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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00629629
Enrollment
500
Registered
2008-03-06
Start date
2001-10-31
Completion date
2015-05-31
Last updated
2022-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Breast Feeding, Exclusive, Overweight and Obesity

Keywords

Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breastfeeding, Complementary feeding, Morbidity, Anemia, Public policy

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.

Interventions

BEHAVIORALDietary 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.

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of a nutrition advice programme in exclusive breastfeeding.1 yearGroup difference in months of esclusive breastfeeding
Effectiveness of a nutrition advice programme in dietary intake1 yearGroup differences in energy, fats, protein, carbohidrates and micronutrients intake

Secondary

MeasureTime frameDescription
Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.1 yearGroup differences in the % of children with each condition
Effectiveness of a nutrition advice programme in nutritional status1 yearGroup differences in the % of overweight and obese children.
Salty taste preferences12 yearsEvaluate the most preferred concentration of salt

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026