Impact of the Ten Steps for Healthy Feeding of Children Younger Than Two Years in Health Centers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of the Ten Steps for Healthy Feeding of Children Younger Than Two Years in Health Centers

Conditions
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Feeding and Eating Disorders of Childhood

Intervention / Treatment
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* Behavioral: Dietary Advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pregnant women in the last trimester of the gestation. Exclusion Criteria: HIV-positive mothers congenital malformation
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I, Intervention<br>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. | Behavioral: Dietary Advice<br>* 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.<br>* Other names: Infant Nutrition Programme;|
| No Intervention: II, Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation