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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorDINA KEUMALA SARI

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dali ni Horbo Supplementation

    Dietary supplement

    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.

  • Standard Maternal Care

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: experimental: Dali ni Horbo 100g/dayExperimental treatment 2 interventions
Group B: control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in Maternal Energy and Nutrient Intake

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.

Time frame
baseline and 4 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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DINA KEUMALA SARI

Lead sponsor

Universitas Sumatera Utara

Sponsor institution

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