Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
This study has been withdrawn prior to enrollment.
(Funding was canceled and no resources are available.)
Sponsor:
Federal University of Health Science of Porto Alegre
Information provided by:
Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier:
NCT00635518
First received: March 5, 2008
Last updated: June 22, 2011
Last verified: May 2011
| Tracking Information | |||||
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| First Received Date ICMJE | March 5, 2008 | ||||
| Last Updated Date | June 22, 2011 | ||||
| Start Date ICMJE | March 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE |
Prevalence of overweight [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00635518 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Feeding practices at one year of live [ Time Frame: one year ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants | ||||
| Official Title ICMJE | Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE | Breast Feeding | ||||
| Intervention ICMJE | Behavioral: Ten Steps for Healthy Feeding children programme
Ten Steps for Healthy Feeding children
Other Name: Infant Nutrition Programme |
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| Study Arm (s) | I, Intervention
Intervention: Behavioral: Ten Steps for Healthy Feeding children programme |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 329 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - All pregnant women in the last quarter of the gestation. Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00635518 | ||||
| Other Study ID Numbers ICMJE | vitolo1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Márcia Regina Vitolo, Federal University of Health Science of Porto Alegre | ||||
| Study Sponsor ICMJE | Federal University of Health Science of Porto Alegre | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of Health Science of Porto Alegre | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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