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

Federal University of Health Science of Porto Alegre

Status: Completed

Conditions: Anemia; Breast Feeding, Exclusive; Overweight and Obesity

Treatments: Behavioral: Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT00629629

vitolo2

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Volunteers: Accepts 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Intervention

Experimental group

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.

Treatment:

Behavioral: Dietary Advice

Control

No Intervention group

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.