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NCT07718087

Overview

NCT ID: NCT07718087
Lead Sponsor: DINA KEUMALA SARIOTHER
Official Title: 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
Brief Summary: 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 50Estimated
Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Anggi Yosefin Pratiwi Butar ButarContact
anggiyosefin@gmail.com+6281362419458

Similar Studies

Participant Group/Arms

experimental: Dali ni Horbo 100g/dayExperimental

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.

Dietary Supplement: Dali ni Horbo Supplementation

Other: Standard Maternal Care

control groupOther

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.

Other: Standard Maternal Care