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Completed

NCT Number: NCT00635453

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

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.

Completed

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The health units

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • HIV-positive mothers
  • congenital malformation

Treatment and study plan

Dietary Advice

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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. 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

Other outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
  • Ministry of Health, Brazil

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Mar 13, 2008
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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