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Clinical Trials/NCT00629629
NCT00629629
Completed
Not Applicable

Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

Federal University of Health Science of Porto Alegre1 site in 1 country500 target enrollmentOctober 2001

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia
Sponsor
Federal University of Health Science of Porto Alegre
Enrollment
500
Locations
1
Primary Endpoint
Effectiveness of a nutrition advice programme in exclusive breastfeeding.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
May 2015
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Marcia Regina Vitolo

PhD

Federal University of Health Science of Porto Alegre

Eligibility Criteria

Inclusion Criteria

  • Newborn infants with birth weight ≥ 2.500 g and gestational age ≥ 37 weeks were considered eligible for the study.

Exclusion Criteria

  • HIV-positive mothers
  • Congenital malformation
  • Infants referred to intensive care unit
  • Multiple pregnancy.

Outcomes

Primary Outcomes

Effectiveness of a nutrition advice programme in exclusive breastfeeding.

Time Frame: 1 year

Group difference in months of esclusive breastfeeding

Effectiveness of a nutrition advice programme in dietary intake

Time Frame: 12 years

Group differences in energy, fats, protein, carbohidrates and micronutrients intake

Secondary Outcomes

  • Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.(1 year)
  • Effectiveness of a nutrition advice programme in nutritional status(12 Years)
  • Salty taste preferences(12 years)

Study Sites (1)

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