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Clinical Trials/NCT00635453
NCT00635453
Completed
Not Applicable

Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers

Federal University of Health Science of Porto Alegre1 site in 1 country715 target enrollmentMarch 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Feeding and Eating Disorders of Childhood
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
715
Locations
1
Primary Endpoint
Exclusive Breastfeeding at Four Months of Age
Status
Completed
Last Updated
4 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2008
End Date
July 2, 2015
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Federal University of Health Science of Porto Alegre
Responsible Party
Principal Investigator
Principal Investigator

Marcia Regina Vitolo

Professor

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • All pregnant women in the last trimester of the gestation.

Exclusion Criteria

  • HIV-positive mothers
  • congenital malformation

Outcomes

Primary Outcomes

Exclusive Breastfeeding at Four Months of Age

Time Frame: Six months after the beginning of the study

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.

Secondary Outcomes

  • Number of Overweight Children at 12 Months of Age(12 months after the beginning of the study)
  • Number of Overweight Children at 6 Years of Age(6 years after the beginning of the study)
  • Number of Overweight Children at 3 Years of Age(3 years after the beginning of the study)

Study Sites (1)

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