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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03841123
Enrollment
516
Registered
2019-02-15
Start date
2018-09-10
Completion date
2020-02-25
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Patterns, Health Knowledge, Attitudes, Practice, Infant Nutrition Disorders

Keywords

complementary feeding, added sugar, ultra-processed foods, intervention, infants

Brief 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.

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. .

Interventions

OTHERDietary Counseling

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.

Sponsors

Ministry of Health, Brazil
CollaboratorOTHER_GOV
Federal University of Bahia
CollaboratorOTHER
Federal University of Amazonas
CollaboratorOTHER
Federal University of Health Science of Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Hours to 72 Hours
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of continued breastfeeding at 1 year12 monthsProportion of children 12 months of age who are breastfed
weight gain pattern at 6 months6 monthsWeight at birth and six months will be obtained and the weight gain velocity will be calculated
weight gain pattern at 12 months12 months.Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
Number of Participants with dental caries12 monthsThe dental examination will be performed by dentists
Anemia prevalence12 monthsThe hemoglobin levels will be obtained by capillary blood tests
Exclusive breastfeeding duration6 monthsProportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
Amount of Added Sugar and ultra-processed foods consumed at 6 months6 monthsInformation will be obtained through two not consecutive dietary 24 hour recall
Amount of Added Sugar and ultra-processed foods consumed at 12 months12 monthsInformation will be obtained through two not consecutive dietary 24 hour recall

Secondary

MeasureTime frameDescription
Minimally processed foods, processed foods and total energy intake consumed at 12 months12 monthsInformation will be obtained through two not consecutive dietary 24 hour recall
Offer of added sugar and ultra-processed foods at 6 months6 monthsInformation will be obtained through a food introduction questionnaire
Offer of added sugar and ultra-processed foods at 12 months12 monthsInformation will be obtained through a food introduction questionnaire
Proportion of infants from 0-12 months of age who are fed with infant formula, cow's milk and toddler milk12 monthsInformation will be obtained through a food introduction questionnaire
Minimally processed foods, processed foods and total energy intake consumed at 6 months6 monthsInformation will be obtained through two not consecutive dietary 24 hour recall

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026