AzTrials
AzTrials

Infant Nutrition DisordersNCT03841123

Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods

A study testing Dietary Counseling in people with Infant Nutrition Disorders and Feeding Patterns, 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
Search all trials

Trial summary

The purpose of the study is to prevent the early introduction of added sugar and ultra-processed foods and evaluate the impact on breastfeeding duration, complementary feeding quality, growth and prevalence of caries during the first year of life. Read more about this study

Who is it for?
Ages 1 hour to 72 hoursHealthy volunteers can take part
What is being tested?
Dietary Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
516 participants
Where
1 siteBrazil
Study dates
10 Sep 2018to 25 Feb 2020
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 1 hour to 72 hours
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Newborns with gestational age ≥ 37 weeks
  • single birth
  • Mother with at least 18 years old

Who cannot join

  • Mothers with HIV or HTLV1 positive
  • Infants with clinical occurrences or other conditions that prohibit breastfeeding or requires specific dietary treatment.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Federal University of Health Science of Porto Alegre

    Porto Alegre, Centro Histórico, 90050-170

Other trials in Brazil

About this study

Official title: Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial

The purpose of the study is to prevent the early introduction of added sugar and ultra-processed foods and evaluate the impact on breastfeeding duration, complementary feeding quality, growth and prevalence of caries during the first year of life.

Read the detailed description

This randomized field trial will be performed at the maternity wards of Friendly Hospitals Initiative in three regions of Brazil: North, Northeast and South. After delivery, mothers who accepted to participate in the study will be randomized into control and intervention groups.It will be performed a weekly block randomization to prevent the contamination of information among mothers of different groups in the same facility. The intervention mothers will be advised not to give added sugar and ultra-processed foods during the first year of life, including a leaflet with colored images as a reminder for mothers. The control group mothers will not receive the study intervention but will be have all the routine health assistance of the maternity. At 6 months and 12 months, mothers of both groups will be visited in their homes and dietary evaluation and anthropometric measurements of their babies will be assessed. At 12 months of age the infants will have dental examinations and hemoglobin concentration through a capillary blood test.

.

Being tested
Dietary Counseling
Keywords
complementary feeding, added sugar, ultra-processed foods, intervention, infants
Medical subject headings
Infant Nutrition Disorders, Feeding Behavior, Behavior

What participants receive

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

  • Dietary CounselingOther

    The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the "Ten Steps of Healthy Feeding for children from Birth to Two years of life". The research team will focus on Step2: "Do not give added sugar or foods with added sugar", and Step8:"Do not offer ultra-processed foods as candies and soft drinks". To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months.

Study groups in NCT03841123
Study groupRoleWhat they receive
InterventionExperimentalAt the maternity wards mothers will receive dietary counseling and leaflets as a reminder to prevent the early introduction of added sugar and ultra-processed foods.
Receives: Other: Dietary Counseling
ControlNo interventionAt the maternity wards mothers assigned to control groups will have all the health assistance related to the maternity routine without any interference from the study protocol.

What is being measured

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

  1. Amount of Added Sugar and ultra-processed foods consumed at 6 months

    Information will be obtained through two not consecutive dietary 24 hour recall

    Measured: 6 months

  2. Amount of Added Sugar and ultra-processed foods consumed at 12 months

    Information will be obtained through two not consecutive dietary 24 hour recall

    Measured: 12 months

  3. weight gain pattern at 6 months

    Weight at birth and six months will be obtained and the weight gain velocity will be calculated

    Measured: 6 months

  4. weight gain pattern at 12 months

    Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated

    Measured: 12 months.

  5. Number of Participants with dental caries

    The dental examination will be performed by dentists

    Measured: 12 months

  6. Anemia prevalence

    The hemoglobin levels will be obtained by capillary blood tests

    Measured: 12 months

  7. Exclusive breastfeeding duration

    Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding

    Measured: 6 months

  8. Prevalence of continued breastfeeding at 1 year

    Proportion of children 12 months of age who are breastfed

    Measured: 12 months

Secondary outcomes (5)

  1. Minimally processed foods, processed foods and total energy intake consumed at 6 months

    Information will be obtained through two not consecutive dietary 24 hour recall

    Measured: 6 months

  2. Minimally processed foods, processed foods and total energy intake consumed at 12 months

    Information will be obtained through two not consecutive dietary 24 hour recall

    Measured: 12 months

  3. Offer of added sugar and ultra-processed foods at 6 months

    Information will be obtained through a food introduction questionnaire

    Measured: 6 months

  4. Offer of added sugar and ultra-processed foods at 12 months

    Information will be obtained through a food introduction questionnaire

    Measured: 12 months

  5. Proportion of infants from 0-12 months of age who are fed with infant formula, cow's milk and toddler milk

    Information will be obtained through a food introduction questionnaire

    Measured: 12 months

Timeline

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

  1. First posted15 Feb 2019
  2. Study start10 Sep 2018
  3. Primary completion31 Dec 2018
  4. Study completion25 Feb 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
516 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03841123
Sponsor's protocol ID
UFCSPA-RS
Status last verified
Mar 2024
First submitted
18 Dec 2018
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Under Discussion

Publications

  • Feldens CA, Konzen BAS, de Barros Coelho EMR, Alves AC, Feldens EG, Vitolo MR, Kramer PF. Traumatic dental injuries in the first year of life and related risk factors in three regions of Brazil: a multicenter birth cohort study. BMC Oral Health. 2025 Jan 22;25(1):116. doi: 10.1186/s12903-025-05519-z.

    PubMed 39844120

  • Feldens CA, de Barros Coelho EMR, Vitolo MR, Rogrigues PH, Kramer PF, Peres KG. Effectiveness of a Sugar Consumption Prevention Program in the First Year of Life on the Occurrence of Early Childhood Caries: A Multicentric Randomized Trial in Brazil. Caries Res. 2025;59(3):174-184. doi: 10.1159/000541028. Epub 2024 Oct 30.

    PubMed 39476808

  • Feldens CA, Heck ABDS, Rodrigues PH, Coelho EMRB, Vitolo MR, Kramer PF. Ankyloglossia and Breastfeeding Duration: A Multicenter Birth Cohort Study. Breastfeed Med. 2024 Jan;19(1):17-25. doi: 10.1089/bfm.2023.0182.

    PubMed 38241126

Questions about this trial

What is this clinical trial studying?

A study testing Dietary Counseling in people with Infant Nutrition Disorders and Feeding Patterns, 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 3 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 13 Mar 2024. 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?

Amount of Added Sugar and ultra-processed foods consumed at 6 months (time frame: 6 months). The study lists 8 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 NCT03841123, which also lists 3 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 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in