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

NCT03841123 | Completed

• 1 other identifier: UFCSPA-RS
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (5)

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

  6 months

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

  12 months

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

  6 months

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

  12 months

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

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Dietary Counseling OTHER

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.

Intervention

Eligibility Criteria

• Age: 1 Hour - 72 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead
• Ministry of Health, Brazil: collaborator
• Federal University of Bahia: collaborator
• Federal University of Amazonas: collaborator

Study Sites (1)

Federal University of Health Science of Porto Alegre

Porto Alegre, Centro Histórico, 90050-170, Brazil

Location

Related Publications (2)

• 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.

  PMID: 39476808 DERIVED

• 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.

  PMID: 38241126 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders; Feeding Behavior; Behavior

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior, Animal

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marcia R Vitolo, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: February 15, 2019
• Study Start: September 10, 2018
• Primary Completion: December 31, 2018
• Study Completion: February 25, 2020
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

BR (1)