Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers

August 18, 2021 updated by: Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Cluster randomized controlled trial targeting selected primary health care centers in Porto Alegre, South of Brazil, a city of 1.4 million inhabitants. The trial included health centers that provide primary care services predominantly to low-income families.Physicians, nurses and administrative staff of all intervention health centers participated in a training in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.

Following staff training at the intervention sites, interviewers visited the intervention and control health centers from April to December 2008 to identify and enroll pregnant women who were in the last trimester of pregnancy. 98% of eligible pregnant women agreed to participate and answered a questionnaire about their socioeconomic status and expected due date. Addresses and telephone numbers were obtained in order to schedule subsequent home visits.

Data Collection:

Maternal interviews using structured questionnaires were conducted at baseline (during pregnancy - 2008) and at follow-up home-visits at mean child ages six months (2008/2009), 12 months (2009/2010) , three years (2011/2012) and six years (2014/2015) by field workers who were not involved in the intervention and who were unaware of the group allocations.

Study Type

Interventional

Enrollment (Actual)

715

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
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • The health units

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All pregnant women in the last trimester of the gestation.

Exclusion Criteria:

  • HIV-positive mothers
  • congenital malformation

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I, Intervention
Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions.
The content of the dietary intervention follows the recommendations of the guidelines of the Brazilian Ministry of Health for healthy feeding of children younger then two years.
Other Names:
  • Infant Nutrition Programme
No Intervention: II, Control
Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive Breastfeeding at Four Months of Age
Time Frame: Six months after the beginning of the study
Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth.
Six months after the beginning of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Overweight Children at 12 Months of Age
Time Frame: 12 months after the beginning of the study
The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age
12 months after the beginning of the study
Number of Overweight Children at 3 Years of Age
Time Frame: 3 years after the beginning of the study
The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age
3 years after the beginning of the study
Number of Overweight Children at 6 Years of Age
Time Frame: 6 years after the beginning of the study
The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age
6 years after the beginning of the study

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food Consumption
Time Frame: Six and twelve months, three and six years after the beginning of the study
Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food)
Six and twelve months, three and six years after the beginning of the study

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Márcia R Vitolo, Postdoctoral, 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.

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 (Actual)

March 1, 2008

Primary Completion (Actual)

February 28, 2010

Study Completion (Actual)

July 2, 2015

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

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.

Clinical Trials on Feeding and Eating Disorders of Childhood

Clinical Trials on Dietary Advice

Subscribe