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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05100550
Enrollment
126
Registered
2021-10-29
Start date
2020-09-01
Completion date
2021-12-01
Last updated
2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal-Fetal Relations, Stunting

Keywords

Insulin-like Growth Factor 1, Zinc, Hemoglobin, Health Education, Stunting, Low-income Family

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

Interventions

DIETARY_SUPPLEMENTZinc

Zinc is given as written in the arm description, two hours after lunch

OTHERControl

This group will not receive zinc

Sponsors

Hasanuddin University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Body height is less than 150 cm 2. Upper Arm Circumference less than 23.5 cm 3. Family income is less than Rp 2,500,000,- following the minimum wage of targeted area 4. 24-26 weeks pregnant.

Exclusion criteria

1. has pregnancy complications 2. multiple infants 3. refuse to follow the protocol

Design outcomes

Primary

MeasureTime frameDescription
Infant weightchanges of weight at birth up to 6 monthsThis includes weight at birth, weight at 3 months and 6 months
Infant Lengthchanges of length at birth up to 6 monthsThis includes length of body at birth, at 3 months and 6 months

Secondary

MeasureTime frameDescription
Zinc level of mother in breast milkchanges of Zinc in breast milk of mother from the delivery day to 6 months after deliveryZinc level of mother measured in blood using atomic absorption spectrometric
Hemoglobin level of infantchanges of hemoglobin level of infant from the day of birth to 6 monthsHemoglobin level of infant measured in blood using hematology analyzer
Insulin-like growth factor 1 (IGF-1) of motherchanges of IGF-1 level of mother from the baseline to day of deliveryInsulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Hemoglobin level of motherchanges of hemoglobin level of mother from the baseline to delivery timeHemoglobin level of mother measured in blood using hematology analyzer
Brain-derived neurotrophic Factor (BDNF) of infantchanges of BDNF level of infant from the day of birth to 6 monthsBrain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
Tumor Growth Factor Beta 1 (TGF beta 1) of infantchanges of TGF Beta 1 level of infant from the day of birth to 6 monthsTumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
Insulin-like growth factor 1 (IGF-1) of infantchanges of IGF-1 level of infant from the day of birth to 6 monthsInsulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Zinc level of mother in bloodchanges of Zinc in blood of mother from the baseline to 6 months after deliveryZinc level of mother measured in blood using hematology analyzer

Countries

Indonesia

Contacts

Primary ContactHalisah Halisah, M.Keb
armiyatinur@gmail.com+6285341247477
Backup ContactHalisah Halisah, M.Keb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026