Clinical trial NCT03841123: Effectiveness of a Dietary Counseling to Prevent Early Consumption of Added Sugar and Ultra-processed Foods
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Nutrition Disorders
Feeding Patterns
Health Knowledge, Attitudes, Practice
Keywords: complementary feeding
added sugar
ultra-processed foods
intervention
infants
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
name: Federal University of Bahia
name: Federal University of Amazonas
First posted: 2019-02-15
Enrollment: 516
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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Eligibility criteria: 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.

Primary outcomes:
measure: Amount of Added Sugar and ultra-processed foods consumed at 6 months
timeFrame: 6 months
measure: Amount of Added Sugar and ultra-processed foods consumed at 12 months
timeFrame: 12 months
measure: weight gain pattern at 6 months
timeFrame: 6 months
measure: weight gain pattern at 12 months
timeFrame: 12 months.
measure: Number of Participants with dental caries
timeFrame: 12 months
measure: Anemia prevalence
timeFrame: 12 months
measure: Exclusive breastfeeding duration
timeFrame: 6 months
measure: Prevalence of continued breastfeeding at 1 year
timeFrame: 12 months
Secondary outcomes:
measure: Minimally processed foods, processed foods and total energy intake consumed at 6 months
timeFrame: 6 months
measure: Minimally processed foods, processed foods and total energy intake consumed at 12 months
timeFrame: 12 months
measure: Offer of added sugar and ultra-processed foods at 6 months
timeFrame: 6 months
measure: Offer of added sugar and ultra-processed foods at 12 months
timeFrame: 12 months
measure: Proportion of infants from 0-12 months of age who are fed with infant formula, cow's milk and toddler milk
timeFrame: 12 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Science of Porto Alegre
state: Centro Histórico
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Marcia R Vitolo, PhD
role: PRINCIPAL_INVESTIGATOR
References: