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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629629
First Posted: March 6, 2008
Last Update Posted: March 6, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Health Science of Porto Alegre
  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
Intervention Model: Parallel Assignment
Masking: Single (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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: March 5, 2008
First Posted: March 6, 2008
Last Update Posted: March 6, 2008
Last Verified: March 2008

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