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 julio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Anggi Yosefin Pratiwi Butar Butar
- Número de teléfono: +6281362419458
- Correo electrónico: anggiyosefin@gmail.com
Ubicaciones de estudio
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North Sumatera
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Medan, North Sumatera, Indonesia
- Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Maternal Energy and Nutrient Intake
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
30 de septiembre de 2026
Finalización del estudio (Estimado)
31 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
16 de julio de 2026
Publicado por primera vez (Actual)
21 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- USU Maternity Nutrition
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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