names

Primary outcome measure

Child Body Mass Index at 5 years old

Secondary outcome measures

1. 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 trial start date

01/01/2000

Overall trial end date

01/01/2038

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

1000 mothers during pregnancy, their child/children from that pregnancy, their husband/partner, and at least one living grandparent of the child/children

Participant exclusion criteria

Mothers born outside Ireland

Recruitment start date

02/10/2001

Recruitment end date

04/04/2003

Locations

Countries of recruitment

Ireland

Trial participating centre

Coombe Women and Infant's Hospital
Cork Street
Dublin
D08 XW7X
Ireland

Trial participating centre

University Hospital, Galway
Newcastle Road
Galway
H91 YR71
Ireland

Sponsor information

Organisation

Health Research Board, Ireland

Sponsor details

Grattan House
67-72 Lower Mount Street
Dublin
D02 H638
Ireland
+353 (0)1 2345000
hrb@hrb.ie

Sponsor type

Government

Website

www.hrb.ie

Funders

Funder type

Research council

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Ireland

Results and Publications

Publication and dissemination plan

Over 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 statement:
The 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.

Intention to publish date

23/10/2018

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30339199

Publication citations

Additional files

Editorial Notes

22/10/2018: Publication reference added. 26/10/2017: Internal review.