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

Not Applicable

Completed

• Conditions: Feeding Patterns; Health Knowledge, Attitudes, Practice; Infant Nutrition Disorders
• Interventions: Other: Dietary Counseling

• Registration Number: NCT03841123
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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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Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2018-12-18
• Primary Completion: 2018-12-31
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Completion: 2020-02-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dietary Counseling	At 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with dental caries	12 months	The dental examination will be performed by dentists
Exclusive breastfeeding duration	6 months	Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding
weight gain pattern at 6 months	6 months	Weight at birth and six months will be obtained and the weight gain velocity will be calculated
Anemia prevalence	12 months	The hemoglobin levels will be obtained by capillary blood tests
Amount of Added Sugar and ultra-processed foods consumed at 6 months	6 months	Information will be obtained through two not consecutive dietary 24 hour recall
Amount of Added Sugar and ultra-processed foods consumed at 12 months	12 months	Information will be obtained through two not consecutive dietary 24 hour recall
weight gain pattern at 12 months	12 months.	Weight at six months and 12 months will be obtained and the weight gain velocity will be calculated
Prevalence of continued breastfeeding at 1 year	12 months	Proportion of children 12 months of age who are breastfed

Secondary Outcome Measures

Name	Time	Method
Offer of added sugar and ultra-processed foods at 6 months	6 months	Information 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 milk	12 months	Information will be obtained through a food introduction questionnaire
Minimally processed foods, processed foods and total energy intake consumed at 12 months	12 months	Information will be obtained through two not consecutive dietary 24 hour recall
Offer of added sugar and ultra-processed foods at 12 months	12 months	Information will be obtained through a food introduction questionnaire
Minimally processed foods, processed foods and total energy intake consumed at 6 months	6 months	Information will be obtained through two not consecutive dietary 24 hour recall

Trial Locations

Locations (1)

Federal University of Health Science of Porto Alegre; 🇧🇷 Porto Alegre, Centro Histórico, Brazil