Feeding and Eating Disorders of ChildhoodNCT00635453
Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
A study testing Dietary Advice in people with Feeding and Eating Disorders of Childhood, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Feeding and Eating Disorders of Childhood
- What is being tested?
- Dietary Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 715 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2008to 2 Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All pregnant women in the last trimester of the gestation.
Who cannot join
- HIV-positive mothers
- congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Dietary Advice
- Keywords
- Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation
- Medical subject headings
- Feeding and Eating Disorders of Childhood, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary AdviceBehavioural
Also called Infant Nutrition Programme
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.
| Study group | Role | What they receive |
|---|---|---|
| I, Intervention | Experimental | 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. Receives: Behavioral: Dietary Advice |
| II, Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months after the beginning of the study
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 years after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study start1 Mar 2008
- Primary completion28 Feb 2010
- Study completion2 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Ministry of Health, Brazil
- Responsible party
- Principal investigator, Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre
- Investigators
- Márcia R Vitolo, Postdoctoral, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635453
- Sponsor's protocol ID
- vitolo3
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2008
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Valmorbida JL, Baratto PS, Leffa PS, Sangalli CN, Silva JA, Vitolo MR. Consumption of ultraprocessed food is associated with higher blood pressure among 6-year-old children from southern Brazil. Nutr Res. 2023 Aug;116:60-68. doi: 10.1016/j.nutres.2023.05.012. Epub 2023 May 27.
PubMed 37354762Sangalli 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.
PubMed 34034359Ferreira 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.
PubMed 30182376Chaffee 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.
PubMed 25388499Chaffee 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.
PubMed 23690364
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the "Ten Steps for Healthy Feeding of Children Younger Than Two Years" in Health Centers
- ClinicalTrials.gov ID
- NCT00635453
- Acronym / sponsor ID
- vitolo3
- Keywords
- Breast Feeding, Child, Infant Nutrition Physiology, Public Health, Morbidity, Health Plan Implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Ministry of Health, Brazil
- Study start
- 1 Mar 2008 (actual)
- Primary completion
- 28 Feb 2010 (actual)
- Study completion
- 2 Jul 2015 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 22 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I, Intervention | Experimental | Behavioral: Dietary AdvicePhysicians, 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. |
| II, Control | No intervention | –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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women in the last trimester of the gestation.
Key exclusion criteria (2 listed)
- HIV-positive mothers
- congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary AdviceAlso: Infant Nutrition ProgrammeThe 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. | Behavioural | I, Intervention |
Primary outcome
Exclusive Breastfeeding at Four Months of Age
Time frame: 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.
3 secondary outcomes
Number of Overweight Children at 12 Months of Age
Time frame: 12 months after the beginning of the study
Number of Overweight Children at 3 Years of Age
Time frame: 3 years after the beginning of the study
Number of Overweight Children at 6 Years of Age
Time frame: 6 years after the beginning of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37354762Valmorbida JL, Baratto PS, Leffa PS, Sangalli CN, Silva JA, Vitolo MR. Consumption of ultraprocessed food is associated with higher blood pressure among 6-year-old children from southern Brazil. Nutr Res. 2023 Aug;116:60-68. doi: 10.1016/j.nutres.2023.05.012. Epub 2023 May 27.
- Derived from this study: PubMed 34034359Sangalli 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.
- Derived from this study: PubMed 30182376Ferreira 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.
- Derived from this study: PubMed 25388499Chaffee 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.
- Derived from this study: PubMed 23690364Chaffee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Márcia R Vitolo, Postdoctoral principal investigator
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Advice in people with Feeding and Eating Disorders of Childhood, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive Breastfeeding at Four Months of Age (time frame: Six months after the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00635453, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.