Clinical Trials Directory

Trials / Completed

CompletedNCT03841123

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
516 (actual)
Sponsor
Federal University of Health Science of Porto Alegre · Academic / Other
Sex
All
Age
1 Hour – 72 Hours
Healthy volunteers
Accepted

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. .

Conditions

Interventions

TypeNameDescription
OTHERDietary CounselingThe 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.

Timeline

Start date
2018-09-10
Primary completion
2018-12-31
Completion
2020-02-25
First posted
2019-02-15
Last updated
2024-03-13

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT03841123. Inclusion in this directory is not an endorsement.