Clinical trial NCT05100550: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stunting
Maternal-Fetal Relations
Keywords: Insulin-like Growth Factor 1
Zinc
Hemoglobin
Health Education
Stunting
Low-income Family
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 126
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.
Primary purpose: SUPPORTIVE_CARE

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Infant weight
timeFrame: changes of weight at birth up to 6 months
measure: Infant Length
timeFrame: changes of length at birth up to 6 months
Secondary outcomes:
measure: Hemoglobin level of mother
timeFrame: changes of hemoglobin level of mother from the baseline to delivery time
measure: Zinc level of mother in blood
timeFrame: changes of Zinc in blood of mother from the baseline to 6 months after delivery
measure: Zinc level of mother in breast milk
timeFrame: changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery
measure: Hemoglobin level of infant
timeFrame: changes of hemoglobin level of infant from the day of birth to 6 months
measure: Insulin-like growth factor 1 (IGF-1) of mother
timeFrame: changes of IGF-1 level of mother from the baseline to day of delivery
measure: Insulin-like growth factor 1 (IGF-1) of infant
timeFrame: changes of IGF-1 level of infant from the day of birth to 6 months
measure: Brain-derived neurotrophic Factor (BDNF) of infant
timeFrame: changes of BDNF level of infant from the day of birth to 6 months
measure: Tumor Growth Factor Beta 1 (TGF beta 1) of infant
timeFrame: changes of TGF Beta 1 level of infant from the day of birth to 6 months
Other outcomes:
Locations:
city: Makasar
country: Indonesia
facility: Hasanuddin University Medical Research Center / HUMRC
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Agussalim Bukhari, MD.Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Nurpudji A Taslim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Aidah Baso, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Sitti MT Chalid, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Kadek Erika, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Muslim University Indonesia
name: Nasrudin Mappaware, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Mardiana Ahmad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Firdaus Hamid, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Suryani As'ad, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Rosdiana Natsir, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Martira Maddepungeng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Esa Unggul University
name: Rian Pamungkas, RN, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Halisah Wahyuningsih, MW.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Wahyuningsih Wahyuningsih, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasanuddin University
name: Armiyati Nur, MW
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.