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

• Sponsor: Hasanuddin University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05100550
• Collaborator: (none)
• Enrollment: 126
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stunting; Maternal-Fetal Relations	Dietary Supplement: Zinc; Other: Control	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Nov 15, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Infant weight [changes of weight at birth up to 6 months]

   This includes weight at birth, weight at 3 months and 6 months

2. Infant Length [changes of length at birth up to 6 months]

   This includes length of body at birth, at 3 months and 6 months

Secondary Outcome Measures

1. Hemoglobin level of mother [changes of hemoglobin level of mother from the baseline to delivery time]

   Hemoglobin level of mother measured in blood using hematology analyzer

2. Zinc level of mother in blood [changes of Zinc in blood of mother from the baseline to 6 months after delivery]

   Zinc level of mother measured in blood using hematology analyzer

3. Zinc level of mother in breast milk [changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery]

   Zinc level of mother measured in blood using atomic absorption spectrometric

4. Hemoglobin level of infant [changes of hemoglobin level of infant from the day of birth to 6 months]

   Hemoglobin level of infant measured in blood using hematology analyzer

5. Insulin-like growth factor 1 (IGF-1) of mother [changes of IGF-1 level of mother from the baseline to day of delivery]

   Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)

6. Insulin-like growth factor 1 (IGF-1) of infant [changes of IGF-1 level of infant from the day of birth to 6 months]

   Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)

7. Brain-derived neurotrophic Factor (BDNF) of infant [changes of BDNF level of infant from the day of birth to 6 months]

   Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)

8. Tumor Growth Factor Beta 1 (TGF beta 1) of infant [changes of TGF Beta 1 level of infant from the day of birth to 6 months]

   Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hasanuddin University Medical Research Center / HUMRC	Makasar	South Sulawesi	Indonesia	90245

Sponsors and Collaborators

• 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: Firdaus Hamid, MD. Ph.D, 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

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Bumi Herman, Assistant Lecturer, Hasanuddin University
• ClinicalTrials.gov Identifier: NCT05100550
• Other Study ID Numbers: 2209210954
• First Posted: Oct 29, 2021
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bumi Herman, Assistant Lecturer, Hasanuddin University: Insulin-like Growth Factor 1; Zinc; Hemoglobin; Health Education; Stunting; Low-income Family
• Additional relevant MeSH terms: Growth Disorders

Study Results

No Results Posted as of Oct 29, 2021