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 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Anggi Yosefin Pratiwi Butar Butar
- Numéro de téléphone: +6281362419458
- E-mail: anggiyosefin@gmail.com
Lieux d'étude
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North Sumatera
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Medan, North Sumatera, Indonésie
- Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Maternal Energy and Nutrient Intake
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
30 septembre 2026
Achèvement de l'étude (Estimé)
31 octobre 2026
Dates d'inscription aux études
Première soumission
16 juillet 2026
Première soumission répondant aux critères de contrôle qualité
16 juillet 2026
Première publication (Réel)
21 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- USU Maternity Nutrition
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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