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

April 12, 2024 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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:

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
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: Experimental group
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
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)
Other Names:
  • The role of diet, products consumption, type of cooking, energy used and breastfeeding vs. artifitial lactancy in the carbon footprint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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)
Time Frame: months 30-36 of the project life
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: fase I) months 15-17 of the project life & phase 2) 30-36 of the project life
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
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
Time Frame: months 22-31 of the project life
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)
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)
Time Frame: months 30-36 of the project life
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.
months 30-36 of the project life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Fundació Institut Germans Trias i Pujol
University of Barcelona
Hospital de Granollers
Parc Taulí Hospital Universitari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22/101-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child, Only

Clinical Trials on The educational programme on sustainable and healthy diet and breastfeeding

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe