LatchOn: a breastfeeding support study
| ISRCTN | ISRCTN14819650 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14819650 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/12/2018
- Registration date
- 11/02/2019
- Last edited
- 03/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Breastfeeding provides the best start for babies and is linked with many health benefits for both mother and baby. However, Ireland has one of the lowest rates of breastfeeding worldwide. In particular, women with a high bodyweight are less likely to start breastfeeding and breastfeed for a shorter amount of time. There are many complex reasons for this, but the research suggests that women would be more likely to breastfeed if breastfeeding was considered the normal way to feed a baby, and if she had good social and family support. In 2016, an intervention was tested to improve breastfeeding by providing special support from a lactation consultant before and after a mother had her baby. A support partner was invited to attend classes and provided her with a dedicated phone line to contact the lactation consultant if she had any problems. The intervention was carried out in the National Maternity Hospital, Dublin and Wexford General Hospital and it was very successful in improving rates of breastfeeding and self-confidence, but it needs to be tested out using good scientific methods, and to also see if this intervention would improve breastfeeding rates among women with high bodyweights, as these women and their children will potentially benefit the most from improved support. For this reason only women with body mass index (BMI) over 25 are included in this new study. This study aims to increase breastfeeding rates at 3 months, improve attitudes toward breastfeeding, increase breastfeeding self-confidence and support women in thinking breastfeeding is the normal way to feed her baby. The study also aims to find out which parts of the intervention are most effective in promoting breastfeeding.
Who can participate?
Women aged 18 and over who are pregnant for the first time (single pregnancy) with BMI 25 and over
What does the study involve?
Women are randomly allocated to either receive the breastfeeding support intervention as described above or to receive normal breastfeeding care at the hospital they are attending. Feeding methods are assessed using questionnaires completed by the mother at 3 months after birth.
What are the possible benefits and risks of participating?
It is predicted that those in the intervention will receive better breastfeeding support than currently provided in each hospital, and will therefore be more likely to start breastfeeding and to breastfeed for a longer time, compared to the women in the normal care group. It is not thought that there will be any risks linked to taking part in the intervention, or any benefits or risks for women in the normal care group.
Where is the study run from?
Four hospitals within the Ireland East Hospital Group (National Maternity Hospital, Dublin, Wexford General Hospital, St Luke’s Hospital Kilkenny, and Regional Hospital Mullingar)
When is the study starting and how long is it expected to run for?
August 2018 to November 2023
Who is funding the study?
Nursing and Midwifery Planning and Development Unit (Ireland)
Who is the main contact?
Prof. Fionnuala McAuliffe
Contact information
Scientific
UCD Perinatal Research Centre
National Maternity Hospital
65-66 Lower Mount Street
Dublin 2
D02 YH21
Ireland
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | LatchOn: a protocol for a multi-centre, randomised controlled trial of perinatal support to improve breastfeeding outcomes in women with overweight and obesity |
| Study acronym | LatchOn |
| Study hypothesis | The trialists hypothesise that the women in the intervention group will have higher rates of breastfeeding initiation, longer breastfeeding duration and higher breastfeeding self-efficacy than those in the control. They anticipate that the inclusion of the support partner will improve support-structure for the women in her home setting. |
| Ethics approval(s) | Current ethics approval as of 03/09/2021: Approved 18/12/2018, Amendment 1 (COVID-19 amendment to recruitment) approved 01/10/2020, Amendment 2 (extension to timeline for recruitment due to COVID-19) approved, National Maternity Hospital Ethics Committee (Holles Street, Dublin 2, Ireland; +353 6373588; ethicsresearch@nmh.ie), ref: EC.24.2018 Previous ethics approval: National Maternity Hospital Ethics Committee, 18/12/2018, ref: EC.24.2018 Dr John Murphy, Ethics Research Committee, National Maternity Hospital, Holles Street, Dublin 2, Ireland. Tel: 6373588. Email: ethicsresearch@nmh.ie |
| Condition | Breastfeeding |
| Intervention | Current interventions as of 03/09/2021: Randomisation will be 1:1 allocation. The randomisation will be performed stratified by Overweight: Obese in a 2:1 ratio (e.g. 20 Overweight for every 10 Obese). Randomisation will be also stratified by site, in a 4:1:1:2 ratio for Dublin: Kilkenny: Mullingar: Wexford. Given the nature of the intervention, neither the participants nor the researchers will be blinded to allocation. Intervention arm: This multi-component intervention targets both prospective mothers and their support partners and spans the perinatal period from late pregnancy to six weeks postpartum. Intervention components include group antenatal education for prospective mothers and their support partners, individual education for new mothers in the immediate postnatal period, and professional support for new mothers to six weeks postpartum. A version of the antenatal class the trialists propose to deliver as part of this study has been used in the feasibility study conducted at The National Maternity Hospital. However, the trialists will revise this class based on feedback from participants in the feasibility study and specific midwives trained to deliver the class. For example, based on the feasibility study the midwives suggested to provide a separate postnatal intervention class on a Friday afternoon-evening and the antenatal class will be held on Friday evening to enable support partners to attend. Through collaborating midwives at each study site, the trialists will identify volunteer breastfeeding mothers from the areas local to each study site to attend the antenatal class with her infant. This volunteer mother will be available to study participants after the class to answer any questions they may have about practical aspects of breastfeeding. If possible, the volunteer mother will also provide a live demonstration, breastfeeding her own baby in the class. Providing a live breastfeeding demonstration is an original approach that, to our knowledge, has not been previously reported in a breastfeeding intervention study. Attitudes toward breastfeeding will be targeted by providing education to mothers and their support partners, and by exposure to a breastfeeding mother. Subjective norms around infant feeding will be targeted by providing education to the pregnant woman’s support partner, by exposure to a breastfeeding mother, and by provision of breastfeeding support groups postpartum which will be attended by other breastfeeding mothers, normalising the behaviour. The mother’s perceived behavioural control of her ability to feed her baby (breastfeeding self-efficacy) will be targeted by providing antenatal and postnatal education that is realistic and describes what to expect when breastfeeding, including potential challenges that may arise and how to manage these challenges. This education will equip women with the skills and confidence to manage breastfeeding, increasing their self-efficacy. Education will be reinforced by weekly phone calls in the postpartum period from an International Board Certified Lactation Consultant (IBCLC) to answer any questions. Control arm: Women assigned to the control group will be provided with written information on antenatal and postnatal support for breastfeeding that is available in the study site hospital and community, and will receive routine antenatal care. Previous interventions: Randomisation will be 1:1 allocation and stratified by study site. Given the nature of the intervention, neither the participants nor the researchers will be blinded to allocation. Intervention arm: This multi-component intervention targets both prospective mothers and their support partners and spans the perinatal period from late pregnancy to six weeks postpartum. Intervention components include group antenatal education for prospective mothers and their support partners, individual education for new mothers in the immediate postnatal period, and professional support for new mothers to six weeks postpartum. A version of the antenatal class the trialists propose to deliver as part of this study has been used in the feasibility study conducted at The National Maternity Hospital. However, the trialists will revise this class based on feedback from participants in the feasibility study and specific midwives trained to deliver the class. For example, based on the feasibility study the midwives suggested to provide a separate postnatal intervention class on a Friday afternoon-evening and the antenatal class will be help on Friday evening to enable support partners to attend. Through collaborating midwives at each study site, the trialists will identify volunteer breastfeeding mothers from the areas local to each study site to attend the antenatal class with her infant. This volunteer mother will be available to study participants after the class to answer any questions they may have about practical aspects of breastfeeding. If possible, the volunteer mother will also provide a live demonstration, breastfeeding her own baby in the class. Providing a live breastfeeding demonstration is an original approach that, to our knowledge, has not been previously reported in a breastfeeding intervention study. Attitudes toward breastfeeding will be targeted by providing education to mothers and their support partners, and by exposure to a breastfeeding mother. Subjective norms around infant feeding will be targeted by providing education to the pregnant woman’s support partner, by exposure to a breastfeeding mother, and by provision of breastfeeding support groups postpartum which will be attended by other breastfeeding mothers, normalising the behaviour. The mother’s perceived behavioural control of her ability to feed her baby (breastfeeding self-efficacy) will be targeted by providing antenatal and postnatal education that is realistic and describes what to expect when breastfeeding, including potential challenges that may arise and how to manage these challenges. This education will equip women with the skills and confidence to manage breastfeeding, increasing their self-efficacy. Education will be reinforced by weekly phone calls in the postpartum period from an International Board Certified Lactation Consultant (IBCLC) to answer any questions. Control arm: Women assigned to the control group will be provided with written information on antenatal and postnatal support for breastfeeding that is available in the study site hospital and community, and will receive routine antenatal care. |
| Intervention type | Behavioural |
| Primary outcome measure | Feeding method assessed using self-reported questionnaires completed by the mother, Questionnaire on Infant Feeding (O’Sullivan et al., 2017) at 3 months postpartum |
| Secondary outcome measures | 1. Intention to breastfeed following the antenatal component of the intervention, assessed by open ended and closed ended questions in a questionnaire completed by the mother at pre-antenatal class 2. Initiation rates of breastfeeding, collected using hospital discharge data at discharge from hospital 3. Exclusive and any breastfeeding prevalence. assessed using a questionnaire completed by the mother, Questionnaire on Infant Feeding (O’Sullivan et al., 2017), at hospital discharge, 6 weeks and 6 months postpartum 4. Maternal and support partner attitudes toward breastfeeding, assessed by open ended and closed ended questions in a questionnaire completed by the mother at pre-antenatal class, 6 weeks, 3 months, and 6 months postpartum 5. Breastfeeding self-efficacy, assessed using Breastfeeding Self-Efficacy Short Form (Dennis, 2003) at pre-antenatal class, 6 weeks, 3 months, and 6 months postpartum |
| Overall study start date | 01/08/2018 |
| Overall study end date | 01/11/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 220 |
| Participant inclusion criteria | 1. Primiparous women 2. Singleton pregnancy 3. BMI ≥25 kg/m2 at booking visit 4. 26 – 34 weeks’ gestation at recruitment 5. Aged ≥18 years 6. Good understanding of English 7. Ability to give informed consent 8. Have a support partner available and willing to participate in the trial if they are randomised to the intervention group. This support partner may be the infant’s father, the pregnant woman’s male or female partner, the pregnant woman’s mother or sister or a friend. |
| Participant exclusion criteria | 1. Preterm (<37 weeks’ gestation) delivery 2. Any condition requiring medication that is contraindicated for breastfeeding |
| Recruitment start date | 01/05/2019 |
| Recruitment end date | 01/11/2022 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Dublin
D02 YH21
Ireland
Wexford
Y35 Y17D
Ireland
Kilkenny
Kilkenny
R95 FY71
Ireland
Co Westmeath
N91 NA43
Ireland
Sponsor information
University/education
Belfield
Dublin 4
D04 N2E5
Ireland
| Website | www.ucd.ie |
|---|---|
"ROR" |
https://ror.org/05m7pjf47 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists plan to publish a study protocol with a plan for data analysis, but this is not available yet. Study results will be published in peer-reviewed journals and presented orally and/or in poster format at conferences. The trialists may also create a policy brief aimed at government policymakers and others who are interested in formulating or influencing policy. It may take the form of a concise summary of breastfeeding issues in Ireland, the policy options to deal with it, and some recommendations on the best options as observed from the RCT. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Fionnuala McAuliffe. Data collected will be of quantitative nature, and will only be available post-completion of the trial. Consent will be obtained from participants to allow anonymous data sharing. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 08/04/2021 | 03/09/2021 | Yes | No |
Editorial Notes
03/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/05/2020 to 01/11/2022.
2. The overall trial end date has been changed from 01/12/2020 to 01/11/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/01/2021 to 01/12/2023.
4. The ethics approval has been updated.
5. The interventions have been updated.
6. Publication reference added.
7. The plain English summary has been updated to reflect the changes above.
13/02/2019: The recruitment dates were updated from 01/02/2019 - 01/02/2020 to 01/05/2019 - 01/05/2020.
