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

Study Overview
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Brief Summary
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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 : To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother 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
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Details of Family-Based Health Education Program + Zinc : Home-visit and health promotion by trained midwives Supervision by health volunteer Zinc Supplementation General target population : Stunted pregnant mother on the third trimester of pregnancy 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 : Sociodemographic information Food recall using Food Frequency Questionnaire List of outcomes Zinc level in breastmilk and blood of mother and infant Insulin-like growth factor 1 (IGF-1) level of mother and infant Hemoglobin level of mother and infant Infant and placental anthropometry Tumor growth Factor Beta 1 (TGF beta 1) in infant 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 Type 1 error 5% Effect size: 0.4486 Power of study: 80% With the equal allocation ratio, the total sample needed is 126 Proposed statistical analysis Independent T-test Linear Mixed Model

Official Title
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Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby

Conditions
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Stunting, Maternal-Fetal Relations

Intervention / Treatment
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* Dietary Supplement: Zinc
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Body height is less than 150 cm Upper Arm Circumference less than 23.5 cm Family income is less than Rp 2,500,000,- following the minimum wage of targeted area 24-26 weeks pregnant. Exclusion Criteria has pregnancy complications multiple infants refuse to follow the protocol

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will receive Health education regarding nutrition in pregnancy (including the importance of micronutrients, recognizing malnutrition, practicing breastfeeding) Screening of Low birth weight risk Zinc Supplementation 20 mg/daily from gestation week for 12 weeks, followed by 12 weeks of supplementation on the third day postpartum. | Dietary Supplement: Zinc<br>* Zinc is given as written in the arm description, two hours after lunch<br>|
| Active Comparator: Control<br>Standard antenatal care for third trimester will be applied without supplementation of zinc | Other: Control<br>* This group will not receive zinc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant weight | This includes weight at birth, weight at 3 months and 6 months | changes of weight at birth up to 6 months | 
| Infant Length | This includes length of body at birth, at 3 months and 6 months | changes of length at birth up to 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin-like Growth Factor 1, Zinc, Hemoglobin, Health Education, Stunting, Low-income Family