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

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

Study Overview

• Status: Recruiting
• Conditions: Maternal-Fetal Relations; Stunting
• Intervention / Treatment: Dietary supplement: Zinc; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Halisah Halisah, M.Keb; Phone Number: +6285341247477; Email: armiyatinur@gmail.com
• Study Contact Backup: Name: Halisah Halisah, M.Keb

Study Locations

• Indonesia
  • South Sulawesi
    • Makasar, South Sulawesi, Indonesia, 90245
      • Recruiting
      • Hasanuddin University Medical Research Center / HUMRC
      • Contact: Bumi Herman, M.D, Ph.D; Email: bumiherman@med.unhas.ac.id
      • Principal Investigator: Bumi Herman, M.D Ph.D
      • Principal Investigator: Firman Hasan, M.D
      • Principal Investigator: Karina Patricia, M.D
      • Principal Investigator: Muthiah Abustani, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Zinc is given as written in the arm description, two hours after lunch
Active Comparator: Control; Standard antenatal care for third trimester will be applied without supplementation of zinc	Other: Control; This group will not receive zinc

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Investigators: Principal Investigator: Agussalim Bukhari, MD.Ph.D, Hasanuddin University; Principal Investigator: Nurpudji A Taslim, Prof, Hasanuddin University; Principal Investigator: Aidah Baso, MD. Ph.D, Hasanuddin University; Principal Investigator: Sitti MT Chalid, MD. Ph.D, Hasanuddin University; Principal Investigator: Kadek Erika, RN, Hasanuddin University; Principal Investigator: Nasrudin Mappaware, MD, Muslim University Indonesia; Principal Investigator: Mardiana Ahmad, MD, Hasanuddin University; Principal Investigator: Suryani As'ad, Prof, Hasanuddin University; Principal Investigator: Rosdiana Natsir, Prof, Hasanuddin University; Principal Investigator: Martira Maddepungeng, MD, Hasanuddin University; Principal Investigator: Rian Pamungkas, RN, Ph.D, Esa Unggul University; Principal Investigator: Halisah Wahyuningsih, MW., Hasanuddin University; Principal Investigator: Wahyuningsih Wahyuningsih, RN, Hasanuddin University; Principal Investigator: Armiyati Nur, MW, Hasanuddin University

Publications and helpful links

General Publications

• Boskabadi H, Maamouri G, Akhondian J, Ashrafzadeh F, Boskabadi A, Faramarzi R, Heidar E, Pourbadakhshan N, Shojaei SRH, Zakerihamidi M, Vatanchi AM, Sokhtanloo M, Razaghi N, Kalani F, Ataei H, Darabi A, Mousavi MS, Hakimiakhangan S, Bagheri F. Comparison of birth weights of neonates of mothers receiving vs. not receiving zinc supplement at pregnancy. BMC Pregnancy Childbirth. 2021 Mar 6;21(1):187. doi: 10.1186/s12884-021-03598-8.
• Wilson RL, Grieger JA, Bianco-Miotto T, Roberts CT. Association between Maternal Zinc Status, Dietary Zinc Intake and Pregnancy Complications: A Systematic Review. Nutrients. 2016 Oct 15;8(10):641. doi: 10.3390/nu8100641.
• Prata N, Tavrow P, Upadhyay U. Women's empowerment related to pregnancy and childbirth: introduction to special issue. BMC Pregnancy Childbirth. 2017 Nov 8;17(Suppl 2):352. doi: 10.1186/s12884-017-1490-6. No abstract available.
• Finch CW. Review of trace mineral requirements for preterm infants: what are the current recommendations for clinical practice? Nutr Clin Pract. 2015 Feb;30(1):44-58. doi: 10.1177/0884533614563353. Epub 2014 Dec 19.
• Zahiri Sorouri Z, Sadeghi H, Pourmarzi D. The effect of zinc supplementation on pregnancy outcome: a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(13):2194-8. doi: 10.3109/14767058.2015.1079615. Epub 2015 Sep 12.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): November 15, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Hemoglobin; Health Education; Zinc; Stunting; Insulin-like Growth Factor 1; Low-income Family
• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: 2209210954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Deidentified data will be shared accordingly

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No