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Clinical Trials/NCT05729581
NCT05729581Active, not recruitingNot Applicable

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

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina1 site in 1 country429 target enrollmentStarted: April 11, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
429
Locations
1
Primary Endpoint
Rates (number of participants, %) that use EB (excusive breastfeeding) in EG (experimental group) vs. CG (group of control)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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

Intervention: The educational programme on sustainable and healthy diet and breastfeeding (Behavioral)

Outcomes

Primary Outcomes

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).

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)

Secondary Outcomes

  • 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)

Investigators

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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