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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00635453
First Posted: March 13, 2008
Last Update Posted: July 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Ministry of Health, Brazil
Information provided by (Responsible Party):
Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre
  Purpose
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.

Condition Intervention
Feeding and Eating Disorders of Childhood Behavioral: Dietary Advice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers

Further study details as provided by Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Effectiveness of a nutrition advice programme in exclusive breastfeeding at six months of age [ Time Frame: Six months after the beginning of the study ]
  • Effectiveness of a nutrition advice programme in exclusive breastfeeding at twelve months of age [ Time Frame: Twelve months after the beginning of the study ]

Secondary Outcome Measures:
  • Effectiveness of a nutrition advice programme in decrease of morbidity (diarrhea, respiratory problems and fever), use of medication, anemia and hospitalization and improve nutritional status at twelve months of age [ Time Frame: Twelve months after the beginning of the study ]
  • Effectiveness of a nutrition advice programme in decrease of morbidity (diarrhea, respiratory problems and fever), use of medication, anemia and hospitalization and improve nutritional status at six months of age [ Time Frame: Six months after the beginning of the study ]

Other Outcome Measures:
  • Effectiveness of a nutrition advice programme on food consumption and nutritional status of preschool children. [ Time Frame: Three years after the beginning of the study ]

Enrollment: 474
Study Start Date: March 2008
Study Completion Date: June 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I, Intervention Behavioral: Dietary Advice
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 Name: Infant Nutrition Programme

Detailed Description:

A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".

Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.

When the children are 3 years old, the mothers will be interviewed at home again and the mothers and the children will be evaluated.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • HIV-positive mothers
  • congenital malformation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635453


Locations
Brazil
The health units
Porto Alegre, Rio Grande do Sul, Brazil
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Ministry of Health, Brazil
Investigators
Principal Investigator: Márcia R Vitolo, Postdoctoral Federal University of Health Sciences of Porto Alegre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcia Regina Vitolo, Professor, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT00635453     History of Changes
Other Study ID Numbers: vitolo3
First Submitted: March 5, 2008
First Posted: March 13, 2008
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre:
Breast Feeding
Child
Infant Nutrition Physiology
Public Health
Morbidity
Health Plan Implementation

Additional relevant MeSH terms:
Feeding and Eating Disorders
Feeding and Eating Disorders of Childhood
Mental Disorders