Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
This study has been completed.
Sponsor:
Federal University of Health Science of Porto Alegre
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 June 18, 2013