Study design
This is a multicenter cluster randomized interventional study that will be conducted in the Barcelona Metropolitan North Area. The participating sites are the primary care centers for pregnancy and postpartum check-ups and hospitals—Hospital Parc Taulí, Hospital General de Granollers, Hospital Germans Trias i Pujol and Hospital de Mataró— that attend the same population. This study will have follow-up periods of participants from 24 weeks of gestation to 6 months postpartum.
It is an intervention study with two groups (by a random assignment of the participating centers): 1) EG (which receives an education intervention program providing support and extra resources on sustainable nutrition and breastfeeding and their environmental impacts and 2) CG (which receives standard care).
Sample size calculation
126 subjects in each of both arms groups are needed to detect a statistically significant difference between the two rates, accepting a 95% confidence level and 80% power in a two-tailed test. Based on data published in 2019 on the study population [15], the rate of EBF is expected to be 17% in the CG and 34% in the EG. The rate of loss to follow-up is estimated to be 20%. Finally, a total of 252 subjects will be studied, with 126 in both groups.
Participants, inclusion and exclusion criteria
The study population will consist of pregnant women from the previously mentioned primary care settings with deliveries planned in the hospitals participating in this study (mentioned above).
Regarding the inclusion criteria, subjects receiving care at the primary care centers and hospitals included in the study and who are at least 16 years of age and between 24 and 32 weeks of pregnancy and have intention for breastfeeding will be included in the study.
The exclusion criteria are language barriers preventing informed consent and consent withdrawal.
Procedure
Recruitment
Midwives from the participating centers will recruit pregnant women at 24-32 weeks of gestation (WG) who meet the inclusion criteria and agree to participate by signing the informed consent.
Intervention program
Training of the healthcare workers involved in the project, the educational intervention in the EG, and participant follow-up
The educational and support intervention is multimodal and has five dimensions (see also Table 1):
A) For health professionals (only for EG centers):
1. Creation of a care protocol for breastfeeding mothers to be used in both primary care centers and hospitals to achieve excellence in care for mothers and infants that will include environmental benefits/impacts of nutrition and feeding also: the “Guide to best practices on breastfeeding, nutrition and sustainability” based on the “Clinical Practice Guide to Breastfeeding”[1].
2. Training will be provided to health workers—professionals at ASSIRs, hospitals and pediatricians participating in the GREEN MOTHER project—at the primary care centers, focusing on breastfeeding, healthy diet and related environmental impacts, including carbon footprint, life cycle and sustainability. This information will be based on the results of Phase I. This information will be offered in hospitals as part of the current courses on breastfeeding, scheduled for the second trimester of 2023.
B) For pregnant and postpartum women (only from EG):
3. Equipping waiting rooms and other spaces and resources
Other specific resources to support the project will be provided at the primary attention centers and hospitals, from sofas for breastfeeding, to support and counselling from midwives to overcome any potential difficulties that may arise.
4. Educational materials (a) and special sessions (b) on sustainable feeding and nutrition will be developed by the GREEN MOTHER team and offered to pregnant women (from 24 weeks of gestation onwards) in the EG of the GREEN MOTHER project by previously trained health workers (dimension 2), which will differ from the standard courses provided in the CG.
Educational leaflets with information on how to achieve a sustainable diet and BF with healthy menus, shopping examples, etc., previously prepared, will be distributed to the participants. This informative material will also be displayed on the screens and wall posters in waiting rooms (with a QR code to access the digital leaflets). They will focus on specific citizen actions and key points of care during the project (at the center where the EG will be randomly assigned) and, once data collection is finalized, at all centers to promote a sustainable diet and breastfeeding.
5. Special care for women (EG) at the individual level in hospitals and primary care centers following the “Guide to best practices on breastfeeding, nutrition and sustainability” (developed during the project, see dimension 1) and offering support for behavioral skills that promote more sustainable nutrition and breastfeeding using the resources provided (see dimension 4).
Sustainability of the project products over time (after finishing the project)
Once the project is finalized, the protocol developed will be used to train all health workers involved in the care of mother and baby to place emphasis on the nursing mother, provide the best conditions for a good start to breastfeeding, and offer support for any difficulties that may arise. It will include information on how to follow a sustainable, environmentally friendly and healthy diet. A specific course will be offered at primary care centers for this project with the goal of it becoming a continuing education course later.
Variables
This study (Phase II) will use the same variables as Phase I (see Annex I): 1) general sociodemographic and clinical data will be collected from the participants; 2) type of feeding, amount of infant formula and accessories used; 3) habits related to eating, cooking and food purchases; and 4) a 24-hour register of the food items consumed by the mother will be logged via a questionnaire [22,23]. The data will be collected from questionnaires completed by the researcher in charge of participant recruitment, using the secure REDCap® [24] web application.
In addition, specifically to the current study (Phase II), we will collect extra variables related to the delivery and puerperal data (VAS [25] and LATCH [26] scales), as well variables to assess the educational and support intervention (see Annex II). The collection of data by time and place and instruments used are presented in the Table 2.
Table 1. The educational and support intervention program overview performed in EG centers
|
TIMEPOINT
|
Before recruitment
|
Pregnancy
|
Delivery
|
Postpartum visits
|
After the project
|
|
24 GW
|
28-32 GW
|
Birth
|
Immediate
|
Early
|
M1
|
M3
|
M4
|
M6
|
|
Place
|
Primary care
|
Hospital
|
Hospital
|
Primary care
|
|
N
|
|
Intervention type / for whom
|
|
|
For health professionals
|
|
1
|
Creation & use of “Guide to best practices on breastfeeding, nutrition and sustainability"
|
√
|
|
|
|
|
|
|
|
|
|
√**
|
2
|
Training of health workers
|
√
|
|
|
|
|
|
|
|
|
|
√
|
|
For pregnant and postpartum women
|
|
3
|
Equipping spaces and providing resources
|
√
|
|
|
|
|
|
|
|
|
|
√
|
4a
|
Educational leaflets
|
√
|
|
|
|
|
|
|
|
|
|
√
|
4b
|
The educational program:
Special sessions on sustainable feeding and nutrition will be offered to pregnant women: 1.- Breastfeeding 2.- Sustainable feeding 3.- Healthy nutrition (1 hour per session)*
|
|
|
√
|
|
|
|
|
|
|
|
√**
|
5
|
Individual special care for women in hospitals and primary care centers following the “Guide"
|
|
√
|
|
√
|
√
|
√
|
√
|
√
|
|
√
|
√
|
Legend: * versus standard educational courses and care in the CG; ** - can be used (and up-dated if needed with time).
Table 2. Data collection protocol of the GREEN MOTHER-II study
|
Place
|
Primary care
|
Hospital
|
Hospital
|
Primary care
|
Primary care
|
Phone Call
|
INSTRUMENTS
|
Validated instruments /Time
|
24 WP
|
Birth
|
Immediate puerperium
|
Postpartum
|
4-6 W
|
M3
|
M4
|
M6
|
Informed consent to be signed
|
|
√
|
|
|
|
|
|
|
|
Questionnaires ad-hoc REDCap:
|
|
|
|
|
|
|
|
|
|
1) General sociodemographic and clinical data
|
√
|
|
|
|
|
|
|
|
2) Newborn variables:
|
|
|
√
|
√
|
√
|
√
|
|
|
|
Breastfeeding observation
|
LATCH Scale
|
|
|
√
|
√
|
|
|
|
|
Obstetric pain
|
VAS Scale
|
|
|
√
|
√
|
|
|
|
|
Tongue tie
|
|
|
|
√
|
√
|
|
|
|
|
Nipple wounds
|
|
|
|
√
|
√
|
|
|
|
|
Other puerperium variables
|
|
|
√
|
√
|
√
|
|
|
|
|
3) Feeding accessories
|
|
|
|
|
√
|
|
|
|
4) Mother's nutrition variables:
|
|
|
|
|
|
|
|
|
|
Purchasing and cooking habits
|
|
|
|
|
|
√
|
|
|
|
Register of the mother's daily diet (24h)
|
“24-hour food register. 24hR”
|
|
|
|
|
√
|
|
|
|
5) Feeding type
|
|
|
√
|
|
|
√
|
√
|
√
|
√
|
EXPECTED OUTCOMES AND DATA ANALYSIS PLAN
Expected outcomes:
1. Differences in the rates of three feeding types between the mothers of the two study groups in the first 6 months of the baby’s life.
2. Differences in feeding accessories used and dietary habits with associated factors (in terms of sustainability) between mothers in the EG and CG at one month of the baby’s life.
Data analysis plan:
Relevant quantitative descriptive and statistical inference methods will be applied to determine statistical differences (significance level p <.05) and/or regression analyses will be performed for the outcomes (1 and 2) depending on the group (CG vs. EG) and other study variables. The rate of feeding types will be calculated as percentages of the total number of participants as reported in the questionnaires.
Patient and public involvement
Mothers involved in breastfeeding and parenting will collaborate with the research team to assess and validate the content of the informative leaflets and other resources of the proposed educational interventions. We will also consider their opinions for the discussion of the project’s results and further dissemination to communities and the general public.
Ethics and safety
We will follow the guidelines of the Declaration of Helsinki regarding the bioethical principles of clinical research. The research protocol has been approved by the Research Ethics Committee (CEI) of the Jordi Gol Institute of Primary Care Research (IDIAP), as well as those of the reference hospitals participating in the study: Hospital Parc Taulí, Hospital General de Granollers, Hospital Germans Trias i Pujol and Hospital de Mataró.
The data collected by questionnaires on REDCap will be encrypted. The variables needed to conduct the study have been obtained directly from the project participants through their previously signed consent, in accordance with the provisions of articles 6.1.a) and 9.2.a) of the GDPR.
The REDCap platform will be used to carry out the project. It is hosted on the institution's servers and its security measures are determined by the institution. The data is stored on the local web server where the institution has installed the software and is therefore only accessible on computers that have a trusted connection to it via VPN (Virtual Private Network) and secure credentials (certificates, RSA keys, or complex passwords). A system has been incorporated so that only the application service can send data to the back office through a firewall that only allows requests from the application's IP addresses. The web server has the X-Frame-Options HTTP header setting enabled with the value "same-origin" to prevent clickjacking attacks.
Compliance with the Patient Autonomy Law will be ensured and the data will be anonymous in compliance with EU regulation 2016/679. The ICS is the data controller and the current study data owner.
[1] GPC_560_Lactancia_Osteba_resum.pdf (guiasalud.es)