Condition category
Pregnancy and Childbirth
Date applied
28/03/2011
Date assigned
28/03/2011
Last edited
01/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof S C Robson

ORCID ID

Contact details

Newcastle University
Newcastle
NE2 4HH
United Kingdom
-
s.c.robson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9863

Study information

Scientific title

Optimising Baby to Breast Attachment (OBBA): a mixed method study

Acronym

OBBA

Study hypothesis

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

Newcastle & North Tyneside 1 Research Ethics Committee. Original approval given 20/01/2011. Amendment No 1 (08/02/2011) approval given 21/02/2011

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 188; UK Sample Size: 188

Participant 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

Recruitment start date

01/03/2011

Recruitment end date

01/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Doctor Research Fellowship

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

01/02/2016: No publications found, verifying study status with principal investigator