Building Blocks - a trial of home visits for first time mothers

ISRCTN	ISRCTN23019866
DOI	https://doi.org/10.1186/ISRCTN23019866
Protocol serial number	Version 1.4
Sponsor	Department of Health (UK)
Funder	Department of Health (UK) (ref: 006/0060) - Policy Research Programme

Submission date: 24/03/2009
Registration date: 20/04/2009
Last edited: 29/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mike Robling
Scientific

Director South East Wales Trials Unit
Department of Primary Care and Public Health
7th Floor Neuadd Meirionnydd
Cardiff University
Heath Park
Cardiff
CF14 4YS
United Kingdom

Study information

Primary study design	Interventional
Study design	Individually randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Evaluating the family nurse partnership programme in England: a randomised controlled trial
Study acronym	Building Blocks
Study objectives	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
Ethics approval(s)	Research Ethics Committee (REC) for Wales, 17/02/2009, ref: 09/MRE09/08
Health condition(s) or problem(s) studied	First-time pregnancy
Intervention	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.
Intervention type	Other
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
Key secondary outcome measure(s)	1. Intention to breastfeed 2. Prenatal attachment 3. Injuries and ingestions 4. Breastfeeding (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.
Completion date	19/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1600
Total final enrolment	1645
Key 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
Key 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
Date of first enrolment	25/06/2009
Date of final enrolment	28/07/2010

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

South East Wales Trials Unit (SEWTU)

Institute of Primary Care and Public Health
Cardiff University
7th Floor Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/01/2016		Yes	No
Results article	results	20/09/2016		Yes	No
Results article	results	05/05/2018	14/05/2019	Yes	No
Results article		23/09/2022	29/09/2022	Yes	No
Protocol article	protocol	06/08/2013		Yes	No
Other publications	analysis	30/12/2019	02/01/2020	Yes	No
Other publications	economic evaluation	13/09/2019	04/06/2020	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

29/09/2022:Publication reference added.
04/06/2020: Publication reference added.
02/01/2020: Publication reference added.
14/05/2019: Publication reference and total final enrolment added.
26/06/2016: publication reference added.
13/01/2015: the following changes were made to the trial record:
1. The overall trial end date was changed from 31/01/2013 to 19/09/2014.
2. The target number of participants was changed from 2400 to 1600.