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

NCT05100550 | Unknown

• 1 other identifier: 2209210954
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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. 1.To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother
2. 2.1\. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother

Conditions

Stunting; Maternal-Fetal Relations

Keywords

Insulin-like Growth Factor 1; Zinc; Hemoglobin; Health Education; Stunting; Low-income Family

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Hemoglobin level of mother

  changes of hemoglobin level of mother from the baseline to delivery time

• 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 in breast milk

  changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery

• Hemoglobin level of infant

  changes of hemoglobin level of infant from the day of birth to 6 months

• Insulin-like growth factor 1 (IGF-1) of mother

  changes of IGF-1 level of mother from the baseline to day of delivery

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Dietary Supplement: Zinc

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Zinc DIETARY_SUPPLEMENT

Zinc is given as written in the arm description, two hours after lunch

Intervention

Control OTHER

This group will not receive zinc

Control

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: This study focus on a pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body height is less than 150 cm
• Upper Arm Circumference less than 23.5 cm
• Family income is less than Rp 2,500,000,- following the minimum wage of targeted area
• weeks pregnant.

You may not qualify if:

• has pregnancy complications
• multiple infants
• refuse to follow the protocol

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Hasanuddin University Medical Research Center / HUMRC

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

Related 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.

  PMID: 33676424 BACKGROUND

• 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.

  PMID: 27754451 BACKGROUND

• 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.

  PMID: 29143677 BACKGROUND

• 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.

  PMID: 25527182 BACKGROUND

• 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.

  PMID: 26365330 BACKGROUND

MeSH Terms

Conditions

Growth Disorders; Health Education

Interventions

Zinc

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halisah Halisah, M.Keb

CONTACT

+6285341247477; armiyatinur@gmail.com

Halisah Halisah, M.Keb

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 29, 2021
• Study Start: September 1, 2020
• Primary Completion: November 15, 2021
• Study Completion: December 1, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)