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

Not Applicable

Completed

• Conditions: First-time pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN23019866
• Lead Sponsor: Department of Health (UK)

Brief Summary

2013 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/23919573 protocol 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26474809 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27660554 results 2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29730623 results (added 14/05/2019) 2019 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/31888752 analysis (added 02/01/2020) 2019 Other publications in https://pubmed.ncbi.nlm.nih.gov/31632654/ economic evaluation (added 04/06/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36151554/ (added 29/09/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-20
• Study Completion: 2014-09-19
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1645

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Changes in prenatal tobacco use (maternal measure), measured at baseline and 34 - 36 weeks gestation interviews<br> 2. Birth weight (child measure), measured at birth (collected afterwards)<br> 3. Emergency attendances/admissions within two years of birth, measured at all timepoints<br> 4. Proportion of women with a second pregnancy within two years of first birth, measured at all timepoints<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Intention to breastfeed<br> 2. Prenatal attachment<br> 3. Injuries and ingestions<br> 4. Breastfeeding (initiation and duration)<br> 5. Language development<br> 6. Education<br> 7. Employment<br> 8. Income/benefits<br> 9. Home (tenure)<br> 10. Health status<br> 11. Self-efficacy<br> 12. Social support<br> 13. Paternal involvement<br><br> Timepoints not finalised as of 24/03/2009.<br>