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

October 10, 2022 updated by: Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rio Grande Do Sul
      • São Leopoldo, Rio Grande Do Sul, Brazil
        • Household

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Márcia R Vitolo, PhD, Federal University of Health Sciences of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 6, 2008

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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