Family-based Health Education Program and Zinc Supplementation for Stunted Mother
NCT ID: NCT05100550
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
126 participants
INTERVENTIONAL
2020-09-01
2021-12-01
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
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.
Zinc
Zinc is given as written in the arm description, two hours after lunch
Control
Standard antenatal care for third trimester will be applied without supplementation of zinc
Control
This group will not receive zinc
Interventions
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Zinc
Zinc is given as written in the arm description, two hours after lunch
Control
This group will not receive zinc
Eligibility Criteria
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Inclusion Criteria
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
2. multiple infants
3. refuse to follow the protocol
19 Years
FEMALE
Yes
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Agussalim Bukhari, MD.Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Nurpudji A Taslim, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Aidah Baso, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Sitti MT Chalid, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Kadek Erika, RN
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Nasrudin Mappaware, MD
Role: PRINCIPAL_INVESTIGATOR
Muslim University Indonesia
Mardiana Ahmad, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Firdaus Hamid, MD. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Suryani As'ad, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Rosdiana Natsir, Prof
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Martira Maddepungeng, MD
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Rian Pamungkas, RN, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Esa Unggul University
Halisah Wahyuningsih, MW.
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Wahyuningsih Wahyuningsih, RN
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Armiyati Nur, MW
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Hasanuddin University Medical Research Center / HUMRC
Makassar, South Sulawesi, Indonesia
Countries
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Central Contacts
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Halisah Halisah, M.Keb
Role: CONTACT
Facility Contacts
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Bumi Herman, M.D, Ph.D
Role: primary
References
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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.
Other Identifiers
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2209210954
Identifier Type: -
Identifier Source: org_study_id