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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629629
• Other study ID #: vitolo2
• Status: Completed
• Phase: N/A
• Start date: October 2001
• Est. completion date: May 2015

Study information

• Verified date: October 2022
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Anemia
• Breast Feeding, Exclusive
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Dietary Advice
Step 1 - Provide Exclusive breastfeeding up to 6 mo. Step 2- After 6 mo, gradually introduce complementary foods and continue breastfeeding up to 2 y or more. Step 3 - Complementary foods should be given 3 times a day (cereals, beans, fruits, and vegetables) if the child is breastfed, and 5 times a day if not. Step 4- Mealtimes must be adjusted to the children's cues of hunger and satiety. Step 5: Foods should gradually get thicker up to the time when the child is able to eat a family meal. Complementary foods should not be liquefied. Step 6: A large variety of healthy foods should be given daily to guarantee the intake of different nutrients. Step 7: Different fruits and vegetables should be offered daily. Step 8: Sugar, sweets, soft drinks, salty snacks, cookies, and processed and fried foods must be avoided. Step 9: Good hygiene practices in food preparation and handling. Step 10: Adequate feeding during child illness.

Locations

Country	Name	City	State
Brazil	Household	São Leopoldo	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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

Outcome

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