Early interventions to increase breastfeeding and reduce the use of infant formula
| ISRCTN | ISRCTN25035094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25035094 |
| Sponsor | Uppsala University |
| Funder | Uppsala Universitet |
- Submission date
- 04/06/2026
- Registration date
- 28/10/2026
- Last edited
- 28/10/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Breastfeeding provides important health benefits for both mothers and babies and is considered a key public health issue. Despite this, many mothers stop breastfeeding earlier than they would like. A common reason is that they do not receive enough information or support during the first days after birth. In Sweden, breastfeeding rates have also dropped significantly over the past twenty years.
As part of a larger study, the aims here are to find out whether a targeted breastfeeding support program for healthcare professionals—offered to parents before birth and during the first days afterwards—can help improve breastfeeding initiation, exclusivity, and duration, as well as decrease the use of infant formula. Furthermore, another goal is to evaluate the quality of care provided to newborns and their mothers. In addition, the study will explore parents’ experiences of breastfeeding and early parenthood, as well as their knowledge about the safe preparation and use of infant formula when needed.
The program is based on the World Health Organization’s “Ten Steps to Successful Breastfeeding", known in Sweden as the Baby-Friendly Hospital Initiative. It includes support for parents, training for healthcare staff, and improvements in care routines. WHO and UNICEF emphasize that these ten steps are important in all countries, regardless of income level, and previous research shows that interventions based on the ten steps can be effective.
Overall, the aim of the breastfeeding support program is to provide evidence-based, responsive support that helps new parents feel confident in breastfeeding and, when necessary, in safely using infant formula. By strengthening early support, the project hopes to give families a better start and improve the care of newborns and their mothers.
Who can participate?
Expectant and new parents and their infants.
What does the study involve?
It involves an intervention in the care continuum. For healthcare staff across the care continuum, the intervention includes a training package consisting of web-based courses, as well as a process‑oriented training day focused on improving care practices and routines, as well as safe formula feeding when there is a need to use it. For expectant and new parents, support will be provided through evidence‑based information brochures and educational materials designed to complement the verbal guidance offered by healthcare staff.
What are the possible benefits and risks of participating?
Breastfeeding is a key factor in achieving global goals related to nutrition, health, child survival, economic development, and environmental sustainability. Breastfeeding protects infants against infectious diseases such as diarrhoea, respiratory infections, and otitis media, as well as against diabetes, overweight, leukemia, necrotizing enterocolitis, and sudden infant death syndrome. Breastfeeding also supports cognitive development and is associated with higher IQ in children. For women, breastfeeding provides protective effects against breast cancer, ovarian cancer, and diabetes. Many women are not fully informed about the health benefits for themselves and their child, and many decisions regarding breastfeeding are made without the opportunity for informed choice. The right of study participants—and of all parents—to receive up‑to‑date, evidence‑based care, which this research project aims to support, outweighs the potential risk of misunderstandings that may arise in interactions between participants and researchers. The project is designed to strengthen informed decision‑making and ensure that parents have access to accurate, evidence‑based information about breastfeeding and safe infant feeding.
The study has received approval from the Ethical Review Board in Sweden. Parents will be informed about the study and that the participation is voluntary and confidential. Data will be securely stored according to data protection regulations.
Where is the study running from?
The study is coordinated by Uppsala University and conducted at a clinical site within the Gävleborg Region in Sweden.
When is the study starting and how long is it expected to run for?
October 2026 to March 2029
Who is funding the study?
The study is supported by the Centre for Research and Development, Uppsala University, Region Gävleborg, Gävle, Sweden.
Who is the main contact?
Eva-Lotta Funkquist, eva-lotta.funkquist@uu.se
Contact information
Principal investigator
Uppsala Universitet, Dag Hammarskjöldsväg 14B
Uppsala
75104
Sweden
| Phone | +46 (0)184710000 |
|---|---|
| arja.harila@uu.se |
Scientific
Uppsala Universitet, Dag Hammarskjöldsväg 14B
Uppsala
75104
Sweden
| Phone | +46 (0)730306201 |
|---|---|
| eva-lotta.funkquist@uu.se |
Public
Uppsala Universitet, Dag Hammarskjöldsväg 14B
Hudiksvall
75104
Sweden
| Phone | +46 (0)708957921 |
|---|---|
| erika.andresen@uu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | First, a control group of parent-infant pairs is recruited. Then, a planned educational intervention for healthcare proffessionals in the healthcare continuum is carried out. After the intervention is completed, additional parent-infant pairs are recruited to form the intervention group. |
| Purpose | Supportive care |
| Scientific title | Evaluation of an educational intervention to increase breastfeeding, reduce infant formula use, and enhance care practices |
| Study objectives | An intervention based on the 'Ten Steps to Successful Breastfeeding' will improve breastfeeding outcomes and care pracitces, and reduce the use of infant formula |
| Ethics approval(s) |
Approved 10/08/2020, Swedish Ethics Review Authority (Box 2110, Uppsala, 75002, Sweden; +46 (0)10-475 08 00; etikprovningsmyndigheten.se), ref: Dnr 2020-01417 |
| Health condition(s) or problem(s) studied | Breastfeeding among healthy term infants and their parents |
| Intervention | For healthcare staff across the care continuum, the intervention includes a training package consisting of web-based courses, as well as a process‑oriented training day focused on improving care practices and routines, as well as safe formula feeding when there is a need to use it. For expectant and new parents, support will be provided through evidence‑based information brochures and educational materials designed to complement the verbal guidance offered by healthcare staff. First, data is collected from the control group (parent-infant pairs) in the baseline measurement over an expected 6-month period; then, data collection is paused for an expected 4 months, and the intervention is implemented in the health care continuum. Then, data is collected from the intervention group (new parent-infant pairs) over an expected 6-month period. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/03/2029 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | All |
| Lower age limit | 0 Days |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | 1. Healthy full-term newborns 2. Mother must want to breastfeed and be fluent in the Swedish language |
| Key exclusion criteria | 1. Exclusion criteria for the infant are growth retardation, malformation or illness that prevents the possibility of breastfeeding, and need for care in the neonatal unit. 2. Exclusion criteria for the mother are serious mental illness or any known illness that negatively affects breastfeeding or requires supplemental feeding with infant formula for the child. |
| Date of first enrolment | 01/10/2026 |
| Date of final enrolment | 30/03/2028 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
04/06/2026: Study's existence confirmed by the Swedish Ethics Review Authority.
