Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT06601959
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2024-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Energy Needs and Nutritional Status of Adolescent Girls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Energy Expenditure measured with Doubly Labeled Water (DLW)', 'timeFrame': '10 days from enrollment', 'description': 'The rate of elimination of hydrogen and oxygen isotopes from the DLW through urine will be used to estimate TEE in kilocalories per day (kcal/day).'}, {'measure': 'Physical Activity Levels using a wrist-worn accelerometer', 'timeFrame': '10 days from enrollment', 'description': 'Physical activity levels will be categorized under light, moderate, and vigorous and will be expressed as accelerations over each day.\n\nLight Physical Activity: Acceleration: 0.05 g to 0.1 g Moderate Physical Activity:Acceleration: 0.1 g to 0.3 g Vigorous Physical Activity:Acceleration: ≥ 0.3 g\n\nThis will be reported as the number of participants at each physical activity level.'}, {'measure': 'Dietary Intake using the INDDEX24 app - total energy (kcal/day) content', 'timeFrame': '10 days from enrollment', 'description': 'The INDDEX24 dietary recall app will be used to capture detailed information on all foods and beverages consumed during the recall period. Nutritional intake will be analyzed for total energy (kcal/day).'}, {'measure': 'Dietary Intake using the INDDEX24 app - macronutrient content', 'timeFrame': '10 days from enrollment', 'description': 'The INDDEX24 app will be used to assess the macronutrient consumed by each individual per day over the course of the enrollment period.'}, {'measure': 'Dietary Intake using the INDDEX24 app - micronutrient content', 'timeFrame': '10 days from enrollment', 'description': 'The INDDEX24 app will be used to access the micronutrient content of the diets of the participants for the duration of enrollment.'}, {'measure': 'Body composition - BMI', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording the heights and weights of the participants with a tape measure and body scale respectively to calculate their body mass indices (BMI) in kg/m\\^2'}, {'measure': 'Body composition - skinfold thickness (biceps)', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording biceps skinfold thickness of the participants using skinfold calipers in mm.'}, {'measure': 'Body composition - skinfold thickness (triceps)', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording triceps skinfold thickness of the participants using skinfold calipers in mm.'}, {'measure': 'Body composition - skinfold thickness (subscapular)', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording subscapular skinfold thickness of the participants using skinfold calipers in mm.'}, {'measure': 'Body composition - skinfold thickness (suprailiac)', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording suprailiac skinfold thickness of the participants using skinfold calipers in mm.'}, {'measure': 'Body composition - waist circumference', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording the waist circumference of the participants using a tape measure in cm.'}, {'measure': 'Body composition - hip circumference', 'timeFrame': '10 days from enrollment', 'description': 'Body composition will be assessed by recording the hip circumference of the participants using a tape measure in cm.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nutrition', 'Energy requirements', 'female adolescents'], 'conditions': ['Nutrition', 'Energy Requirement']}, 'referencesModule': {'references': [{'pmid': '7081099', 'type': 'BACKGROUND', 'citation': 'Fomon SJ, Haschke F, Ziegler EE, Nelson SE. Body composition of reference children from birth to age 10 years. Am J Clin Nutr. 1982 May;35(5 Suppl):1169-75. doi: 10.1093/ajcn/35.5.1169. No abstract available.'}, {'pmid': '24489876', 'type': 'BACKGROUND', 'citation': 'Oyeyemi AL, Umar M, Oguche F, Aliyu SU, Oyeyemi AY. Accelerometer-determined physical activity and its comparison with the International Physical Activity Questionnaire in a sample of Nigerian adults. PLoS One. 2014 Jan 28;9(1):e87233. doi: 10.1371/journal.pone.0087233. eCollection 2014.'}, {'pmid': '11820686', 'type': 'BACKGROUND', 'citation': 'Boreham C, Riddoch C. The physical activity, fitness and health of children. J Sports Sci. 2001 Dec;19(12):915-29. doi: 10.1080/026404101317108426.'}, {'pmid': '35587720', 'type': 'BACKGROUND', 'citation': 'Coates J, Bell W, Bakun P, Adams KP, Some JW, Colaiezzi B, Do HTP, Rogers B. Accuracy and cost-effectiveness of the INDDEX24 Dietary Assessment Platform in Viet Nam. Br J Nutr. 2023 May 28;129(10):1751-1764. doi: 10.1017/S0007114522001507. Epub 2022 May 19.'}, {'pmid': '29141979', 'type': 'BACKGROUND', 'citation': 'Gibson RS, Charrondiere UR, Bell W. Measurement Errors in Dietary Assessment Using Self-Reported 24-Hour Recalls in Low-Income Countries and Strategies for Their Prevention. Adv Nutr. 2017 Nov 15;8(6):980-991. doi: 10.3945/an.117.016980. Print 2017 Nov.'}, {'pmid': '8718497', 'type': 'BACKGROUND', 'citation': 'Schutz Y. The basis of direct and indirect calorimetry and their potentials. Diabetes Metab Rev. 1995 Dec;11(4):383-408. doi: 10.1002/dmr.5610110406. No abstract available.'}, {'pmid': '8242125', 'type': 'BACKGROUND', 'citation': 'Murgatroyd PR, Shetty PS, Prentice AM. Techniques for the measurement of human energy expenditure: a practical guide. Int J Obes Relat Metab Disord. 1993 Oct;17(10):549-68.'}, {'pmid': '16277815', 'type': 'BACKGROUND', 'citation': 'Torun B. Energy requirements of children and adolescents. Public Health Nutr. 2005 Oct;8(7A):968-93. doi: 10.1079/phn2005791.'}, {'pmid': '20869489', 'type': 'BACKGROUND', 'citation': 'Burrows TL, Martin RJ, Collins CE. A systematic review of the validity of dietary assessment methods in children when compared with the method of doubly labeled water. J Am Diet Assoc. 2010 Oct;110(10):1501-10. doi: 10.1016/j.jada.2010.07.008.'}, {'type': 'BACKGROUND', 'citation': 'Ukegbu PO. Energy intake, expenditure and body composition of adolescent boys and girls in public boarding secondary schools in Umuahia, Nigeria. J Biol Agric Healthc. 2012;2(8):33-9. Available from: https://iiste.org/Journals/index.php/JBAH/article/view/2860'}, {'pmid': '41056327', 'type': 'DERIVED', 'citation': "Adegboyega MT, Amaeze CA, Uche CP, Ukegbu PO, Pontzer H. Study protocol for measuring energy needs and nutritional status of adolescent girls in Abia state, Nigeria: The nutrition and adolescence in rural Nigeria (NARN'ia) Study. PLoS One. 2025 Oct 7;20(10):e0333889. doi: 10.1371/journal.pone.0333889. eCollection 2025."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the energy needs and nutritional status of adolescent girls in Abia State, Nigeria', 'detailedDescription': "Adolescents in low and middle-income countries encounter numerous nutritional challenges, including undernutrition, micronutrient deficiencies, poor dietary habits, and food insecurity. These issues significantly impact their growth, development, and long-term health. Despite their increased vulnerability, this demographic is often overlooked in nutritional program planning and implementation. This neglect is due to a lack of accurate data, inadequate delivery platforms for interventions, and underdeveloped policies and programs.\n\nThe Nutrition and Adolescence in Rural Nigeria (NARN'ia) study aims to address this gap through a comprehensive assessment of energy requirements in adolescent girls (N=50; ages 10 - 19 years) in Nigeria. NARN'ia will integrate dietary assessments using the 24-hour recall method (INDDEX24 app); physical activity levels using accelerometry; anthropometric evaluations of body composition, and the doubly labeled water method for assessing both body composition and total daily energy expenditure.\n\nThis study will provide evidence-based data essential for formulating appropriate nutritional guidelines for adolescent girls in Nigeria. Furthermore, this research initiative will establish a foundational framework for future studies on energy requirements in Nigeria and other low and middle-income countries."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '10 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The NARN'ia study will be conducted in Ikwuano Local Government Area of Abia State, located in southeast Nigeria. Ikwuano is a rural region primarily inhabited by crop farmers and traders from the Igbo ethnic group. Participants (n=50) will be recruited from four secondary schools in Ikwuano.", 'genderDescription': 'Cisgender adolescent girls', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female students\n* 10 and 19 years old\n* provides verbal assent and has parental consent\n\nExclusion Criteria:\n\n* physical disabilities\n* illnesses during the study period\n* students attending boarding schools'}, 'identificationModule': {'nctId': 'NCT06601959', 'acronym': 'NARNia', 'briefTitle': 'Energy Needs and Nutritional Status of Adolescent Girls', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': "Study Protocol for Measuring Energy Needs and Nutritional Status of Adolescent Girls in Abia State, Nigeria: The Nutrition and Adolescence in Rural Nigeria (NARN'ia) Study", 'orgStudyIdInfo': {'id': 'Pro00114378'}, 'secondaryIdInfos': [{'id': 'INV-061141', 'type': 'OTHER_GRANT', 'domain': 'Bill and Melinda Gates Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adolescent female students', 'description': 'Adolescent female students from elementary to secondary schools in the Ikwuano Local Government Area of Abia State, Nigeria'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Duke University Evolutionary Anthropology', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Umudike', 'state': 'Abia State', 'status': 'RECRUITING', 'country': 'Nigeria', 'contacts': [{'name': 'Patricia Ukegbu', 'role': 'CONTACT', 'email': 'ukegbu.patricia@mouau.edu.ng', 'phone': '+234 803 428 9406'}, {'name': 'Augusta Amaeze', 'role': 'CONTACT', 'email': 'chigozirimmgbaja@gmail.com', 'phone': '+234 813 408 1777'}], 'facility': 'Michael Okpara Universty of Agriculture', 'geoPoint': {'lat': 5.50114, 'lon': 7.53802}}], 'centralContacts': [{'name': 'Emily Hyatt', 'role': 'CONTACT', 'email': 'emily.hyatt@duke.edu', 'phone': '(919) 684-4124'}, {'name': 'Mayowa Adegboyega', 'role': 'CONTACT', 'email': 'mayowa.adegboyega@duke.edu', 'phone': '(202) 705-1876'}], 'overallOfficials': [{'name': 'Herman Pontzer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Evolutionary Anthropology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 1 year after publication with no end date', 'ipdSharing': 'YES', 'description': "Anonymized individual participant data (IPD) from this study, including measurements of body composition (height, waist circumference, hip circumference, skinfold thickness, body weight, and bioelectrical impedance results), physical activity levels (accelerometry data), total energy expenditure (DLW data), and dietary intake (INDDEX24 app data), will be made available upon reasonable request. All personal identifiers will be removed to ensure participants' privacy and confidentiality.", 'accessCriteria': "Researchers interested in accessing the anonymized dataset must submit a formal request outlining the intended use of the data. Requests will be reviewed by the study's principal investigator to ensure appropriate use. Data access will be granted through a secure data-sharing platform, and users will be required to sign a data-sharing agreement to ensure that the data is used exclusively for research purposes and in line with ethical guidelines. The shared dataset will include:\n\nBody Composition Data: Height, waist and hip circumference, skinfold thickness, body weight, and bioelectrical impedance results.\n\nAccelerometry Data: Physical activity levels, including step counts, intensity (light, moderate, vigorous), and sedentary behavior over the study period.\n\nDLW Data: Total energy expenditure (TEE) estimates derived from the doubly labeled water method.\n\nDietary Intake Data: Nutritional intake recorded via the INDDEX24 app, including energy and macronutrient intake"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bill and Melinda Gates Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}