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

Обзор

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.

Вмешательства

• Пищевая добавка Dali ni Horbo Supplementation
  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 dai
• Другое Standard Maternal Care
  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.

Первичные конечные точки

• Change in Maternal Energy and Nutrient Intake [Срок оценки: baseline and 4 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Индонезия · 1 центр

• Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia — Medan

Идентификаторы

NCT: NCT07718087 · USU Maternity Nutrition

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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