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
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
126
Hasanuddin University Medical Research Center / HUMRC
Makassar, South Sulawesi, Indonesia
RECRUITINGInfant weight
This includes weight at birth, weight at 3 months and 6 months
Time frame: changes of weight at birth up to 6 months
Infant Length
This includes length of body at birth, at 3 months and 6 months
Time frame: changes of length at birth up to 6 months
Hemoglobin level of mother
Hemoglobin level of mother measured in blood using hematology analyzer
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: changes of TGF Beta 1 level of infant from the day of birth to 6 months
Halisah Halisah, M.Keb
CONTACT
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