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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Ministry of Health, Brazil | OTHER_GOV |
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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.
Cluster randomized controlled trial targeting selected primary health care centers in Porto Alegre, South of Brazil, a city of 1.4 million inhabitants. The trial included health centers that provide primary care services predominantly to low-income families.Physicians, nurses and administrative staff of all intervention health centers participated in a training in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.
Following staff training at the intervention sites, interviewers visited the intervention and control health centers from April to December 2008 to identify and enroll pregnant women who were in the last trimester of pregnancy. 98% of eligible pregnant women agreed to participate and answered a questionnaire about their socioeconomic status and expected due date. Addresses and telephone numbers were obtained in order to schedule subsequent home visits.
Data Collection:
Maternal interviews using structured questionnaires were conducted at baseline (during pregnancy - 2008) and at follow-up home-visits at mean child ages six months (2008/2009), 12 months (2009/2010) , three years (2011/2012) and six years (2014/2015) by field workers who were not involved in the intervention and who were unaware of the group allocations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I, Intervention | Experimental | Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. |
|
| II, Control | No Intervention | Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary Advice | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exclusive Breastfeeding at Four Months of Age | Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth. | Six months after the beginning of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Overweight Children at 12 Months of Age | The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age | 12 months after the beginning of the study |
| Number of Overweight Children at 3 Years of Age |
| Measure | Description | Time Frame |
|---|---|---|
| Food Consumption | Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food) | Six and twelve months, three and six years after the beginning of the study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Márcia R Vitolo, Postdoctoral | Federal University of Health Sciences of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The health units | Porto Alegre | Rio Grande do Sul | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37354762 | Derived | Valmorbida JL, Baratto PS, Leffa PS, Sangalli CN, Silva JA, Vitolo MR. Consumption of ultraprocessed food is associated with higher blood pressure among 6-year-old children from southern Brazil. Nutr Res. 2023 Aug;116:60-68. doi: 10.1016/j.nutres.2023.05.012. Epub 2023 May 27. | |
| 34034359 | Derived | Sangalli CN, Leffa PS, Valmorbida JL, Lumey LH, Vitolo MR. Impact of promoting healthy infant feeding practices on energy intake and anthropometric measures of children up to 6 years of age: A randomised controlled trial. J Hum Nutr Diet. 2021 Oct;34(5):771-783. doi: 10.1111/jhn.12881. Epub 2021 May 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | I, Intervention | Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. 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. |
| FG001 | II, Control | Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I, Intervention | Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Exclusive Breastfeeding at Four Months of Age | Effectiveness of the nutrition advice programme will be measured comparing the number of mothers from Intervention and control groups reporting exclusively breastfeeding their infants four months after childbirth. | Posted | Count of Participants | Participants | Six months after the beginning of the study |
|
6 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | I, Intervention | Physicians, nurses and administrative staff of all intervention health centers participated in a training of Dietary Advice in January 2008 based on the "Ten Steps for Healthy Feeding for Brazilian Children from Birth to Two Years of Age" guideline.13 An experienced nutritionist conducted a standardized session for the health care team to outline the "Ten Steps" recommendations and strategies and to provide suggestions how best to incorporate these into the consultations. Printed materials were provided to the Health Care Centers for use by these professionals and for access to the Brazilian Ministry of Healthy Nutrition Department´s website. Health staff members received a pocket guide for use during the appointments and waiting room sessions. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcia Vitolo | Universidade Federal de Ciências da Saúde de Porto Alegre | +555133038798 | marciavitolo@hotmail.com |
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| ID | Term |
|---|---|
| D019959 | Feeding and Eating Disorders of Childhood |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age |
| 3 years after the beginning of the study |
| Number of Overweight Children at 6 Years of Age | The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age | 6 years after the beginning of the study |
| 30182376 | Derived | Ferreira VR, Sangalli CN, Leffa PS, Rauber F, Vitolo MR. The impact of a primary health care intervention on infant feeding practices: a cluster randomised controlled trial in Brazil. J Hum Nutr Diet. 2019 Feb;32(1):21-30. doi: 10.1111/jhn.12595. Epub 2018 Sep 4. |
| 25388499 | Derived | Chaffee BW, Vitolo MR, Feldens CA. The Porto Alegre Early Life Nutrition and Health Study. Rev Bras Epidemiol. 2014 Dec;17(4):1015-8. doi: 10.1590/1809-4503201400040018. |
| 23690364 | Derived | Chaffee BW, Feldens CA, Vitolo MR. Cluster-randomized trial of infant nutrition training for caries prevention. J Dent Res. 2013 Jul;92(7 Suppl):29S-36S. doi: 10.1177/0022034513484331. Epub 2013 May 20. |
| BG001 | II, Control | Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | II, Control | Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics. |
|
|
| Secondary | Number of Overweight Children at 12 Months of Age | The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 12 months of age | Analyzed only for participants who underwent anthropometric assessment | Posted | Count of Participants | Participants | 12 months after the beginning of the study |
|
|
|
| Secondary | Number of Overweight Children at 3 Years of Age | The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 3 years of age | Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available. | Posted | Count of Participants | Participants | 3 years after the beginning of the study |
|
|
|
| Secondary | Number of Overweight Children at 6 Years of Age | The effectiveness of the program will be evaluated by comparing number of overweight children in the intervention and control groups at 6 years of age | Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available. | Posted | Count of Participants | Participants | 6 years after the beginning of the study |
|
|
|
| Other Pre-specified | Food Consumption | Effectiveness of a nutrition advice programme will be evaluated by comparing the food consumption differences between the intervention and control groups (nutrient and grams of non recommended food) | Not Posted | Six and twelve months, three and six years after the beginning of the study | Participants |
| 0 |
| 360 |
| 0 |
| 360 |
| 0 |
| 360 |
| EG001 | II, Control | Healthcare centers randomized to the non-intervention group continued their routine medical assistance without any involvement of the research team. No materials were provided to these clinics. | 0 | 355 | 0 | 355 | 0 | 355 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |