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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
| Federal University of Bahia | OTHER |
| Federal University of Amazonas | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Minimally processed foods, processed foods and total energy intake consumed at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcia R Vitolo, PhD | Federal University of Health Science of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Health Science of Porto Alegre | Porto Alegre | Centro Histórico | 90050-170 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39844120 | Derived | Feldens CA, Konzen BAS, de Barros Coelho EMR, Alves AC, Feldens EG, Vitolo MR, Kramer PF. Traumatic dental injuries in the first year of life and related risk factors in three regions of Brazil: a multicenter birth cohort study. BMC Oral Health. 2025 Jan 22;25(1):116. doi: 10.1186/s12903-025-05519-z. | |
| 39476808 | Derived |
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Under Discussion
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|
Proportion of children 12 months of age who are breastfed
| 12 months |
Information will be obtained through two not consecutive dietary 24 hour recall |
| 12 months |
| Offer of added sugar and ultra-processed foods at 6 months | Information will be obtained through a food introduction questionnaire | 6 months |
| Offer of added sugar and ultra-processed foods at 12 months | Information will be obtained through a food introduction questionnaire | 12 months |
| 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 |
| 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. |
| 38241126 | 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. |
| ID | Term |
|---|---|
| D007228 | Infant Nutrition Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001522 | Behavior, Animal |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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