The Effects of Structured Lactation Nutrition Education and Dali ni Horbo Supplementation on Maternal Nutritional Intake, Breastfeeding Practices, Infant Growth, and Gut Microbiota: A Randomized Controlled Trial
16 de julho de 2026 atualizado por: DINA KEUMALA SARI
This randomized controlled trial aims to evaluate the effects of structured lactation nutrition education combined with Dali ni Horbo supplementation on maternal dietary intake, breastfeeding practices, infant growth, and infant gut microbiota.
Lactating mothers with healthy infants aged 0-1 month will be recruited from selected primary healthcare centers in Medan, Indonesia, and assigned to an intervention or control group.
The intervention group will receive structured nutrition education and daily Dali ni Horbo, a traditional Batak fermented buffalo milk product, while the control group will receive standard care.
Maternal energy and nutrient intake, nutritional knowledge and attitudes, exclusive breastfeeding practices, maternal and infant anthropometric measurements, intervention adherence, adverse effects, and infant fecal microbiota composition will be assessed before and after the intervention.
This study is expected to determine whether integrating nutrition education with a nutrient-dense local food can improve maternal nutritional adequacy, support exclusive breastfeeding, promote optimal infant growth, and beneficially influence early-life gut microbiota.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Anggi Yosefin Pratiwi Butar Butar
- Número de telefone: +6281362419458
- E-mail: anggiyosefin@gmail.com
Locais de estudo
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North Sumatera
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Medan, North Sumatera, Indonésia
- Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Lactating mothers aged 18-40 years.
- Having a healthy, singleton infant aged 0-1 month at enrollment.
- Residing within the service areas of the participating primary healthcare centers in Medan, Indonesia.
- Currently breastfeeding and intending to continue breastfeeding throughout the study period.
- Able to consume Dali ni Horbo and willing to follow the assigned intervention.
- Willing to participate in all study assessments, including dietary assessment, anthropometric measurements, and infant stool collection.
- Able to communicate effectively and complete the study questionnaires.
- Willing to provide written informed consent.
Exclusion Criteria:
- Mothers or infants with medical conditions that may significantly affect breastfeeding, maternal nutritional status, nutrient metabolism, or infant growth.
- Mothers with severe postpartum complications or conditions requiring hospitalization.
- Infants with congenital abnormalities, gastrointestinal disorders, metabolic diseases, severe infections, or other conditions affecting feeding or growth.
- Infants born preterm or with low birth weight, according to the study protocol.
- Mothers with a known allergy or intolerance to buffalo milk, cow's milk, or dairy products.
- Mothers following a medically prescribed restrictive diet that could affect the study outcomes.
- Current participation in another nutritional or clinical intervention study.
- Use of nutritional supplements, probiotics, antibiotics, or other treatments that may substantially affect maternal nutrient intake or infant gut microbiota, unless permitted by the study protocol.
- Inability or unwillingness to comply with the intervention and follow-up procedures.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: experimental: Dali ni Horbo 100g/day
The intervention consists of daily supplementation with Dali ni Horbo, a traditional Batak food made from coagulated buffalo milk, provided to lactating mothers in a standardized portion throughout the study period.
The product is intended to increase maternal energy, protein, fat, calcium, and other nutrient intake during lactation.
Participants will receive instructions on the amount, timing, storage, and consumption of the product.
Adherence will be monitored through daily records and regular interviews, while gastrointestinal complaints, intolerance, or other adverse effects will also be documented.
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Participants will receive structured lactation nutrition education delivered by trained nutritionists according to a standardized educational protocol, together with daily supplementation of Dali ni Horbo, a traditional Batak coagulated buffalo milk product, throughout the intervention period.
The education focuses on balanced nutrition during lactation, adequate energy and nutrient intake, hydration, food diversity, and breastfeeding practices.
Dali ni Horbo will be provided in standardized daily portions, and participants will receive instructions regarding its consumption, storage, and handling.
Adherence and any adverse events will be monitored throughout the study.
Participants will receive routine maternal and child healthcare services provided at the participating primary healthcare centers, including standard postpartum and breastfeeding counseling according to local practice, without structured lactation nutrition education or Dali ni Horbo supplementation.
Participants will continue their usual diet and breastfeeding practices throughout the study period and will undergo the same outcome assessments as the intervention group.
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Outro: control group
Participants in the control group will receive standard maternal and child healthcare services routinely provided at the participating primary healthcare centers, without Dali ni Horbo supplementation.
They will continue their usual diet and breastfeeding practices throughout the study period.
Maternal dietary intake, breastfeeding practices, nutritional status, infant growth, and infant gut microbiota will be assessed using the same schedule and methods as in the intervention group.
Any additional nutritional supplements or relevant dietary changes during the study will be recorded.
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Participants will receive routine maternal and child healthcare services provided at the participating primary healthcare centers, including standard postpartum and breastfeeding counseling according to local practice, without structured lactation nutrition education or Dali ni Horbo supplementation.
Participants will continue their usual diet and breastfeeding practices throughout the study period and will undergo the same outcome assessments as the intervention group.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Maternal Energy and Nutrient Intake
Prazo: baseline and 4 weeks
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Change in maternal dietary intake from baseline to the end of the intervention, assessed using 24-hour dietary recalls and analyzed for daily energy, protein, fat, carbohydrate, and calcium intake.
Nutrient intake will be compared between the intervention and control groups to evaluate the effectiveness of structured lactation nutrition education combined with Dali ni Horbo supplementation.
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baseline and 4 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de agosto de 2026
Conclusão Primária (Estimado)
30 de setembro de 2026
Conclusão do estudo (Estimado)
31 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
16 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de julho de 2026
Primeira postagem (Real)
21 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
21 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- USU Maternity Nutrition
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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