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

Primary Purpose

Stunting, Maternal-Fetal Relations

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Zinc
Control
Sponsored by
Hasanuddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stunting focused on measuring Insulin-like Growth Factor 1, Zinc, Hemoglobin, Health Education, Stunting, Low-income Family

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hasanuddin University Medical Research Center / HUMRCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hemoglobin level of mother
Hemoglobin level of mother measured in blood using hematology analyzer
Zinc level of mother in blood
Zinc level of mother measured in blood using hematology analyzer
Zinc level of mother in breast milk
Zinc level of mother measured in blood using atomic absorption spectrometric
Hemoglobin level of infant
Hemoglobin level of infant measured in blood using hematology analyzer
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)
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)
Brain-derived neurotrophic Factor (BDNF) of infant
Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
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)

Full Information

First Posted
October 20, 2021
Last Updated
October 20, 2021
Sponsor
Hasanuddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05100550
Brief Title
Family-based Health Education Program and Zinc Supplementation for Stunted Mother
Official Title
Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasanuddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 : To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother 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
Details of Family-Based Health Education Program + Zinc : Home-visit and health promotion by trained midwives Supervision by health volunteer Zinc Supplementation General target population : Stunted pregnant mother on the third trimester of pregnancy 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 : Sociodemographic information Food recall using Food Frequency Questionnaire List of outcomes Zinc level in breastmilk and blood of mother and infant Insulin-like growth factor 1 (IGF-1) level of mother and infant Hemoglobin level of mother and infant Infant and placental anthropometry Tumor growth Factor Beta 1 (TGF beta 1) in infant 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 Type 1 error 5% Effect size: 0.4486 Power of study: 80% With the equal allocation ratio, the total sample needed is 126 Proposed statistical analysis Independent T-test Linear Mixed Model

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Maternal-Fetal Relations
Keywords
Insulin-like Growth Factor 1, Zinc, Hemoglobin, Health Education, Stunting, Low-income Family

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard antenatal care for third trimester will be applied without supplementation of zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Description
Zinc is given as written in the arm description, two hours after lunch
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
This group will not receive zinc
Primary Outcome Measure Information:
Title
Infant weight
Description
This includes weight at birth, weight at 3 months and 6 months
Time Frame
changes of weight at birth up to 6 months
Title
Infant Length
Description
This includes length of body at birth, at 3 months and 6 months
Time Frame
changes of length at birth up to 6 months
Secondary Outcome Measure Information:
Title
Hemoglobin level of mother
Description
Hemoglobin level of mother measured in blood using hematology analyzer
Time Frame
changes of hemoglobin level of mother from the baseline to delivery time
Title
Zinc level of mother in blood
Description
Zinc level of mother measured in blood using hematology analyzer
Time Frame
changes of Zinc in blood of mother from the baseline to 6 months after delivery
Title
Zinc level of mother in breast milk
Description
Zinc level of mother measured in blood using atomic absorption spectrometric
Time Frame
changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery
Title
Hemoglobin level of infant
Description
Hemoglobin level of infant measured in blood using hematology analyzer
Time Frame
changes of hemoglobin level of infant from the day of birth to 6 months
Title
Insulin-like growth factor 1 (IGF-1) of mother
Description
Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Time Frame
changes of IGF-1 level of mother from the baseline to day of delivery
Title
Insulin-like growth factor 1 (IGF-1) of infant
Description
Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)
Time Frame
changes of IGF-1 level of infant from the day of birth to 6 months
Title
Brain-derived neurotrophic Factor (BDNF) of infant
Description
Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
Time Frame
changes of BDNF level of infant from the day of birth to 6 months
Title
Tumor Growth Factor Beta 1 (TGF beta 1) of infant
Description
Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)
Time Frame
changes of TGF Beta 1 level of infant from the day of birth to 6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study focus on a pregnant woman
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria 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 24-26 weeks pregnant. Exclusion Criteria has pregnancy complications multiple infants refuse to follow the protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Halisah Halisah, M.Keb
Phone
+6285341247477
Email
armiyatinur@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Halisah Halisah, M.Keb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agussalim Bukhari, MD.Ph.D
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nurpudji A Taslim, Prof
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aidah Baso, MD. Ph.D
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sitti MT Chalid, MD. Ph.D
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kadek Erika, RN
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasrudin Mappaware, MD
Organizational Affiliation
Muslim University Indonesia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mardiana Ahmad, MD
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Firdaus Hamid, MD. Ph.D
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suryani As'ad, Prof
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosdiana Natsir, Prof
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martira Maddepungeng, MD
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rian Pamungkas, RN, Ph.D
Organizational Affiliation
Esa Unggul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Halisah Wahyuningsih, MW.
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wahyuningsih Wahyuningsih, RN
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Armiyati Nur, MW
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasanuddin University Medical Research Center / HUMRC
City
Makasar
State/Province
South Sulawesi
ZIP/Postal Code
90245
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bumi Herman, M.D, Ph.D
Email
bumiherman@med.unhas.ac.id
First Name & Middle Initial & Last Name & Degree
Bumi Herman, M.D Ph.D
First Name & Middle Initial & Last Name & Degree
Firman Hasan, M.D
First Name & Middle Initial & Last Name & Degree
Karina Patricia, M.D
First Name & Middle Initial & Last Name & Degree
Muthiah Abustani, M.D

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified data will be shared accordingly
Citations:
PubMed Identifier
33676424
Citation
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.
Results Reference
background
PubMed Identifier
27754451
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):641. doi: 10.3390/nu8100641.
Results Reference
background
PubMed Identifier
29143677
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. No abstract available.
Results Reference
background
PubMed Identifier
25527182
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.
Results Reference
background
PubMed Identifier
26365330
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.
Results Reference
background

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

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