Feeding and Eating Disorders of Childhood
Conditions
Keywords
Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation
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.
Interventions
BEHAVIORALDietary 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.
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Ministry of Health, Brazil
Federal University of Health Science of Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* All pregnant women in the last trimester of the gestation.
Exclusion criteria
* HIV-positive mothers * congenital malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Breastfeeding at Four Months of Age | Six months after the beginning of the study | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Overweight Children at 12 Months of Age | 12 months after the beginning of the study | 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 | 3 years after the beginning of the study | 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 | 6 years after the beginning of the study | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Food Consumption | Six and twelve months, three and six years after the beginning of the study | 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) |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 360 |
| 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. | 355 |
| Total | 715 |
Baseline characteristics
| Characteristic | I, Intervention | II, Control | Total |
|---|---|---|---|
| Age, Customized < 20 years | 72 Participants | 76 Participants | 148 Participants |
| Age, Customized > = 20 years | 278 Participants | 279 Participants | 557 Participants |
| Race/Ethnicity, Customized Non-White | 146 Participants | 174 Participants | 320 Participants |
| Race/Ethnicity, Customized White | 214 Participants | 181 Participants | 395 Participants |
| Region of Enrollment Brazil | 360 participants | 355 participants | 715 participants |
| Sex: Female, Male Female | 360 Participants | 355 Participants | 715 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 360 | 0 / 355 |
| other Total, other adverse events | 0 / 360 | 0 / 355 |
| serious Total, serious adverse events | 0 / 360 | 0 / 355 |
Outcome results
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.
Time frame: Six months after the beginning of the study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I, Intervention | Exclusive Breastfeeding at Four Months of Age | 140 Participants |
| II, Control | Exclusive Breastfeeding at Four Months of Age | 104 Participants |
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
Time frame: 12 months after the beginning of the study
Population: Analyzed only for participants who underwent anthropometric assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I, Intervention | Number of Overweight Children at 12 Months of Age | 124 Participants |
| II, Control | Number of Overweight Children at 12 Months of Age | 112 Participants |
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
Time frame: 3 years after the beginning of the study
Population: Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I, Intervention | Number of Overweight Children at 3 Years of Age | 101 Participants |
| II, Control | Number of Overweight Children at 3 Years of Age | 97 Participants |
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
Time frame: 6 years after the beginning of the study
Population: Analyzed only for participants who underwent anthropometric assessment and from whom post-baseline data are available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I, Intervention | Number of Overweight Children at 6 Years of Age | 52 Participants |
| II, Control | Number of Overweight Children at 6 Years of Age | 53 Participants |
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)
Time frame: Six and twelve months, three and six years after the beginning of the study