Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
This study has been completed.
Sponsor:
Federal University of Health Science of Porto Alegre
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
ClinicalTrials.gov Identifier:
NCT00635453
First received: March 5, 2008
Last updated: July 17, 2012
Last verified: July 2012
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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 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 Health Centers |
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 at six months of age [ Time Frame: Six months after the beginning of the study ] [ Designated as safety issue: Yes ]
- Effectiveness of a nutrition advice programme in exclusive breastfeeding at twelve months of age [ Time Frame: Twelve months after the beginning of the study ] [ 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 at twelve months of age [ Time Frame: Twelve months after the beginning of the study ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
| 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| Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | March 5, 2008 |
| Last Updated: | July 17, 2012 |
| Health Authority: | Brazil: Ministry of Health |
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 May 16, 2013