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Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Centres of Health
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Federal University of Health Science of Porto Alegre.   Recruitment status was  Not yet recruiting

First Received on March 5, 2008.   Last Updated on March 12, 2008   History of Changes
Sponsor: Federal University of Health Science of Porto Alegre
Collaborator: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Information provided by: Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT00635453
  Purpose

This is a randomized controlled trial for the implementation of a dietary advice breastfeeding and healthy weaning practices based on the 'Ten Steps guidelines" which will be provided by health professional during pre-natal care and child care during the first year of the child life. The objectives are increase proportion of infants in exclusive breastfeeding, decrease proportion of morbidity (diarrhea, respiratory problems, fever), use of medications and hospitalization and improve nutritional status. These trial will be conducted in the basic health units in Porto Alegre, capital of the Southern Brazilian state (population of 1.2 million).

Mothers will be identified in the third trimester of pregnancy during the pre-natal and will be informed about the study. Mothers who accept will be registered and they and their children can be evaluated at seven and twelve months of age. The health professional will receive material support to be provided to the all mothers and women in the intervention group will be advised about healthy feeding of children. At twelve months the children will be evaluated about the occurrence of diseases, nutritional assessment and biochemical examinations (parasite) and iron deficiency anemia.

It is expected to find positive changes in feeding practices and health conditions for children in intervention group. The results will enable recognize that it is feasible implement actions in a systematic way in the primary care to promote healthy feeding of infants considering the current conditions in centres of health. In addition to identifying the limits involved in the implementation of the program, creating opportunities for alternative strategies. So the results and analyses the proposals will be forwarded to the State Department of Health.


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

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

Resource links provided by NLM:


Further study details as provided by Federal University of Health Science of Porto Alegre:

Primary Outcome Measures:
  • Effectiveness of a nutrition advice programme in exclusive breastfeeding [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: March 2009 (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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All pregnant women in the last semestrer of gestation.

Exclusion Criteria:

  • HIV-positive mothers
  • congenital malformation
  • infants referred to intensive care unit and multiple pregnancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00635453

Contacts
Contact: Márcia R Vitolo, Doctor 51 - 33038798 vitolo@fffcmpa.tche.br
Contact: Cíntia M Gama, Doctor 51- 33038830 cintia.gama@terra.com.br

Locations
Brazil
The basic health units Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Márcia R Vitolo, Doctor     51 - 33038798     vitolo@fffcmpa.tche.br    
Principal Investigator: Márcia R Vitolo, Doctor            
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Investigators
Principal Investigator: Márcia R Vitolo, Doctor Federal University of Health Sciences of Porto Alegre
  More Information

No publications provided

Responsible Party: Márcia Regina Vitolo, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT00635453     History of Changes
Other Study ID Numbers: vitolo3
Study First Received: March 5, 2008
Last Updated: March 12, 2008
Health Authority: Brazil: Fundação de Amparo à Pesquisa do estado do Rio Grande do Sul

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

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

ClinicalTrials.gov processed this record on February 09, 2012