Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT05100550
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-based Health Education Program and Zinc Supplementation for Stunted Mother
Sponsor:
Hasanuddin University
Organization:
Study Overview
Official Title:
Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: