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 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
50
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Anggi Yosefin Pratiwi Butar Butar
- Telefonnummer: +6281362419458
- E-post: anggiyosefin@gmail.com
Studieorter
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North Sumatera
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Medan, North Sumatera, Indonesien
- Nutrition Departement, Universitas Sumatera Utara, Medan, Indonesia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in Maternal Energy and Nutrient Intake
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
31 oktober 2026
Studieregistreringsdatum
Först inskickad
16 juli 2026
Först inskickad som uppfyllde QC-kriterierna
16 juli 2026
Första postat (Faktisk)
21 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- USU Maternity Nutrition
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