search
Back to results

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

Primary Purpose

Feeding and Eating Disorders of Childhood

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dietary Advice
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Feeding and Eating Disorders of Childhood focused on measuring Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All pregnant women in the last trimester of the gestation.

Exclusion Criteria:

  • HIV-positive mothers
  • congenital malformation

Sites / Locations

  • The health units

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

I, Intervention

II, Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
March 5, 2008
Last Updated
August 18, 2021
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
search

1. Study Identification

Unique Protocol Identification Number
NCT00635453
Brief Title
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Official Title
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2008 (Actual)
Primary Completion Date
February 28, 2010 (Actual)
Study Completion Date
July 2, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding and Eating Disorders of Childhood
Keywords
Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
715 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I, Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
II, Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary Advice
Other Intervention Name(s)
Infant Nutrition Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exclusive Breastfeeding at Four Months of Age
Description
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.
Time Frame
Six months after the beginning of the study
Secondary Outcome Measure Information:
Title
Number of Overweight Children at 12 Months of Age
Description
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
Time Frame
12 months after the beginning of the study
Title
Number of Overweight Children at 3 Years of Age
Description
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
Time Frame
3 years after the beginning of the study
Title
Number of Overweight Children at 6 Years of Age
Description
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
Time Frame
6 years after the beginning of the study
Other Pre-specified Outcome Measures:
Title
Food Consumption
Description
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)
Time Frame
Six and twelve months, three and six years after the beginning of the study

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All pregnant women in the last trimester of the gestation. Exclusion Criteria: HIV-positive mothers congenital malformation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Márcia R Vitolo, Postdoctoral
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
The health units
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34034359
Citation
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.
Results Reference
derived
PubMed Identifier
30182376
Citation
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.
Results Reference
derived
PubMed Identifier
25388499
Citation
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.
Results Reference
derived
PubMed Identifier
23690364
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs