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

Primary Purpose

Anemia, Breast Feeding, Exclusive, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary Advice
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anemia focused on measuring Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breastfeeding, Complementary feeding, Morbidity, Anemia, Public policy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Household

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effectiveness of a nutrition advice programme in exclusive breastfeeding.
Group difference in months of esclusive breastfeeding
Effectiveness of a nutrition advice programme in dietary intake
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Effectiveness of a nutrition advice programme in dietary intake
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Effectiveness of a nutrition advice programme in dietary intake
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Effectiveness of a nutrition advice programme in dietary intake
Group differences in energy, fats, protein, carbohidrates and micronutrients intake

Secondary Outcome Measures

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
Effectiveness of a nutrition advice programme in nutritional status
Group differences in the % of overweight and obese children.
Effectiveness of a nutrition advice programme in nutritional status
Group differences in the % of overweight and obese children.
Effectiveness of a nutrition advice programme in nutritional status
Group differences in the % of overweight and obese children.
Effectiveness of a nutrition advice programme in nutritional status
Group differences in the % of overweight and obese children.
Salty taste preferences
Evaluate the most preferred concentration of salt

Full Information

First Posted
March 5, 2008
Last Updated
October 10, 2022
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT00629629
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
October 2002 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Breast Feeding, Exclusive, Overweight and Obesity
Keywords
Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breastfeeding, Complementary feeding, Morbidity, Anemia, Public policy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of a nutrition advice programme in exclusive breastfeeding.
Description
Group difference in months of esclusive breastfeeding
Time Frame
1 year
Title
Effectiveness of a nutrition advice programme in dietary intake
Description
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Time Frame
1 year
Title
Effectiveness of a nutrition advice programme in dietary intake
Description
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Time Frame
4 years
Title
Effectiveness of a nutrition advice programme in dietary intake
Description
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Time Frame
8 years
Title
Effectiveness of a nutrition advice programme in dietary intake
Description
Group differences in energy, fats, protein, carbohidrates and micronutrients intake
Time Frame
12 years
Secondary Outcome Measure Information:
Title
Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.
Description
Group differences in the % of children with each condition
Time Frame
1 year
Title
Effectiveness of a nutrition advice programme in nutritional status
Description
Group differences in the % of overweight and obese children.
Time Frame
1 year
Title
Effectiveness of a nutrition advice programme in nutritional status
Description
Group differences in the % of overweight and obese children.
Time Frame
4 years
Title
Effectiveness of a nutrition advice programme in nutritional status
Description
Group differences in the % of overweight and obese children.
Time Frame
8 Years
Title
Effectiveness of a nutrition advice programme in nutritional status
Description
Group differences in the % of overweight and obese children.
Time Frame
12 Years
Title
Salty taste preferences
Description
Evaluate the most preferred concentration of salt
Time Frame
12 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márcia R Vitolo, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Household
City
São Leopoldo
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
16158151
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.
Results Reference
result
PubMed Identifier
17518968
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.
Results Reference
result
PubMed Identifier
23636283
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.
Results Reference
derived
PubMed Identifier
22566413
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.
Results Reference
derived
PubMed Identifier
22159301
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.
Results Reference
derived
PubMed Identifier
20844187
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.
Results Reference
derived
PubMed Identifier
20406273
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.
Results Reference
derived

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

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