ISRCTN - ISRCTN47056748: Successful breastfeeding promotion: a motivational instructional model applied and tested

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marlene Sinclair

ORCID ID

Contact details

Room 24L12
University of Ulster
Jordanstown
Belfast (Northern Ireland)
BT37 OQB
United Kingdom
+44 (0)28 90 368118
m.sinclair1@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAT/1863/01 (The Research and Development Office Northern Ireland)

Study information

Scientific title

Successful breastfeeding promotion: a motivational instructional model applied and tested

Acronym

Study hypothesis

Breastfeeding initiation rates have increased over the last decade; however, breastfeeding duration rates have not (Infant Feeding Survey 2002). One fifth of women reportedly stop breastfeeding before leaving hospital. This study tested a motivational intervention delivered through routine midwife instruction with the intention of increasing women's motivation to sustain breastfeeding while receiving instruction from midwives.

The null hypothesis tested that there was no difference in the motivational outcomes of women who received the motivationally-enhanced version of midwife instruction and those who received current midwife instruction in accordance with best practice.

Ethics approval

Received from University of Ulster Research Ethical Committee in October 2004, transferred to Office for Research Ethics Committees Northern Ireland (ORECNI) in May 2006 (ref: 03/97).

Study design

Intervention single-centred single-blind trial (women were blind to group, stickers indicated group to midwives). Prior to recruitment a randomised table was created

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Breastfeeding promotion

Intervention

Control group:
The control group received breastfeeding instruction in step with the Baby Friendly Initiative and according to National Institute for Clinical Excellence (NICE) guidelines.

Intervention group:
The intervention group received a motivationally-enhanced version of the same instruction which was called 'Designer Breastfeeding'. As a result both groups received a two-hour antenatal infant feeding class, a breastfeeding book and midwife support for the first three postnatal weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Using seven point Likert scales women's motivational profile was measured in relation to three motivational factors:
1. Total value placed on breastfeeding
2. Total perceived midwife support
3. Total expectancy for successful breastfeeding

The Breastfeeding Instructional Motivation Measurement Tool was developed specifically for this study. Using factor analysis (n = 199) the reliability coefficients for the three motivational factors were satisfactory (Cronbach Alpha .8622, .8751, .8549). Data were collected on discharge from hospital by structured interview.

Primary outcomes were measured on discharge from hospital.

Secondary outcome measures

1. Breastfeeding behaviour was measured as a secondary outcome on discharge from hospital and at 3 weeks postnatal
2. Breastfeeding initiation was defined according to the Department of Health as giving one breastfeed or one episode of expressed breastmilk
3. Duration of breastfeeding was categorised in accordance with the Index of Breastfeeding Status (cited by Harmon-Jones, 2006), which classified breastfeeding on a scale in accordance with the amount of breastmilk the infant is receiving (1 = 100% breastmilk, 2 = more than 80% breastmilk and less than 20% other, 3 = 50 - 80% breastmilk, 4 = 50% breastmilk, 5 = 20 - 50% breastmilk, 6 = less than 20% breastmilk, 7 = 100% artificial milk).

Secondary outcomes were measured on discharge from hospital, and were repeated at 3 weeks postnatal (in the community and just prior to transfer of care to the health visiting services).

Overall trial start date

01/12/2005

Overall trial end date

01/10/2006

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All consenting primgravida women (20 weeks gestation) who attended at the time of recruitment
2. Inclusion criteria included their intention to have their baby at the research hospital
3. No age limit was applied

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Assessed for eligibility (n = 234), excluded (n = 34), declined (n = 9), consented (n = 182), completed (n = 144)

Participant exclusion criteria

1. Incidents where a mother and baby were separated, for example when a baby was admitted to the neo-natal unit and did not receive routine instruction
2. Women who had already commenced the 'young mums' parentcraft program prior to 20 weeks gestation (19 years old or less)
3. Women who for ethical reasons were considered vulnerable, for example, women who neither spoke or understood English
4. Women who declined to participate

Recruitment start date

01/12/2005

Recruitment end date

01/10/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Room 24L12, University of Ulster
Belfast (Northern Ireland)
BT37 OQB
United Kingdom

Sponsor information

Organisation

University of Ulster (UK)

Sponsor details

Shore Road
Jordanstown
Belfast (Northern Ireland)
BT37 OQB
United Kingdom
+44 (0)8 700 400 700
online@ulster.ac.uk