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

Not Applicable

Completed

• Conditions: Anemia; Overweight and Obesity; Breast Feeding, Exclusive

• Registration Number: NCT00629629
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Primary Completion: 2002-10
• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Study Completion: 2015-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of a nutrition advice programme in exclusive breastfeeding.	1 year	Group difference in months of esclusive breastfeeding
Effectiveness of a nutrition advice programme in dietary intake	12 years	Group differences in energy, fats, protein, carbohidrates and micronutrients intake

Secondary Outcome Measures

Name	Time	Method
Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.	1 year	Group differences in the % of children with each condition
Effectiveness of a nutrition advice programme in nutritional status	12 Years	Group differences in the % of overweight and obese children.
Salty taste preferences	12 years	Evaluate the most preferred concentration of salt

Trial Locations

Locations (1)

Household; 🇧🇷 São Leopoldo, Rio Grande Do Sul, Brazil