Anemia Clinical Trial
Official title:
Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
NCT number | NCT00629629 |
Other study ID # | vitolo2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2001 |
Est. completion date | May 2015 |
Verified date | October 2022 |
Source | Federal University of Health Science of Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers 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, 4 years, 8 years and 12 years of age.
Status | Completed |
Enrollment | 500 |
Est. completion date | May 2015 |
Est. primary completion date | October 2002 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Household | São Leopoldo | Rio Grande Do Sul |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effectiveness of a nutrition advice programme in exclusive breastfeeding. | Group difference in months of esclusive breastfeeding | 1 year | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 1 year | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 4 years | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 8 years | |
Primary | Effectiveness of a nutrition advice programme in dietary intake | Group differences in energy, fats, protein, carbohidrates and micronutrients intake | 12 years | |
Secondary | Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization. | Group differences in the % of children with each condition | 1 year | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 1 year | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 4 years | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 8 Years | |
Secondary | Effectiveness of a nutrition advice programme in nutritional status | Group differences in the % of overweight and obese children. | 12 Years | |
Secondary | Salty taste preferences | Evaluate the most preferred concentration of salt | 12 years |
Status | Clinical Trial | Phase | |
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