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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Unknown NA INTERVENTIONAL NCT05100550

Family-based Health Education Program and Zinc Supplementation for Stunted Mother

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Background : It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Zinc has been associated with better neonatal growth and brain growth. This study aims to assess the impact of family-based health education programs plus zinc supplementation on the important biomarker of pregnancy and neonatal growth. Objective : 1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother 2. 1\. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother Methodology : A Quasi-experimental study involving stunted pregnant mother with parallel intervention Hypothesis : Mother who receives the intervention will have the better maternal and neonatal outcome

Detailed Description

Details of Family-Based Health Education Program + Zinc : 1. Home-visit and health promotion by trained midwives 2. Supervision by health volunteer 3. Zinc Supplementation General target population : 1. Stunted pregnant mother on the third trimester of pregnancy 2. Conducted in Primary Health Care Center Design of Study : two arms quasi-experimental study with one group receiving the intervention and comparison receiving standard Antenatal Care. The baseline measurement is conducted at the beginning of the third trimester, followed by the day of delivery and 6 months after delivery (for assessing the outcome of the infant). Participants are matched by certain variables Variable : 1. Sociodemographic information 2. Food recall using Food Frequency Questionnaire List of outcomes 1. Zinc level in breastmilk and blood of mother and infant 2. Insulin-like growth factor 1 (IGF-1) level of mother and infant 3. Hemoglobin level of mother and infant 4. Infant and placental anthropometry 5. Tumor growth Factor Beta 1 (TGF beta 1) in infant 6. Brain-derived neurotrophic factor (BDNF) in infant Sample size using the difference between two means of neonatal birth weight who received zinc and did not receive zinc according to a study in Iran 1. Type 1 error 5% 2. Effect size: 0.4486 3. Power of study: 80% 4. With the equal allocation ratio, the total sample needed is 126 Proposed statistical analysis 1. Independent T-test 2. Linear Mixed Model

Interventions

Name: Zinc
Type: DIETARY_SUPPLEMENT
Description: Zinc is given as written in the arm description, two hours after lunch
Name: Control
Type: OTHER
Description: This group will not receive zinc

Primary Outcomes

Measure: Infant weight
TimeFrame: changes of weight at birth up to 6 months
Description: This includes weight at birth, weight at 3 months and 6 months
Measure: Infant Length
TimeFrame: changes of length at birth up to 6 months
Description: This includes length of body at birth, at 3 months and 6 months

Trial Information

NCT ID

NCT05100550

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Hasanuddin University

Last Updated

December 15, 2025