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AnemiaNCT00629629

Impacts of the 10 Steps for Healthy Feeding in Infants: a Randomized Field Trial

A study testing Dietary Advice in people with Anemia and Breast Feeding, Exclusive, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Dietary Advice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteBrazil
Study dates
Oct 2001to May 2015
Phase
Interventional
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Newborn infants with birth weight ≥ 2.500 g and gestational age ≥ 37 weeks were considered eligible for the study.

Who cannot join

  • HIV-positive mothers
  • Congenital malformation
  • Infants referred to intensive care unit
  • Multiple pregnancy.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Household

    São Leopoldo, Rio Grande do Sul

Other trials in Brazil

About this study

This study assesses the effectiveness of a nutrition advice programme - The ten steps for healthy feeding of children under two years old - on nutritional status, diet, and morbidity history of children. This is a randomized controlled trial in mostly socioeconomic deprived families (intervention=200; controls=300). Mothers of the intervention group received dietary counseling in the first year of life. Both groups received routine care by their paediatricians and research assessment at 6 and 12 months, 4 years, 8 years and 12 years of age.

Being tested
Dietary Advice
Keywords
Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breastfeeding, Complementary feeding, Morbidity, Anemia, Public policy
Medical subject headings
Anemia, Breast Feeding, Overweight, Obesity, Feeding and Eating Disorders of Childhood

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary AdviceBehavioural

    Step 1 - Provide Exclusive breastfeeding up to 6 mo.

    Step 2- After 6 mo, gradually introduce complementary foods and continue breastfeeding up to 2 y or more.

    Step 3 - Complementary foods should be given 3 times a day (cereals, beans, fruits, and vegetables) if the child is breastfed, and 5 times a day if not.

    Step 4- Mealtimes must be adjusted to the children's cues of hunger and satiety.

    Step 5: Foods should gradually get thicker up to the time when the child is able to eat a family meal. Complementary foods should not be liquefied.

    Step 6: A large variety of healthy foods should be given daily to guarantee the intake of different nutrients.

    Step 7: Different fruits and vegetables should be offered daily. Step 8: Sugar, sweets, soft drinks, salty snacks, cookies, and processed and fried foods must be avoided.

    Step 9: Good hygiene practices in food preparation and handling.

    Step 10: Adequate feeding during child illness.

Study groups in NCT00629629
Study groupRoleWhat they receive
InterventionExperimentalMothers in the intervention group received dietary advice based on Brazilian guidelines ["Ten steps for the healthy eating: Feeding guidelines for Brazilian children from birth to two years" ] during monthly home visits from 2 weeks to 6 months postpartum and then every 2 months thereafter until 1 y postpartum.
Receives: Behavioral: Dietary Advice
ControlNo interventionMothers in the control group received routine medical assistance without any involvement of the research team. The study staff provided no materials to mothers on the Control Arm.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of a nutrition advice programme in exclusive breastfeeding.

    Group difference in months of esclusive breastfeeding

    Measured: 1 year

  2. Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    Measured: 1 year

  3. Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    Measured: 4 years

  4. Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    Measured: 8 years

  5. Effectiveness of a nutrition advice programme in dietary intake

    Group differences in energy, fats, protein, carbohidrates and micronutrients intake

    Measured: 12 years

Secondary outcomes (6)

  1. Effectiveness of a nutrition advice programme in occurrence of diarrhea, respiratory problems, use of medication, dental caries,anemia and hospitalization.

    Group differences in the % of children with each condition

    Measured: 1 year

  2. Effectiveness of a nutrition advice programme in nutritional status

    Group differences in the % of overweight and obese children.

    Measured: 1 year

  3. Effectiveness of a nutrition advice programme in nutritional status

    Group differences in the % of overweight and obese children.

    Measured: 4 years

  4. Effectiveness of a nutrition advice programme in nutritional status

    Group differences in the % of overweight and obese children.

    Measured: 8 Years

  5. Effectiveness of a nutrition advice programme in nutritional status

    Group differences in the % of overweight and obese children.

    Measured: 12 Years

  6. Salty taste preferences

    Evaluate the most preferred concentration of salt

    Measured: 12 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2008 (estimated)
  2. Study startOct 2001
  3. Primary completionOct 2002
  4. Study completionMay 2015

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00629629
Sponsor's protocol ID
vitolo2
Status last verified
Oct 2022
First submitted
5 Mar 2008
Last updated
13 Oct 2022
Results posted
No
Data monitoring committee
No

Publications

  • Vitolo MR, Bortolini GA, Feldens CA, Drachler Mde L. [Impacts of the 10 Steps to Healthy Feeding in Infants: a randomized field trial]. Cad Saude Publica. 2005 Sep-Oct;21(5):1448-57. doi: 10.1590/s0102-311x2005000500018. Epub 2005 Sep 12. Portuguese.

    PubMed 16158151

  • Feldens CA, Vitolo MR, Drachler Mde L. A randomized trial of the effectiveness of home visits in preventing early childhood caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):215-23. doi: 10.1111/j.1600-0528.2006.00337.x.

    PubMed 17518968

  • Valmorbida JL, Sangalli CN, Leffa PS, Baratto PS, Rauber F, Mennella JA, Vitolo MR. Sodium Intake Tracked from Infancy and Salt Taste Preference during Adolescence: Follow-up of a Randomized Controlled Field Trial in Brazil. Curr Dev Nutr. 2022 Dec 22;7(1):100011. doi: 10.1016/j.cdnut.2022.100011. eCollection 2023 Jan.

    PubMed 37181123

  • Vitolo MR, da Costa Louzada ML, Rauber F, Campagnolo PD. Risk factors for high blood pressure in low income children aged 3-4 years. Eur J Pediatr. 2013 Aug;172(8):1097-103. doi: 10.1007/s00431-013-2012-9. Epub 2013 May 1.

    PubMed 23636283

  • Louzada ML, Campagnolo PD, Rauber F, Vitolo MR. Long-term effectiveness of maternal dietary counseling in a low-income population: a randomized field trial. Pediatrics. 2012 Jun;129(6):e1477-84. doi: 10.1542/peds.2011-3063. Epub 2012 May 7.

    PubMed 22566413

  • Bortolini GA, Vitolo MR. The impact of systematic dietary counseling during the first year of life on prevalence rates of anemia and iron deficiency at 12-16 months. J Pediatr (Rio J). 2012 Jan-Feb;88(1):33-9. doi: 10.2223/JPED.2156. Epub 2011 Dec 7.

    PubMed 22159301

  • Vitolo MR, Rauber F, Campagnolo PD, Feldens CA, Hoffman DJ. Maternal dietary counseling in the first year of life is associated with a higher healthy eating index in childhood. J Nutr. 2010 Nov;140(11):2002-7. doi: 10.3945/jn.110.125211. Epub 2010 Sep 15.

    PubMed 20844187

  • Feldens CA, Giugliani ER, Duncan BB, Drachler Mde L, Vitolo MR. Long-term effectiveness of a nutritional program in reducing early childhood caries: a randomized trial. Community Dent Oral Epidemiol. 2010 Aug;38(4):324-32. doi: 10.1111/j.1600-0528.2010.00540.x. Epub 2010 Apr 7.

    PubMed 20406273

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Advice in people with Anemia and Breast Feeding, Exclusive, 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 4 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 13 Oct 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Effectiveness of a nutrition advice programme in exclusive breastfeeding. (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT00629629, which also lists 8 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 13 Oct 2022.

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