NCT05729581

Brief 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. Objectives: 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.7 years

First QC Date

January 27, 2023

Last Update Submit

April 12, 2024

Conditions

Keywords

lactation typebreastfeedingsustainable dietenvironmental impactcarbon footprintone health

Outcome Measures

Primary Outcomes (2)

  • 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)

    months 30-36 of the project life

  • 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).

    months 30-36 of the project life

Secondary Outcomes (3)

  • 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

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

  • 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

    months 22-31 of the project life

  • 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)

    months 30-36 of the project life

Study Arms (2)

Control group

NO INTERVENTION

This 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 group

EXPERIMENTAL

This group of pregnant women (24-32 SG) will be provided educational programme and information on sustainlably and healthy diet and sustainable breastfeeding

Behavioral: The educational programme on sustainable and healthy diet and breastfeeding

Interventions

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)

Also known as: The role of diet, products consumption, type of cooking, energy used and breastfeeding vs. artifitial lactancy in the carbon footprint
Experimental group

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASSIR Metropolitana Nord

Sabadell, Spain

RECRUITING

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Breast Feeding

Interventions

Diet, HealthyLactation

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

DietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Central Study Contacts

Gemma Falguera Puig, PhD

CONTACT

Liudmila Liutsko, PhD.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 15, 2023

Study Start

April 11, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations