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

NCT ID: NCT03841123

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 516 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2020-02-25

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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Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary Counseling

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Federal University of Bahia

OTHER

Sponsor Role: collaborator

Federal University of Amazonas

OTHER

Sponsor Role: collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Marcia Regina Vitolo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcia R Vitolo, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Science of Porto Alegre

Locations

Federal University of Health Science of Porto Alegre

Porto Alegre, Centro Histórico, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 39476808 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38241126 (View on PubMed)

Other Identifiers

UFCSPA-RS

Identifier Type: -

Identifier Source: org_study_id