Optimising Baby to Breast Attachment (OBBA)

ISRCTN	ISRCTN14646651
DOI	https://doi.org/10.1186/ISRCTN14646651
Secondary identifying numbers	9863

Submission date: 28/03/2011
Registration date: 28/03/2011
Last edited: 28/01/2019

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

Prof S C Robson
Scientific

Newcastle University
Newcastle
NE2 4HH
United Kingdom

Email	s.c.robson@ncl.ac.uk

Study information

Study design	Both; Interventional and Observational; Design type: a) Quantitative (RCT) and b) Qualitative (one to one structured interviews, one to one in-depth interviews, and focus groups)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Optimising Baby to Breast Attachment (OBBA): a mixed method study
Study acronym	OBBA
Study objectives	Phase 1: Refinement of a complex intervention to teach mothers how to Optimise Baby to Breast Attachment (OBBA). Phase 2: RCT - final design determined by findings from phase 1. Women will receive: a. Standard breastfeeding support or b. Standard breastfeeding support plus the intervention Phase 3. Process evaluation a. In-depth interviews with a selection of women from both groups. b. One-to-one interviews with women who decline participation in RCT. c. Focus groups with health professionals.
Ethics approval(s)	Newcastle & North Tyneside 1 Research Ethics Committee. Original approval given 20/01/2011. Amendment No 1 (08/02/2011) approval given 21/02/2011
Health condition(s) or problem(s) studied	Topic: Reproductive Health and Childbirth; Subtopic: Reproductive Health and Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth
Intervention	OBBA, Education session with mothers to teach how to optimising baby to breast attachment; Study Entry : Registration and One or More Randomisations
Intervention type	Other
Primary outcome measure	Breastfeeding duration; Timepoint(s): 6 weeks
Secondary outcome measures	1. Breastfeeding self efficacy 2. Number and type of breastfeeding problems 3. Satisfaction with breastfeeding experience 4. Acceptability of intervention (intervention group only)
Overall study start date	01/03/2011
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 188; UK Sample Size: 188
Key inclusion criteria	1. Mothers whom have delivered a singleton full-term healthy baby more than or equal to 37wks gestation, and more than or equal to 2500g 2. Mothers who initiate breastfeeding prior to discharge from hospital 3. Mothers who have a good command of the English language Target Gender: Female; Upper Age Limit 50 years ; Lower Age Limit 16 years
Key exclusion criteria	1. Women with babies with major congenital anomalies 2. Women whose babies are admitted to the special care baby unit 3. Women unable to converse in the English language will be excluded due to the developmental nature of the study and the large qualitative element and limited resources to translate the intervention, education material and questionnaires
Date of first enrolment	01/03/2011
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Newcastle University

Newcastle
NE2 4HH
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Midwifery Research Dept, Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom

"ROR"	https://ror.org/05p40t847

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Doctor Research Fellowship
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	04/04/2018: Results published in thesis 2014 https://theses.ncl.ac.uk/dspace/bitstream/10443/2828/1/Kelly%2C%20T.A.%202015.pdf
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		21/01/2019	24/01/2019	No	No

Additional files

ISRCTN14646651_BasicResults_21Jan19.pdf: Uploaded 24/01/2019

Editorial Notes

28/01/2019: IPD sharing statement added.
24/01/2019: The basic results of this trial have been uploaded as an additional file.
04/04/2018: Thesis added to publication and dissemination plan. PI informed there will be no other publications.
28/03/2018: No publications found, verifying study status with principal investigator.
01/02/2016: No publications found, verifying study status with principal investigator