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

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice; Feeding Patterns; Infant Nutrition Disorders
• Intervention / Treatment: Other: Dietary Counseling

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.

.

• Study Type: Interventional
• Enrollment (Actual): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Centro Histórico
    • Porto Alegre, Centro Histórico, Brazil, 90050-170
      • Federal University of Health Science of Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 3 days (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Dietary 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.
No Intervention: Control; At 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 the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months
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	12 months
Offer of added sugar and ultra-processed foods at 6 months	Information will be obtained through a food introduction questionnaire	6 months
Offer of added sugar and ultra-processed foods at 12 months	Information will be obtained through a food introduction questionnaire	12 months
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	12 months

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre
• Collaborators: Ministry of Health, Brazil; Federal University of Bahia; Federal University of Amazonas
• Investigators: Principal Investigator: Marcia R Vitolo, PhD, Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: infants; intervention; complementary feeding; added sugar; ultra-processed foods
• Additional Relevant MeSH Terms: Nutrition Disorders; Infant Nutrition Disorders
• Other Study ID Numbers: UFCSPA-RS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Under Discussion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No