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

Hasanuddin University

Status: Unknown

Conditions: Maternal-Fetal Relations; Stunting

Treatments: Other: Control; Dietary Supplement: Zinc

Study type: Interventional

Funder types: Other

Identifiers

NCT05100550

2209210954

Details and patient eligibility

About

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

Full 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

Enrollment: 126 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Zinc

Control

Active Comparator group

Description:

Standard antenatal care for third trimester will be applied without supplementation of zinc

Treatment:

Other: Control