Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00629629
Other study ID # vitolo2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1
Completed NCT01432717 - Study of ACE-536 in Healthy Postmenopausal Women Phase 1