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Building Blocks - a trial of home visits for first time mothers
ISRCTN ISRCTN23019866
DOI 10.1186/ISRCTN23019866
ClinicalTrials.gov identifier
EudraCT number
Public title Building Blocks - a trial of home visits for first time mothers
Scientific title Evaluating the family nurse partnership programme in England: a randomised controlled trial
Acronym Building Blocks
Serial number at source Version 1.1
Study hypothesis The purpose of this study is to see if providing young first time mothers with extra support before and after the birth is helpful for both mother and child. We are specifically interested in whether the programme makes a difference to the mother and baby's health and behaviour:
1. During pregnancy and at birth
2. In the first two years after birth
Lay summary
Ethics approval Research Ethics Committee (REC) for Wales gave approval on the 17th February 2009 (ref: 09/MRE09/08)
Study design Individually randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain First time pregnancy
Participants - inclusion criteria 1. Women aged 19 years or under (at recruitment/consent)
2. Lives within the catchment area covered by the local family nurse partnership (FNP) team
3. First pregnancy confirmed by health services (including those expecting multiple birth) unless previous pregnancy ended in miscarriage, stillbirth or termination
4. Recruited no later than 24 weeks
5. Gillick competent to provide adequate informed consent to research participation including competence in English at conversational level or higher
Participants - exclusion criteria 1. Women who at study entry, plan to have their child adopted
2. Women who at study entry, plan to leave the FNP area during the time of the trial either for an extended period of time (3 months or longer) or permanently
3. Women who would require a third person (translator, sign interpreter) to receive the FNP programme
Anticipated start date 06/04/2009
Anticipated end date 31/01/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 2400
Interventions This trial will assess the effectiveness of the FNP in England compared with existing universal services, in achieving its stated objectives (namely, to improve pregnancy outcomes, child health and development and parents' economic self-sufficiency).

The trial will start after consent and recruitment into the trial. Participants will be recruited into the trial as soon as the pregnancy is confirmed but before 24 weeks gestation. Participants will be randomised to either entry into the FNP programme arm or to the control arm (universal services), and will be followed up until 2 years after the birth of the child. The whole trial will last 52 months. Interviews (either face-to-face or by telephone) for both arms of the trial will be at baseline, 34 - 36 weeks gestation and 6, 12, 18 and 24 months after birth.

If participants are selected to join the group that receives the FNP programme, they will receive visits from a specially trained 'Family Nurse'. The Family Nurse would normally go to the participants' home, but can see you somewhere else if they prefer. The Family Nurse will visit the participant every week for the first month after they join the study, and then every other week until the baby is born. The Family Nurse will then visit the participant weekly until the baby is six weeks old and then once every two weeks until the child is 20 months old. The last four visits are monthly until the child is 2 years old.
Primary outcome measure(s) 1. Changes in prenatal tobacco use (maternal measure), measured at baseline and 34 - 36 weeks gestation interviews
2. Birth weight (child measure), measured at birth (collected afterwards)
3. Emergency attendances/admissions within two years of birth, measured at all timepoints
4. Proportion of women with a second pregnancy within two years of first birth, measured at all timepoints
Secondary outcome measure(s) 1. Intention to breastfeed
2. Prenatal attachment
3. Injuries and ingestions
4. Breast feeding (initiation and duration)
5. Language development
6. Education
7. Employment
8. Income/benefits
9. Home (tenure)
10. Health status
11. Self-efficacy
12. Social support
13. Paternal involvement

Timepoints not finalised as of 24/03/2009.
Sources of funding Department of Health (UK) (ref: 006/0060) - Policy Research Programme
Trial website http://www.cardiff.ac.uk/medic/subsites/buildingblocks/index.html
Publications
Contact name Dr  Mike  Robling
  Address Associate Director South East Wales Trials Unit
Department of Primary Care and Public Health
7th Floor Neuadd Meirionnydd
Cardiff University
Heath Park
  City/town Cardiff
  Zip/Postcode CF14 4YS
  Country United Kingdom
Sponsor Department of Health (UK)
  Address Policy Research Programme
Research and Development Directorate
NIHR CCF PO Box 407
Teddington, Middlesex
  City/town Teddington
  Zip/Postcode TW11 0XX
  Country United Kingdom
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 24/03/2009
Last edited 20/04/2009
Date ISRCTN assigned 20/04/2009
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