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

Feeding and Eating Disorders of Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635453
• Other study ID #: vitolo3
• Status: Completed
• Phase: N/A
• Start date: March 1, 2008
• Est. completion date: July 2, 2015

Study information

• Verified date: August 2021
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: July 2, 2015
• Est. primary completion date: February 28, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• HIV-positive mothers

• congenital malformation

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding and Eating Disorders of Childhood

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.

Locations

Country	Name	City	State
Brazil	The health units	Porto Alegre	Rio Grande Do Sul

Sponsors (3)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
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.	Six months after the beginning of the study
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	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	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	6 years after the beginning of the study