Public trial
RBR-8trmhd6 Educational intervention for pregnant women to delay the introduction of sugar and control the occurrence of caries in b...
Date of registration: 10/04/2026 (mm/dd/yyyy)Last approval date : 10/04/2026 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Educational intervention for pregnant women to delay the introduction of sugar and control the occurrence of caries during the child's first thousand days: a randomized clinical trial
pt-br
Intervenção educativa em gestantes para postergar a introdução do açúcar e controlar a ocorrência de cárie nos primeiros mil dias da criança: um ensaio clínico randomizado
es
Educational intervention for pregnant women to delay the introduction of sugar and control the occurrence of caries during the child's first thousand days: a randomized clinical trial
Trial identification
- UTN code: U1111-1346-6337
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Public title:
en
Educational intervention for pregnant women to delay the introduction of sugar and control the occurrence of caries in babies
pt-br
Intervenção educativa em gestantes para postergar a introdução do açúcar e controlar a ocorrência de cárie nos bebês
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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8.367.621
Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de Santa Maria
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96234026.7.0000.5346
Issuing authority: Plataforma Brasil
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8.367.621
Sponsors
- Primary sponsor: Universidade Federal de Santa Maria
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Secondary sponsor:
- Institution: Universidade Federal de Santa Maria
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Supporting source:
- Institution: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Health conditions
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Health conditions:
en
Cariogenic Diet
pt-br
Dieta cariogênica
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General descriptors for health conditions:
en
K02 Dental Caries
pt-br
K02 Cárie Dentária
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Specific descriptors:
en
G07.203.650.240.255 Cariogenic Diet
pt-br
G07.203.650.240.255 Dieta Cariogênica
Interventions
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Interventions:
en
This is a two-arm, blinded, randomized clinical trial conducted with pregnant women receiving prenatal and postpartum care at Basic Health Units (UBS) in the municipalities of Santa Rosa and Santa Maria, in the state of Rio Grande do Sul. Experimental group: 90 pregnant women will receive an educational video weekly for four weeks, addressing the harmful effects of the early introduction of sugars into the infant diet and the associated consequences regarding the development of obesity (week 1), diabetes mellitus (week 2), the establishment of dietary habits (week 3), and dental caries (week 4). Control group: 90 pregnant women who won't receive the videos
pt-br
Trata-se de um ensaio clínico randomizado, com dois braços, cego, conduzido com gestantes atendidas durante o pré-natal e o acompanhamento puerperal em Unidades Básicas de Saúde (UBS) do município de Santa Rosa e Santa Maria, no estado do Rio Grande do Sul. Grupo experimental: 90 gestantes receberão semanalmente por quatro semanas um vídeo educativo que abordará os malefícios da introdução precoce de açúcares na dieta infantil e suas repercussões no desenvolvimento de obesidade (semana 1), diabetes mellitus (semana 2), estabelecimento de preferências alimentares inadequadas (semana 3) e cárie dentária (semana 4). Grupo controle: 90 gestantes que não receberão os vídeos
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Descriptors:
en
N02.421.143.303 Counseling
pt-br
N02.421.143.303 Aconselhamento
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 09/03/2026 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 180 F 18 Y 0 -
Inclusion criteria:
en
Eligible participants will be pregnant women over the age of 18 who receive prenatal care at Basic Health Units (UBS) in Santa Rosa and Santa Maria; who are Brazilian or have Brazilian Portuguese as their native language; who have no visual or cognitive impairments preventing them from reading and/or comprehending; who possess smartphones with internet access and the WhatsApp Messenger® app; and who are between 12 and 30 weeks pregnant
pt-br
Serão consideradas elegíveis gestantes acima de 18 anos que realizam seu pré-natal nas unidades básicas de saúde (UBS) de Santa Rosa e Santa Maria, brasileiras, ou que tenham o português brasileiro como língua materna, sem alterações visuais ou cognitivas que as impossibilitem de ler e/ou compreender, que tiverem smartphones com acesso à internet e ao aplicativo WhatsApp Messenger®, e que estejam entre 12 e 30 semanas de gestação
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Exclusion criteria:
en
Participants who, for any reason, are unable to complete the assessments proposed in this study will be excluded
pt-br
Serão excluídas do estudo participantes que, por quaisquer razões, não possam cumprir com as avaliações propostas nesse estudo
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Prevention Parallel 2 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
It's expected to observe the introduction of sugar into the baby's diet at 6 months, 15 months, and 2 years of age
pt-br
Espera-se observar a introdução de açúcar na dieta do bebê aos 6 meses, 15 meses e 2 anos de vida
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Secondary outcomes:
en
It's expected to observe caries experience of children at 15 months and 2 years of age
pt-br
Espera-se observar a experiência de cárie das crianças aos 15 meses e aos 2 anos de idade
Data Sharing Plan
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Data Sharing Plan:
en
No
pt-br
No
es
No
Contacts
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Public contact
- Full name: Luana Severo Alves
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- Address: Roraima, 1000. Prédio 26F.
- City: Santa Maria / Brazil
- Zip code: 97015-900
- Phone: +55(55)3220-9281
- Email: luanaseal@gmail.com
- Affiliation: Universidade Federal de Santa Maria
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Scientific contact
- Full name: Luana Severo Alves
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- Address: Roraima, 1000. Prédio 26F.
- City: Santa Maria / Brazil
- Zip code: 97015-900
- Phone: +55(55)3220-9281
- Email: luanaseal@gmail.com
- Affiliation: Universidade Federal de Santa Maria
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Site contact
- Full name: Luana Severo Alves
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- Address: Roraima, 1000. Prédio 26F.
- City: Santa Maria / Brazil
- Zip code: 97015-900
- Phone: +55(55)3220-9281
- Email: luanaseal@gmail.com
- Affiliation: Universidade Federal de Santa Maria
Additional links:
Total de Ensaios Clínicos 19104.
Existem 9762 ensaios clínicos registrados.
Existem 5260 ensaios clínicos recrutando.
Existem 160 ensaios clínicos em análise.
Existem 6292 ensaios clínicos em rascunho.