Optimising Baby to Breast Attachment (OBBA)
| ISRCTN | ISRCTN14646651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14646651 |
| Protocol serial number | 9863 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Doctor Research Fellowship |
- 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
Scientific
Newcastle University
Newcastle
NE2 4HH
United Kingdom
| s.c.robson@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| 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) |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Breastfeeding duration; Timepoint(s): 6 weeks |
| Key secondary outcome measure(s) |
1. Breastfeeding self efficacy |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Newcastle University
Newcastle
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
