Proactive telephone support for breastfeeding women in disadvantaged areas provided by a postnatal ward feeding support team

ISRCTN	ISRCTN27207603
DOI	https://doi.org/10.1186/ISRCTN27207603
Secondary identifying numbers	2010PH001

Submission date: 29/06/2010
Registration date: 02/08/2010
Last edited: 19/09/2013

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

Study website

Contact information

Dr Pat Hoddinott
Scientific

Senior Clinical Research Fellow and GP
Health Services Research Unit
University of Aberdeen
3rd Floor, Health Sciences Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Phone	+44 (0)1224 558988
Email	p.hoddinott@abdn.ac.uk

Study information

Study design	Single centre pilot randomised controlled trial embedded within a mixed methods action research study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information sheet available at http://viis.abdn.ac.uk/hsru/Fest/
Scientific title	Proactive telephone support for breastfeeding women in disadvantaged areas provided by a postnatal ward feeding support team: A nested, pilot, randomised controlled trial
Study acronym	FEST (FEeding Support Team Study)
Study objectives	1. Is additional pro-active (health service initiated) telephone breastfeeding support offered to women living in disadvantaged areas after hospital discharge feasible and likely to be more effective than reactive telephone support at increasing the proportion of women who are breastfeeding exclusively at 6-8 weeks? 2. Is it feasible to have a dedicated feeding team, with skill mix, based on a postnatal ward to deliver feeding support to women on the ward and a telephone support service for up to 2 weeks to breastfeeding women after hospital discharge? 3. What are the opportunities and barriers to implementing the above two interventions?
Ethics approval(s)	North of Scotland Research Ethics Committee approved on the 23rd of April 2010 (ref: 10/S0801/22)
Health condition(s) or problem(s) studied	Breast feeding
Intervention	A multi-skilled feeding team will be set up to provide breastfeeding support on the postnatal ward and deliver a pilot RCT of pro-active/reactive telephone support after hospital discharge. All trial participants: Specialised feeding support team care on the postnatal ward including watching a breast feed. Ability for patients to telephone the feeding support team for up to 2 weeks after hospital discharge. Intervention arm: In addition, pro-active (feeding team initiated) daily telephone calls following hospital discharge for 1 week, with the option to continue for an extra week unless she chooses to withdraw from the study or stops breastfeeding before then. RCT embedded within a before (3 months) and during the feeding support team intervention (3 months) audit of any breastfeeding (initiation and at 6-8 weeks after birth) 1. Steering group to oversee the project 1.1. Steering group of lay and professional representatives to meet every 4 weeks (recorded). Reflective action cycles. PH to chair. 1.2. Identify pregnant women due to deliver during the feeding team intervention and send information leaflets when they are 32-36 weeks pregnant 1.3. Map existing care pathways and resources for breastfeeding in Grampian to optimise the fit between the new feeding team and existing care. 1.4. Develop a triage system to assess need and provide other non-telephone support when required 2. Feeding team member characteristics 2.1. Feeding team members should 2.1.1. have personally breastfed 2.1.2. be trained and up to date in breastfeeding management ideally to UNICEF level 2.2. The team composition to be decided through the action research process. It might include midwives, nursery nurses, maternity aids, peer supporters. 3. Feeding team roles 3.1. To identify women initiating breastfeeding and living in eligible postcodes (list drawn up by the research team) and gain informed consent to participate 3.2. To watch a complete breastfeed for all women prior to hospital discharge and provide breastfeeding support on the ward for all consenting women 3.3. Document feeding method at discharge. If breastfeeding and they consent to the RCT they will be randomised immediately after hospital discharge 3.4. Immediately after hospital discharge, the feeding support team will access a web based independent randomisation system set up by CHART, a registered clinical trials unit at the University of Aberdeen, and they will be informed whether the woman is in the intervention (proactive daily phone calls) or control (no further intervention women can phone the team) arm 3.5. All women randomised to the telephone support trial will be able to initiate phone calls to the feeding team for the first 2 weeks after hospital discharge 3.6. In the intervention arm, maximum support would be pro-active (feeding team initiated) daily telephone calls following hospital discharge for 1 week, with the option to continue for an extra week unless she chooses to withdraw from the study or stops breastfeeding before then 3.7. Triage to other care pathways if indicated, including a face to face assessment at a mutually convenient time and place e.g. assessment of positioning and attachment 3.8. Complete a telephone and patient contact time log 3.9. Attend steering group meetings
Intervention type	Other
Primary outcome measure	Any breastfeeding at 6-8 weeks after birth
Secondary outcome measures	1. Exclusive breastfeeding at 6-8 weeks after birth 2. Satisfaction with hospital care 3. Satisfaction with care after discharge home 4. Process evaluation - qualitative interview data 5. Health Economic evaluation All outcomes to be assessed at 6-8 weeks after birth using modifications of the tools used in the BIG trial (ISRCTN44857041; see http://www.controlled-trials.com/ISRCTN44857041)
Overall study start date	26/07/2010
Completion date	20/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	60
Key inclusion criteria	Women living in the three most disadvantaged postcode area quintiles of the Scottish Index of Multiple Deprivation, who initiate breastfeeding while on a postnatal ward and consent to participate.
Key exclusion criteria	1. Serious maternal medical or psychiatric problems 2. Serious infant health problems 3. Language problems that cannot be resolved through the use of language line
Date of first enrolment	26/07/2010
Date of final enrolment	20/12/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Senior Clinical Research Fellow and GP

Aberdeen
AB25 2ZD
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

c/o Dr E Rattray
Deputy Director
Research and Innovation
Aberdeen
AB24 3FX
Scotland
United Kingdom

Phone	+44 (0)1224 277774
Email	e.rattray@abdn.ac.uk
"ROR"	https://ror.org/016476m91

Funders

Funder type

Government

NHS Grampian (UK) - Chief Executive Letter (CEL) 36: Nutrition of women of childbearing age, pregnant women and children under five in disadvantaged areas (funding allocation 2008 - 2011) (ref: 2010PH001)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/04/2012		Yes	No
Results article	process evaluation results	25/04/2012		Yes	No