Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT05100550
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
Study:
NCT05100550
Study Brief:
Protocol Section:
NCT05100550