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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Maternal Energy and Nutrient Intake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Maternal Energy and Nutrient Intake
时间窗: baseline and 4 weeks
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.
次要结局
未报告次要终点
研究者
DINA KEUMALA SARI
Prof
Universitas Sumatera Utara