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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014