Optimising Baby to Breast Attachment (OBBA) | Not Recruiting
Optimising Baby to Breast Attachment (OBBA)
OBBA
Trial Source

Health Conditions
  • Topic: Reproductive Health and Childbirth
  • Subtopic: Reproductive Health and Childbirth (all Subtopics)
  • Disease: Reproductive Health & Childbirth
Not Recruiting
Recruitment Status
ISRCTN14646651
Primary Trial ID Number
Summary
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.
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)
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Newcastle & North Tyneside 1 Research Ethics Committee. Original approval given 20th January 2011. Amendment No 1 (08/02/2011) approval given 21/02/2011
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
188
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 Exclusion Criteria
  • 1. Women with babies with major congenital anomalies
  • 2. Women who's 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
Interventions
OBBA, Education session with mothers to teach how to optimising baby to breast attachment.; Study Entry : Registration and One or More Randomisations
Design Details
Sorry, this information is not available
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)
Results Reporting
Sorry, this information is not available
Acronym
OBBA
Scientific Title
Optimising Baby to Breast Attachment (OBBA): a mixed method study
Secondary Trial Identifying Number
9863
Website
Sorry, this information is not available
Study Funded By
National Institute for Health Research (NIHR) (UK) - Doctor Research Fellowship
Funder Type
Sorry, this information is not available
Study Sponsored By
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Mar 2011

Recruitment End Date

01 Apr 2013

Trial End Date

01 Apr 2013

Date added to Registry

28 Mar 2011

Last Updated

29 Mar 2011