Evidence map›Paper›PMID 31910819›Full record

ArticleBMC pregnancy and childbirth2020

Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial.

Daniela Saes Sartorelli, Lívia Castro Crivellenti, Marina Garcia Manochio-Pina, Naiara Franco Baroni, Mariana Rinaldi Carvalho, Rosa Wanda Diez-Garcia, Laércio Joel Franco

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pregnancy and childbirth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Daniela Saes SartorelliDepartment of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil. daniss@fmrp.usp.br.ORCID http://orcid.org/0000-0003-2028-3274
Lívia Castro CrivellentiGraduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.
Marina Garcia Manochio-PinaProgram in Health Promotion, University of Franca, Avenida Dr. Armando Salles Oliveira, 201, Franca, SP, 14404-600, Brazil.
Naiara Franco BaroniGraduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.
Mariana Rinaldi CarvalhoGraduate Program of Public Health, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.
Rosa Wanda Diez-GarciaDepartment of Health Sciences, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.
Laércio Joel FrancoDepartment of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Brazil, Avenida Bandeirantes, 3900, Ribeirão Preto, SP, 14049-900, Brazil.
Universidade de São Paulo · BRUniversidade de Franca · BRUniversidade de Ribeirão Preto · BR

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 302487/2018- 2Conselho Nacional de Desenvolvimento Científico e Tecnológico 406000/2018-2Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/15386-2Fundação de Amparo à Pesquisa do Estado de São Paulo 2017/18980-2Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo 1039/2018Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo 1114/2018Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo 61/2019Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo 62/2019
6 · The paper itself

Abstract

backgroundEvidence from observational studies suggests that a greater intake of ultra-processed foods during pregnancy is associated with a higher chance of obesity, increased gestational weight gain, and neonatal adiposity. The aim of the present study is to evaluate the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women. Additionally, the effect of the intervention on pregnancy outcomes, neonatal adiposity, and the child's weight and height will be investigated.

methodsThis is a two-armed parallel randomized controlled trial that will be conducted at primary health units in Ribeirão Preto, SP, Brazil. Adult pregnant women who are overweight and receiving prenatal care in the public health system will be included. The women will be randomly allocated into control (standard care) or intervention groups. Those enrolled in the intervention group will participate in three individualized nutritional counselling sessions based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities. The recruitment of the participants will be carried out at seven health facilities over 12 months, with a sample of 300 women expected. Maternal anthropometric, sociodemographic, blood pressure, biochemical, and lifestyle data will be obtained at baseline (up to the 16th week of gestation), and during a second assessment (34th to 36th gestational week). The neonate body composition will be estimated after birth, and data on pregnancy outcomes, weight and height of children at 6, 12 and 24 months of age will be further obtained from medical records. DISCUSSION: This will be the first randomized controlled trial to test the effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in adult, overweight, pregnant women. Furthermore, the effect of the intervention on pregnancy outcomes, neonatal adiposity and the child's weight and height will be evaluated.

trial registrationRegistro Brasileiro de Ensaios Clínicos (Rebec) RBR-2w9bhc July 30th 2018 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-2w9bhc+), and RBR-7yx36h June 4th 2019 (http://www.ensaiosclinicos.gov.br/rg/?q=RBR-7yx36h+0.

Indexed as

AdultBrazilChild, PreschoolDiet, HealthyExerciseFemaleFood HandlingGestational Weight GainHumansInfantInfant, NewbornMaternal Nutritional Physiological PhenomenaOverweightPregnancyPregnancy ComplicationsPregnancy OutcomeAdiposityFood processingGestational weight gainLifestyle interventionNewbornNOVA classificationOverweightPregnancyProtocolRandomized clinical trial

Identifiers

PMID31910819
PMCPMC6947817
OpenAlexW3002798595

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.