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

Not Applicable

• Conditions: Maternal-Fetal Relations; Stunting
• Interventions: Other: Control; Dietary Supplement: Zinc

• Registration Number: NCT05100550
• Lead Sponsor: Hasanuddin University

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 Timeline

• Study Start: 2020-09-01
• Status Verified: 2021-10
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Standard antenatal care for third trimester will be applied without supplementation of zinc
Intervention	Zinc	This group will receive 1. Health education regarding nutrition in pregnancy (including the importance of micronutrients, recognizing malnutrition, practicing breastfeeding) 2. Screening of Low birth weight risk 3. Zinc Supplementation 20 mg/daily from gestation week for 12 weeks, followed by 12 weeks of supplementation on the third day postpartum.

Primary Outcome Measures

Name	Time	Method
Infant weight	changes of weight at birth up to 6 months	This includes weight at birth, weight at 3 months and 6 months
Infant Length	changes of length at birth up to 6 months	This includes length of body at birth, at 3 months and 6 months

Secondary Outcome Measures

Name	Time	Method
Hemoglobin level of mother	changes of hemoglobin level of mother from the baseline to delivery time	Hemoglobin level of mother measured in blood using hematology analyzer
Insulin-like growth factor 1 (IGF-1) of infant	changes of IGF-1 level of infant from the day of birth to 6 months	Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Tumor Growth Factor Beta 1 (TGF beta 1) of infant	changes of TGF Beta 1 level of infant from the day of birth to 6 months	Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
Zinc level of mother in blood	changes of Zinc in blood of mother from the baseline to 6 months after delivery	Zinc level of mother measured in blood using hematology analyzer
Zinc level of mother in breast milk	changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery	Zinc level of mother measured in blood using atomic absorption spectrometric
Hemoglobin level of infant	changes of hemoglobin level of infant from the day of birth to 6 months	Hemoglobin level of infant measured in blood using hematology analyzer
Insulin-like growth factor 1 (IGF-1) of mother	changes of IGF-1 level of mother from the baseline to day of delivery	Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Brain-derived neurotrophic Factor (BDNF) of infant	changes of BDNF level of infant from the day of birth to 6 months	Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)

Trial Locations

Locations (1)

Hasanuddin University Medical Research Center / HUMRC; 🇮🇩 Makasar, South Sulawesi, Indonesia