Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT05100550
Status:
UNKNOWN
Last Update Posted:
2021-10-29
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family-based Health Education Program and Zinc Supplementation for Stunted Mother
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015032', 'term': 'Zinc'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group is assigned for health education intervention and zinc supplementation, and the comparison group receives only standard antenatal care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-20', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant weight', 'timeFrame': 'changes of weight at birth up to 6 months', 'description': 'This includes weight at birth, weight at 3 months and 6 months'}, {'measure': 'Infant Length', 'timeFrame': 'changes of length at birth up to 6 months', 'description': 'This includes length of body at birth, at 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin level of mother', 'timeFrame': 'changes of hemoglobin level of mother from the baseline to delivery time', 'description': 'Hemoglobin level of mother measured in blood using hematology analyzer'}, {'measure': 'Zinc level of mother in blood', 'timeFrame': 'changes of Zinc in blood of mother from the baseline to 6 months after delivery', 'description': 'Zinc level of mother measured in blood using hematology analyzer'}, {'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', 'description': 'Zinc level of mother measured in blood using atomic absorption spectrometric'}, {'measure': 'Hemoglobin level of infant', 'timeFrame': 'changes of hemoglobin level of infant from the day of birth to 6 months', 'description': 'Hemoglobin level of infant measured in blood using hematology analyzer'}, {'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', 'description': 'Insulin-like growth factor 1 (IGF-1) of mother measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)'}, {'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', 'description': 'Insulin-like growth factor 1 (IGF-1) of infant measured in blood using Human IGF-1 enzyme-linked Immunosorbent Assay (ELISA)'}, {'measure': 'Brain-derived neurotrophic Factor (BDNF) of infant', 'timeFrame': 'changes of BDNF level of infant from the day of birth to 6 months', 'description': 'Brain-derived neurotrophic Factor (BDNF) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)'}, {'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', 'description': 'Tumor Growth Factor Beta 1 (TGF beta 1) of infant measured in blood using enzyme-linked Immunosorbent Assay (ELISA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Insulin-like Growth Factor 1', 'Zinc', 'Hemoglobin', 'Health Education', 'Stunting', 'Low-income Family'], 'conditions': ['Stunting', 'Maternal-Fetal Relations']}, 'referencesModule': {'references': [{'pmid': '33676424', 'type': 'BACKGROUND', '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.'}, {'pmid': '27754451', 'type': 'BACKGROUND', '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.'}, {'pmid': '29143677', 'type': 'BACKGROUND', '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."}, {'pmid': '25527182', 'type': 'BACKGROUND', '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.'}, {'pmid': '26365330', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Background :\n\nIt 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.\n\nObjective :\n\n1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother\n2. 1\\. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother\n\nMethodology :\n\nA Quasi-experimental study involving stunted pregnant mother with parallel intervention\n\nHypothesis :\n\nMother who receives the intervention will have the better maternal and neonatal outcome', 'detailedDescription': 'Details of Family-Based Health Education Program + Zinc :\n\n1. Home-visit and health promotion by trained midwives\n2. Supervision by health volunteer\n3. Zinc Supplementation\n\nGeneral target population :\n\n1. Stunted pregnant mother on the third trimester of pregnancy\n2. Conducted in Primary Health Care Center\n\nDesign of Study :\n\ntwo 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\n\nVariable :\n\n1. Sociodemographic information\n2. Food recall using Food Frequency Questionnaire\n\nList of outcomes\n\n1. Zinc level in breastmilk and blood of mother and infant\n2. Insulin-like growth factor 1 (IGF-1) level of mother and infant\n3. Hemoglobin level of mother and infant\n4. Infant and placental anthropometry\n5. Tumor growth Factor Beta 1 (TGF beta 1) in infant\n6. Brain-derived neurotrophic factor (BDNF) in infant\n\nSample 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\n\n1. Type 1 error 5%\n2. Effect size: 0.4486\n3. Power of study: 80%\n4. With the equal allocation ratio, the total sample needed is 126\n\nProposed statistical analysis\n\n1. Independent T-test\n2. Linear Mixed Model'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'This study focus on a pregnant woman', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Body height is less than 150 cm\n2. Upper Arm Circumference less than 23.5 cm\n3. Family income is less than Rp 2,500,000,- following the minimum wage of targeted area\n4. 24-26 weeks pregnant.\n\nExclusion Criteria\n\n1. has pregnancy complications\n2. multiple infants\n3. refuse to follow the protocol'}, 'identificationModule': {'nctId': 'NCT05100550', 'briefTitle': 'Family-based Health Education Program and Zinc Supplementation for Stunted Mother', 'organization': {'class': 'OTHER', 'fullName': 'Hasanuddin University'}, 'officialTitle': 'Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby', 'orgStudyIdInfo': {'id': '2209210954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'This group will receive\n\n1. Health education regarding nutrition in pregnancy (including the importance of micronutrients, recognizing malnutrition, practicing breastfeeding)\n2. Screening of Low birth weight risk\n3. Zinc Supplementation 20 mg/daily from gestation week for 12 weeks, followed by 12 weeks of supplementation on the third day postpartum.', 'interventionNames': ['Dietary Supplement: Zinc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Standard antenatal care for third trimester will be applied without supplementation of zinc', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Zinc', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Zinc is given as written in the arm description, two hours after lunch', 'armGroupLabels': ['Intervention']}, {'name': 'Control', 'type': 'OTHER', 'description': 'This group will not receive zinc', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90245', 'city': 'Makassar', 'state': 'South Sulawesi', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Bumi Herman, M.D, Ph.D', 'role': 'CONTACT', 'email': 'bumiherman@med.unhas.ac.id'}, {'name': 'Bumi Herman, M.D Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Firman Hasan, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karina Patricia, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Muthiah Abustani, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hasanuddin University Medical Research Center / HUMRC', 'geoPoint': {'lat': -5.14861, 'lon': 119.43194}}], 'centralContacts': [{'name': 'Halisah Halisah, M.Keb', 'role': 'CONTACT', 'email': 'armiyatinur@gmail.com', 'phone': '+6285341247477'}, {'name': 'Halisah Halisah, M.Keb', 'role': 'CONTACT'}], 'overallOfficials': [{'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': 'Hasanuddin University'}, {'name': 'Nasrudin Mappaware, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Muslim University Indonesia'}, {'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': 'Hasanuddin University'}, {'name': 'Rian Pamungkas, RN, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Esa Unggul 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', 'affiliation': 'Hasanuddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Deidentified data will be shared accordingly'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasanuddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Bumi Herman', 'investigatorAffiliation': 'Hasanuddin University'}}}}