AzTrials
AzTrials

Healthy DietNCT05729581

Effectiveness of Educational Intervention on Sustainable Breastfeeding: The GREEN MOTHER Project

A study testing The educational programme on sustainable and healthy diet and breastfeeding in people with Healthy Diet and Health Behaviour, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Breastfeeding is the healthiest form of nutrition for the baby and is recommended to use exclusive breastfeeding (EB) until 6 months. The environmental footprint of artificial lactation (AL) has been studied, but that of EB is unknown. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
What is being tested?
The educational programme on sustainable and healthy diet and breastfeeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
429 participants
Where
1 siteSpain
Study dates
11 Apr 2022to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • pregnant women over 16 years of age, between 24 and 32 weeks of gestation

Who cannot join

  • women with a language barrier, under 16 years of age and those who do not want to participate or who do not give birth in the study associated centers

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • ASSIR Metropolitana Nord

    Sabadell

Other trials in Spain

About this study

Official title: Effectiveness of a Reinforcement Intervention in the Breastfeeding Practice From Nutritional, Environmental and Postpartum Problem-solving Aspects to Increase the Prevalence of Breastfeeding at 6 Months Postpartum: The GREEN MOTHER Project

Breastfeeding is the healthiest form of nutrition for the baby and is recommended to use exclusive breastfeeding (EB) until 6 months. The environmental footprint of artificial lactation (AL) has been studied, but that of EB is unknown.

Objectives:

Read more

The main objective of the first phase of the study is to identify the environmental impact in terms of the carbon footprint of breastfeeding and artificial breastfeeding, taking into account the accessories necessary for breastfeeding and of the diet and the factors associated with the diet of postpartum women in first month of life of the babies.

The main objective of the second phase is to evaluate the impact of a standardized intervention of educational programme on sustainable breastfeeding, diet and environment protection, providing inputs obtained from the first phase on the carbon footprint in the first month of life of the child and the prevalence of breastfeeding at the first month of the baby's life.

Being tested
The educational programme on sustainable and healthy diet and breastfeeding
Keywords
lactation type, breastfeeding, sustainable diet, environmental impact, carbon footprint, one health
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The educational programme on sustainable and healthy diet and breastfeedingBehavioural

    Also called The role of diet, products consumption, type of cooking, energy used and breastfeeding vs. artifitial lactancy in the carbon footprint

    In the interventional group the educational programme of sustainable diet and breastfeeding will be provided before the delivery to see the impact on the prevalence of the breastfeeding at 1 and 6 months after delivery (compared with the group of control, without intervention)

Study groups in NCT05729581
Study groupRoleWhat they receive
Control groupNo interventionThis group of pregnant women (24-32 SG) will not be provided educational programme and information on sustainlably and healthy diet and sustainable breastfeeding. It is a control group.
Experimental groupExperimentalThis group of pregnant women (24-32 SG) will be provided educational programme and information on sustainlably and healthy diet and sustainable breastfeeding
Receives: Behavioral: The educational programme on sustainable and healthy diet and breastfeeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rates (number of participants, %) that use breastfeeding (exclusive) up to 6 months after the delivery

    The rate of breastfeeding (exclusive) will be observed up to 6 months after the participant's baby delivery and calucalted as a percentage or fraction compared to all participants: at month of the delivery (0 month) and 1, 3 and 6 months after the delivery (giving a birth)

    Measured: months 30-36 of the project life

  2. Rates (number of participants, %) that use EB (excusive breastfeeding) in EG (experimental group) vs. CG (group of control)

    Rates (number of participants, fractions or percentages) of breasfeeding will be calculated and compared in both groups: CG (control) vs. EG (experimental).

    Measured: months 30-36 of the project life

Secondary outcomes (3)

  1. To calculate the CO2 footprint and water consumption of different types of mother diet and lactation (breastfeeding and artificial one) based on data obtained from the questionnaires

    Calculation (with help of the external experts) of the environmental impacts on CO2 emissions (Climate change) and water consumption (Water scarcity), using the ISO 14040 and 14044, and other related ISOs impacts of a mother's daily diet and type of breastfeeding based on data obtained from questionnaires

    Measured: fase I) months 15-17 of the project life & phase 2) 30-36 of the project life

  2. Assess the nutritional quality of the diet of postpartum mothers at the month of their children's life based on data obtained from the questionnaires

    Assess the nutritional quality of the diet of postpartum mothers at the month of their newborn child's life: calculation of proportions of macro i micronutrients and comparison with standard recommendations (to see if the sustainable diet and breastfeeding is within healty standards or any supplementary of elements are required for it)

    Measured: months 22-31 of the project life

  3. Comparison of rates on breastfeeding vs. artificial lactation in the population of the Northern Metropolitan area: current study results (2022/2023 based on data obtained from the questionnaire) vs. 2017 (already published)

    Compare the results obtained for the rates on breastfeeding in the population of the Northern Metropolitana in the current study (2022/2023) with those obtained in 2017 (reported in the Lactem study) to see if any trends on dynamical changes in lactancy patterns are observed with time.

    Measured: months 30-36 of the project life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2023
  2. Study start11 Apr 2022
  3. Primary completion15 Oct 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Our study has 2 phases: 1) observational and 2) interventional (with educational programme): 1. st group - CG (control group) - mothers without intervention 2. nd group - EG (experimental group) - mothers with applied educational intervention on sustainable diet and breastfeeding
Masking
Single blind
Who is masked
Participant
Enrolment
429 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05729581
Sponsor's protocol ID
22/101-P
Status last verified
Nov 2025
First submitted
27 Jan 2023
Last updated
6 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cabedo-Ferreiro RM, Cos-Busquets J, Liutsko L, Reyes-Lacalle A, Garcia-Sierra R, Colldeforns-Vidal M, Vicente-Hernandez MM, Gomez-Masvidal M, Montero-Pons L, Lopez-Gimeno E, Cazorla-Ortiz G, Toran-Monserrat P, Falguera-Puig G. The role of midwives in advancing planetary health: Insights from the GREEN MOTHER project in Spain. Women Birth. 2026 Apr;39(2):102169. doi: 10.1016/j.wombi.2026.102169. Epub 2026 Feb 4.

    PubMed 41643357

  • Cabedo-Ferreiro RM, Liutsko L, Cos-Busquets J, Garcia-Sierra R, Colldeforns-Vidal M, Reyes-Lacalle A, Toran-Monserrat P, Vicente-Hernandez MM, Gomez-Masvidal M, Violan C, Montero-Pons L, Falguera-Puig G, Cazorla-Ortiz G. Effectiveness of an Educational and Counseling Program (the Green Mother Project Phase 2) to Enhance Breastfeeding and Improve Mothers' Diets From an Environmental Perspective: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 26;15:e80358. doi: 10.2196/80358.

    PubMed 41587088

  • Cos-Busquets J, Cabedo-Ferreiro RM, Liutsko L, Reyes-Lacalle A, Garcia-Sierra R, Colldeforns-Vidal M, Andrade EP, Vicente-Hernandez MM, Gomez-Masvidal M, Montero-Pons L, Toran-Monserrat P, Falguera-Puig G, Cazorla-Ortiz G; GREEN MOTHER Group. A Comprehensive Assessment of the Environmental Impact of Different Infant Feeding Types: The Observational Study GREEN MOTHER. J Adv Nurs. 2025 Dec;81(12):8230-8241. doi: 10.1111/jan.16473. Epub 2024 Oct 3.

    PubMed 39362795

  • Cabedo-Ferreiro RM, Liutsko L, Cos-Busquets J, Garcia-Sierra R, Colldeforns-Vidal M, Reyes-Lacalle A, Vicente-Hernandez MM, Gomez-Masvidal M, Montero-Pons L, Cazorla-Ortiz G, Toran-Monserrat P, Violan C, Falguera-Puig G; GREEN MOTHER Group. Environmental impact of infant feeding type, accessories used and maternal dietary habits: The GREEN MOTHER-I project, a cross-sectional study protocol. Nutr J. 2024 Aug 21;23(1):97. doi: 10.1186/s12937-024-01000-9.

    PubMed 39164727

Questions about this trial

What is this clinical trial studying?

A study testing The educational programme on sustainable and healthy diet and breastfeeding in people with Healthy Diet and Health Behaviour, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates (number of participants, %) that use breastfeeding (exclusive) up to 6 months after the delivery (time frame: months 30-36 of the project life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05729581, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in