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

Study Overview
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Brief Summary
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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
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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. .

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

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

Intervention / Treatment
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* Other: Dietary Counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 72 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complementary feeding, added sugar, ultra-processed foods, intervention, infants