Clinical trial NCT00629629: Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
Official title: Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Breast Feeding, Exclusive
Overweight and Obesity
Keywords: Health Plan Implementation
Feeding and Eating Disorders of Childhood
Breastfeeding
Complementary feeding
Morbidity
Anemia
Public policy
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-03-06
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Effectiveness of a nutrition advice programme in exclusive breastfeeding.
timeFrame: 1 year
measure: Effectiveness of a nutrition advice programme in dietary intake
timeFrame: 1 year
measure: Effectiveness of a nutrition advice programme in dietary intake
timeFrame: 4 years
measure: Effectiveness of a nutrition advice programme in dietary intake
timeFrame: 8 years
measure: Effectiveness of a nutrition advice programme in dietary intake
timeFrame: 12 years
Secondary outcomes:
measure: Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.
timeFrame: 1 year
measure: Effectiveness of a nutrition advice programme in nutritional status
timeFrame: 1 year
measure: Effectiveness of a nutrition advice programme in nutritional status
timeFrame: 4 years
measure: Effectiveness of a nutrition advice programme in nutritional status
timeFrame: 8 Years
measure: Effectiveness of a nutrition advice programme in nutritional status
timeFrame: 12 Years
measure: Salty taste preferences
timeFrame: 12 years
Other outcomes:
Locations:
city: São Leopoldo
country: Brazil
facility: Household
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Márcia R Vitolo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1590/s0102-311x2005000500018. Epub 2005 Sep 12. Portuguese.
citation: Feldens CA, Vitolo 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. doi: 10.1111/j.1600-0528.2006.00337.x.
citation: Vitolo MR, da Costa Louzada ML, Rauber F, Campagnolo PD. Risk factors for high blood pressure in low income children aged 3-4 years. Eur J Pediatr. 2013 Aug;172(8):1097-103. doi: 10.1007/s00431-013-2012-9. Epub 2013 May 1.
citation: Louzada ML, Campagnolo PD, Rauber F, Vitolo MR. Long-term effectiveness of maternal dietary counseling in a low-income population: a randomized field trial. Pediatrics. 2012 Jun;129(6):e1477-84. doi: 10.1542/peds.2011-3063. Epub 2012 May 7.
citation: Bortolini GA, Vitolo MR. The impact of systematic dietary counseling during the first year of life on prevalence rates of anemia and iron deficiency at 12-16 months. J Pediatr (Rio J). 2012 Jan-Feb;88(1):33-9. doi: 10.2223/JPED.2156. Epub 2011 Dec 7.
citation: Vitolo MR, Rauber F, Campagnolo PD, Feldens CA, Hoffman DJ. Maternal dietary counseling in the first year of life is associated with a higher healthy eating index in childhood. J Nutr. 2010 Nov;140(11):2002-7. doi: 10.3945/jn.110.125211. Epub 2010 Sep 15.
citation: Feldens CA, Giugliani ER, Duncan BB, Drachler Mde L, Vitolo MR. Long-term effectiveness of a nutritional program in reducing early childhood caries: a randomized trial. Community Dent Oral Epidemiol. 2010 Aug;38(4):324-32. doi: 10.1111/j.1600-0528.2010.00540.x. Epub 2010 Apr 7.