- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629629
Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
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São Leopoldo, Rio Grande Do Sul, Brazil
- Household
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Mothers in the intervention group received dietary advice based on Brazilian guidelines ["Ten steps for the healthy eating: Feeding guidelines for Brazilian children from birth to two years" ] during monthly home visits from 2 weeks to 6 months postpartum and then every 2 months thereafter until 1 y postpartum.
|
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. |
No Intervention: Control
Mothers in the control group received routine medical assistance without any involvement of the research team.
The study staff provided no materials to mothers on the Control Arm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of a nutrition advice programme in exclusive breastfeeding.
Time Frame: 1 year
|
Group difference in months of esclusive breastfeeding
|
1 year
|
Effectiveness of a nutrition advice programme in dietary intake
Time Frame: 1 year
|
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
|
1 year
|
Effectiveness of a nutrition advice programme in dietary intake
Time Frame: 4 years
|
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
|
4 years
|
Effectiveness of a nutrition advice programme in dietary intake
Time Frame: 8 years
|
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
|
8 years
|
Effectiveness of a nutrition advice programme in dietary intake
Time Frame: 12 years
|
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
|
12 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.
Time Frame: 1 year
|
Group differences in the % of children with each condition
|
1 year
|
Effectiveness of a nutrition advice programme in nutritional status
Time Frame: 1 year
|
Group differences in the % of overweight and obese children.
|
1 year
|
Effectiveness of a nutrition advice programme in nutritional status
Time Frame: 4 years
|
Group differences in the % of overweight and obese children.
|
4 years
|
Effectiveness of a nutrition advice programme in nutritional status
Time Frame: 8 Years
|
Group differences in the % of overweight and obese children.
|
8 Years
|
Effectiveness of a nutrition advice programme in nutritional status
Time Frame: 12 Years
|
Group differences in the % of overweight and obese children.
|
12 Years
|
Salty taste preferences
Time Frame: 12 years
|
Evaluate the most preferred concentration of salt
|
12 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Márcia R Vitolo, PhD, Federal University of Health Sciences of Porto Alegre
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- vitolo2
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