Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-4mkg73 |
Date of registration:
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07/03/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Lifestyle intervention in pregnant women.
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Scientific title:
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Impact of an intervention for promotion leisure-time walking and healthy eating among pregnant women in antenatal care. |
Date of first enrolment:
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01/11/2012 |
Target sample size:
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Recruitment status: |
Data analysis completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-4mkg73 |
Study type:
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Intervention |
Study design:
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Preventive, parallel, open, non-randomized controlled clinical trial with two arms.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maíra Barreto
Malta |
Address:
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Rua Egidio Martins
11030-160
Santos
Brazil |
Telephone:
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+55 (13) 98140 5009 |
Email:
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mairamaltanutri@gmail.com |
Affiliation:
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Faculdade de Saúde Pública USP |
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Name:
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Maíra Barreto
Malta |
Address:
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Rua Egidio Martins
11030-160
Santos
Brazil |
Telephone:
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+55 (13) 98140 5009 |
Email:
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mairamaltanutri@gmail.com |
Affiliation:
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Faculdade de Saúde Pública USP |
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Key inclusion & exclusion criteria
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Inclusion criteria: pregnant women enrolled in the antenatal low-risk public health system in the urban area of Botucatu-SP; aged equal to or greater than 18 years old; being in the first trimester.
Exclusion criteria: prenatal care in private health services; change city; Suffer abortion; Have high obstetric risk (pre-eclampsia,gestational diabetes).
Age minimum:
18Y
Age maximum:
Gender:
F
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Health Condition(s) or Problem(s) studied
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Pregnancy complications
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C13.703
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Intervention(s)
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N02.370
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F01.145.407.432
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F01.145.632
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Behavioural
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The intervention is divided into two main components: 1) Training all of doctors and nurses responsible for antenatal care in 9 family health units (n=22) through an educational activity, lasting 16 hours, consisting of an immersion course and three workshops. This training aimed to update, standardize and expand professionals’ knowledge of healthy eating and physical activity during pregnancy and help them promote these behaviors in antenatal care in a systematic manner. In addition, to support professionals’ promotion of these behaviors, the following educational materials were developed: a form with key information about food and walking to visually support the conversation between the professionals and pregnant women; a folder provided to pregnant women; posters containing messages encouraging the adoption of the promoted behavior; an assessment of gestational weight gain and record of the guidelines about food and walking provided to pregnant women, as noted on their antenatal card. The control group (n=20) was formed by doctors and nurses who worked in 8 basic health units of traditional model (UBS) in the same municipality and did not receive any intervention. 2) Systematic promotion of eating behaviors and physical activity during antenatal visits. The 181 pregnant women were counseled about the importance and benefits of five healthy eating habits and motivated to adopt these habits: intake of three fruits daily; two portions of vegetables (one raw and one cooked) and two portions of beans (one at lunch and one at dinner) at least five days per week; sporadic consumption of soft drinks and industrially processed cookies. These recommendations were based on national guidance about healthy eating during pregnancy, with priority given to the most inappropriate
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Primary Outcome(s)
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Increase in the percentage of pregnant women who reach the recommendation of 150 minutes a week of leisure-time walking in the third trimester, observed from an increase of 5% control group to 15% in intervention group.
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Secondary Outcome(s)
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Increase in the percentage of pregnant women consuming at least one fruit, five times a week or more in the intervention group compared to the control.
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Reduction of the percentage of pregnant women who consumed soda and / or processed biscuit twice a week or more in the intervention group compared to the control.
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Increase in the percentage of pregnant women who consume at least one raw vegetable and one cooked five times a week or more in the intervention group compared to the control.
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Increase in the percentage of pregnant women consuming beans at least twice a day, five times a week in the intervention group compared to the control.
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Source(s) of Monetary Support
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Fundação de Alparo à pesquisa do Estado de São Paulo - FAPESP
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Conselho Nacional de Desenvolvimento Científico e Tecnológico - CNPq
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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