NCT06601959

Brief Summary

The purpose of this study is to investigate the energy needs and nutritional status of adolescent girls in Abia State, Nigeria

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 30, 2026

Status Verified

October 1, 2025

Enrollment Period

2.5 years

First QC Date

September 16, 2024

Last Update Submit

January 29, 2026

Conditions

Keywords

NutritionEnergy requirementsfemale adolescents

Outcome Measures

Primary Outcomes (12)

  • Total Energy Expenditure measured with Doubly Labeled Water (DLW)

    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).

    10 days from enrollment

  • Physical Activity Levels using a wrist-worn accelerometer

    Physical activity levels will be categorized under light, moderate, and vigorous and will be expressed as accelerations over each day. Light 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 This will be reported as the number of participants at each physical activity level.

    10 days from enrollment

  • Dietary Intake using the INDDEX24 app - total energy (kcal/day) content

    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).

    10 days from enrollment

  • Dietary Intake using the INDDEX24 app - macronutrient content

    The INDDEX24 app will be used to assess the macronutrient consumed by each individual per day over the course of the enrollment period.

    10 days from enrollment

  • Dietary Intake using the INDDEX24 app - micronutrient content

    The INDDEX24 app will be used to access the micronutrient content of the diets of the participants for the duration of enrollment.

    10 days from enrollment

  • Body composition - BMI

    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

    10 days from enrollment

  • Body composition - skinfold thickness (biceps)

    Body composition will be assessed by recording biceps skinfold thickness of the participants using skinfold calipers in mm.

    10 days from enrollment

  • Body composition - skinfold thickness (triceps)

    Body composition will be assessed by recording triceps skinfold thickness of the participants using skinfold calipers in mm.

    10 days from enrollment

  • Body composition - skinfold thickness (subscapular)

    Body composition will be assessed by recording subscapular skinfold thickness of the participants using skinfold calipers in mm.

    10 days from enrollment

  • Body composition - skinfold thickness (suprailiac)

    Body composition will be assessed by recording suprailiac skinfold thickness of the participants using skinfold calipers in mm.

    10 days from enrollment

  • Body composition - waist circumference

    Body composition will be assessed by recording the waist circumference of the participants using a tape measure in cm.

    10 days from enrollment

  • Body composition - hip circumference

    Body composition will be assessed by recording the hip circumference of the participants using a tape measure in cm.

    10 days from enrollment

Study Arms (1)

Adolescent female students

Adolescent female students from elementary to secondary schools in the Ikwuano Local Government Area of Abia State, Nigeria

Eligibility Criteria

Age10 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender adolescent girls
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • female students
  • and 19 years old
  • provides verbal assent and has parental consent

You may not qualify if:

  • physical disabilities
  • illnesses during the study period
  • students attending boarding schools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Evolutionary Anthropology

Durham, North Carolina, 27708, United States

Location

Michael Okpara Universty of Agriculture

Umudike, Abia State, Nigeria

Location

Related Publications (11)

  • 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: 7081099BACKGROUND
  • 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: 24489876BACKGROUND
  • 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: 11820686BACKGROUND
  • 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: 35587720BACKGROUND
  • 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: 29141979BACKGROUND
  • 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: 8718497BACKGROUND
  • 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: 8242125BACKGROUND
  • Torun B. Energy requirements of children and adolescents. Public Health Nutr. 2005 Oct;8(7A):968-93. doi: 10.1079/phn2005791.

    PMID: 16277815BACKGROUND
  • 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.

    PMID: 20869489BACKGROUND
  • 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

    BACKGROUND
  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

Study Officials

  • Herman Pontzer

    Duke University Evolutionary Anthropology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

June 27, 2023

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

January 30, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 1 year after publication with no end date
Access Criteria
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: Body Composition Data: Height, waist and hip circumference, skinfold thickness, body weight, and bioelectrical impedance results. Accelerometry Data: Physical activity levels, including step counts, intensity (light, moderate, vigorous), and sedentary behavior over the study period. DLW Data: Total energy expenditure (TEE) estimates derived from the doubly labeled water method. Dietary Intake Data: Nutritional intake recorded via the INDDEX24 app, including energy and macronutrient intake

Locations