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

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ClinicalTrials.gov Identifier: NCT00629629
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 6, 2008
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of Health Science of Porto Alegre

Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Behavioral: Dietary Advice Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
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
Study Start Date : October 2001
Actual Primary Completion Date : October 2002
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arm Intervention/treatment
I, Intervention Behavioral: Dietary Advice



Primary Outcome Measures :
  1. Effectiveness of a nutrition advice programme in exclusive breastfeeding. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]


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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.

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

Publications of Results:
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 Posted: March 6, 2008    Key Record Dates
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