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

This study has been completed.

Sponsors and Collaborators:	Federal University of Health Science of Porto Alegre National Counsel of Technological and Scientific Development, Brazil
Information provided by:	Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:	NCT00629629

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

MedlinePlus related topics: Anemia Breast Feeding

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study
Official Title:	Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

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, Rio Grande do Sul
Household
São Leopoldo, Rio Grande do Sul, Brazil

Sponsors and Collaborators

Federal University of Health Science of Porto Alegre

National Counsel of Technological and Scientific Development, Brazil

Investigators

Principal Investigator:

Márcia R Vitolo, Doctor

Federal University of Health Sciences of Porto Alegre

More Information

Publications of Results:

Vitolo MR, Bortolini GA, Feldens CA, Drachler Mde L. [Impacts of the 10 Steps to Healthy Feeding in Infants: a randomized field trial] Cad Saude Publica. 2005 Sep-Oct;21(5):1448-57. Epub 2005 Sep 12. Portuguese.

Feldens CA, Vítolo MR, Drachler Mde L. A randomized trial of the effectiveness of home visits in preventing early childhood caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):215-23.

Responsible Party:	Federal University of Health Science of Porto Alegre ( Márcia Regina Vitolo )
Study ID Numbers:	vitolo2
Study First Received:	March 5, 2008
Last Updated:	March 5, 2008
ClinicalTrials.gov Identifier:	NCT00629629
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

Study placed in the following topic categories:

Hematologic Diseases
Anemia
Healthy
Feeding and Eating Disorders of Childhood
Eating Disorders

ClinicalTrials.gov processed this record on January 16, 2009