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

Stunting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100550
• Other study ID #: 2209210954
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: October 2021
• Source: Hasanuddin University
• Contact: Halisah Halisah, M.Keb
• Phone: +6285341247477
• Email: armiyatinur[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 1, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders
• Maternal-Fetal Relations
• Stunting

Intervention

Dietary Supplement:
• Zinc
Zinc is given as written in the arm description, two hours after lunch

Other:
• Control
This group will not receive zinc

Locations

Country	Name	City	State
Indonesia	Hasanuddin University Medical Research Center / HUMRC	Makasar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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). pii: E641. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant weight	This includes weight at birth, weight at 3 months and 6 months	changes of weight at birth up to 6 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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