Breastfeeding initiation and continuation Pregnancy and Childbirth
Conditions
Interventions
The study design is a randomised controlled trial with women randomised to receive the additional ABA-feed
intervention or usual feeding support.
The researchers aim to recruit women, 2730 women aged
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Age
16 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant with their first child 2. Singleton pregnancy 3. Aged 16 years or over 4. Provided informed consent 5. Gestation age from 20+0 to 35+6 (inclusive) weeks gestation
Exclusion criteria
Exclusion criteria: 1. Women who have had a previous live birth 2. Non-English speaking pregnant women with no Infant Feeding Helper in their locality able to speak their language are not eligible to be randomised into the ABA-feed Trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/10/2024: Any breastfeeding at 8 weeks post birth, measured by self-report in the 8-week questionnaire (or subsequent text message for non-responders) with missing data supplemented from health visitor records _____ Previous primary outcome measure: Any breastfeeding at 8 weeks post birth, measured by self-report in the 8-week questionnaire (or subsequent text message for non-responders) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any breastfeeding measured using infant feeding status, self-reported formula feeding practices at 16 weeks post birth 2. Any breastfeeding measured using infant feeding status, self-reported formula feeding practices at 24 weeks post birth 3. Exclusive breastfeeding measured using infant feeding status, self-reported formula feeding practices at 16 weeks post birth 4. Exclusive breastfeeding measured using self-reported formula feeding practices at 24 weeks post birth 5. Time to cease exclusive feeding with breastmilk measured using infant feeding status, self-reported formula feeding practices up to 16 weeks 6. Time to cease feeding with any breastmilk measured using infant feeding status, self-reported formula feeding practices up to 16 weeks 7. Maternal anxiety measured using the Generalised Anxiety Disorder Assessment (GAD-7) at 8 weeks post birth 8. Maternal anxiety measured using the GAD-7 at 16-weeks post birth 9. Maternal health-related quality of life measured by the EuroQol (EQ-5D-5L) at 8 weeks 10. Maternal health-related quality of life measured by the EQ-5D-5L at 16 weeks 11. Maternal social support measured by Medical Outcomes Study (MOS) Emotional/Informational Support domain at 8-weeks post birth 12. Maternal social support measured by MOS Emotional/Informational Support domain at 16 weeks post birth 13. The following maternal formula feeding practices measured using infant feeding status, self-reported formula feeding practices at 8 and 16 weeks post birth: 13.1. Making one feed at a time 13.2. Correct water temperature 13.2. Adding formula powder before water 13.3. Making up formula when needed when out of the home 13.4. Keeping milk chilled when out of the home 13.5. Making formula with hot water when out of the home 13.6. Sterilising bottles using recommended methods 14. Maternal use of support for infant feeding (e.g. national breastfeeding helpline; peer support; breastfeeding groups) measured using infant feeding status, self-reported | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed