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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729581
Other study ID # 22/101-P
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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