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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Márcia R Vitolo, Doctor | 51 - 33038798 | vitolo@fffcmpa.tche.br |
| Contact: Cíntia M Gama, Doctor | 51- 33038830 | cintia.gama@terra.com.br |
| 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 | |
| Principal Investigator: | Márcia R Vitolo, Doctor | Federal University of Health Sciences of Porto Alegre |
More Information
| 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 |
|
Breast Feeding Child Infant Nutrition Physiology |
Public Health Morbidity Health Plan Implementation |
|
Eating Disorders Feeding and Eating Disorders of Childhood Mental Disorders Mental Disorders Diagnosed in Childhood |