Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
1 other identifier
interventional
715
1 country
1
Brief Summary
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2015
CompletedResults Posted
Study results publicly available
February 22, 2019
CompletedAugust 20, 2021
August 1, 2021
2 years
March 5, 2008
October 9, 2018
August 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exclusive Breastfeeding at Four Months of Age
Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth.
Six months after the beginning of the study
Secondary Outcomes (3)
Number of Overweight Children at 12 Months of Age
12 months after the beginning of the study
Number of Overweight Children at 3 Years of Age
3 years after the beginning of the study
Number of Overweight Children at 6 Years of Age
6 years after the beginning of the study
Other Outcomes (1)
Food Consumption
Six and twelve months, three and six years after the beginning of the study
Study Arms (2)
I, Intervention
EXPERIMENTALPhysicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.
II, Control
NO INTERVENTIONHealthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.
Interventions
The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.
Eligibility Criteria
You may qualify if:
- All pregnant women in the last trimester of the gestation.
You may not qualify if:
- HIV-positive mothers
- congenital malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The health units
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (5)
Valmorbida JL, Baratto PS, Leffa PS, Sangalli CN, Silva JA, Vitolo MR. Consumption of ultraprocessed food is associated with higher blood pressure among 6-year-old children from southern Brazil. Nutr Res. 2023 Aug;116:60-68. doi: 10.1016/j.nutres.2023.05.012. Epub 2023 May 27.
PMID: 37354762DERIVEDSangalli CN, Leffa PS, Valmorbida JL, Lumey LH, Vitolo MR. Impact of promoting healthy infant feeding practices on energy intake and anthropometric measures of children up to 6 years of age: A randomised controlled trial. J Hum Nutr Diet. 2021 Oct;34(5):771-783. doi: 10.1111/jhn.12881. Epub 2021 May 25.
PMID: 34034359DERIVEDFerreira VR, Sangalli CN, Leffa PS, Rauber F, Vitolo MR. The impact of a primary health care intervention on infant feeding practices: a cluster randomised controlled trial in Brazil. J Hum Nutr Diet. 2019 Feb;32(1):21-30. doi: 10.1111/jhn.12595. Epub 2018 Sep 4.
PMID: 30182376DERIVEDChaffee BW, Vitolo MR, Feldens CA. The Porto Alegre Early Life Nutrition and Health Study. Rev Bras Epidemiol. 2014 Dec;17(4):1015-8. doi: 10.1590/1809-4503201400040018.
PMID: 25388499DERIVEDChaffee BW, Feldens CA, Vitolo MR. Cluster-randomized trial of infant nutrition training for caries prevention. J Dent Res. 2013 Jul;92(7 Suppl):29S-36S. doi: 10.1177/0022034513484331. Epub 2013 May 20.
PMID: 23690364DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marcia Vitolo
- Organization
- Universidade Federal de Ciências da Saúde de Porto Alegre
Study Officials
- PRINCIPAL INVESTIGATOR
Márcia R Vitolo, Postdoctoral
Federal University of Health Sciences of Porto Alegre
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
March 1, 2008
Primary Completion
February 28, 2010
Study Completion
July 2, 2015
Last Updated
August 20, 2021
Results First Posted
February 22, 2019
Record last verified: 2021-08