- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00635453
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cluster randomized controlled trial targeting selected primary health care centers in Porto Alegre, South of Brazil, a city of 1.4 million inhabitants. The trial included health centers that provide primary care services predominantly to low-income families.Physicians, nurses and administrative staff of all intervention health centers participated in a training in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.
Following staff training at the intervention sites, interviewers visited the intervention and control health centers from April to December 2008 to identify and enroll pregnant women who were in the last trimester of pregnancy. 98% of eligible pregnant women agreed to participate and answered a questionnaire about their socioeconomic status and expected due date. Addresses and telephone numbers were obtained in order to schedule subsequent home visits.
Data Collection:
Maternal interviews using structured questionnaires were conducted at baseline (during pregnancy - 2008) and at follow-up home-visits at mean child ages six months (2008/2009), 12 months (2009/2010) , three years (2011/2012) and six years (2014/2015) by field workers who were not involved in the intervention and who were unaware of the group allocations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil
- The health units
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All pregnant women in the last trimester of the gestation.
Exclusion Criteria:
- HIV-positive mothers
- congenital malformation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: I, Intervention
Physicians, 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.
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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.
Other Names:
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No Intervention: II, Control
Healthcare 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exclusive Breastfeeding at Four Months of Age
Time Frame: Six months after the beginning of the study
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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.
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Six months after the beginning of the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Overweight Children at 12 Months of Age
Time Frame: 12 months after the beginning of the study
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The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age
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12 months after the beginning of the study
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Number of Overweight Children at 3 Years of Age
Time Frame: 3 years after the beginning of the study
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The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age
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3 years after the beginning of the study
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Number of Overweight Children at 6 Years of Age
Time Frame: 6 years after the beginning of the study
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The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age
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6 years after the beginning of the study
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food Consumption
Time Frame: Six and twelve months, three and six years after the beginning of the study
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Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food)
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Six and twelve months, three and six years after the beginning of the study
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Márcia R Vitolo, Postdoctoral, Federal University of Health Sciences of Porto Alegre
Publications and helpful links
General Publications
- Sangalli 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.
- Ferreira 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.
- Chaffee 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.
- Chaffee 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- vitolo3
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