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

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

Effectiveness of a Dietary Counseling to Prevent Added Sugar and Ultra-processed Foods During the First Year of Life: a Randomized Field Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841123
• Other study ID #: UFCSPA-RS
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: March 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: February 25, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Hour to 72 Hours

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Federal University of Health Science of Porto Alegre	Porto Alegre	Centro Histórico

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre	Federal University of Amazonas, Federal University of Bahia, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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.
Primary	Number of Participants with dental caries	The dental examination will be performed by dentists	12 months
Primary	Anemia prevalence	The hemoglobin levels will be obtained by capillary blood tests	12 months
Primary	Exclusive breastfeeding duration	Proportion of infants from 0-6 months at age who are fed exclusively with breastfeeding	6 months
Primary	Prevalence of continued breastfeeding at 1 year	Proportion of children 12 months of age who are breastfed	12 months
Secondary	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
Secondary	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
Secondary	Offer of added sugar and ultra-processed foods at 6 months	Information will be obtained through a food introduction questionnaire	6 months
Secondary	Offer of added sugar and ultra-processed foods at 12 months	Information will be obtained through a food introduction questionnaire	12 months
Secondary	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