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

Child, Only Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05729581
• Other study ID #: 22/101-P
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Gemma Falguera Puig, PhD
• Phone: +(34)936932732
• Email: gfalguera.mn.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Environmental-Pollution-Related Condition
• Health Behaviour
• Healthy Diet
• Mothers

Intervention

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)

Locations

Country	Name	City	State
Spain	ASSIR Metropolitana Nord	Sabadell

Sponsors (5)

Lead Sponsor	Collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	Fundació Institut Germans Trias i Pujol, Hospital de Granollers, Parc Taulí Hospital Universitari, University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	fase I) months 15-17 of the project life & phase 2) 30-36 of the project life
Secondary	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)	months 22-31 of the project life
Secondary	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.	months 30-36 of the project life