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

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT00629629
First received: March 5, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under than two years - on nutritional status and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mother's 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.


Condition Intervention
Anemia
Behavioral: Dietary Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Effectiveness of a nutrition advice programme in exclusive breastfeeding. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia, hospitalization and nutritional status. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 500
Study Start Date: October 2001
Study Completion Date: June 2003
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I, Intervention Behavioral: Dietary Advice

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629629

Locations
Brazil
Household
São Leopoldo, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Márcia R Vitolo, Doctor Federal University of Health Sciences of Porto Alegre
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Márcia Regina Vitolo, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT00629629     History of Changes
Other Study ID Numbers: vitolo2
Study First Received: March 5, 2008
Last Updated: March 5, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Health Science of Porto Alegre:
Health Plan Implementation
Feeding and Eating Disorders of Childhood
Breastfeeding
Complementary feeding
Morbidity
Anemia
Public policy

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on April 22, 2014