Clinical trial NCT00635453: 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
Overall status: COMPLETED
Phase: NA
Conditions: Feeding and Eating Disorders of Childhood
Keywords: Breast Feeding
Child
Infant Nutrition Physiology
Public Health
Morbidity
Health Plan Implementation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Ministry of Health, Brazil
First posted: 2008-03-13
Enrollment: 715
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* HIV-positive mothers
* congenital malformation

Primary outcomes:
measure: Exclusive Breastfeeding at Four Months of Age
timeFrame: Six months after the beginning of the study
Secondary outcomes:
measure: Number of Overweight Children at 12 Months of Age
timeFrame: 12 months after the beginning of the study
measure: Number of Overweight Children at 3 Years of Age
timeFrame: 3 years after the beginning of the study
measure: Number of Overweight Children at 6 Years of Age
timeFrame: 6 years after the beginning of the study
Other outcomes:
measure: Food Consumption
timeFrame: Six and twelve months, three and six years after the beginning of the study
Locations:
city: Porto Alegre
country: Brazil
facility: The health units
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Márcia R Vitolo, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.