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NutritionNARNiaNCT06601959

Energy Needs and Nutritional Status of Adolescent Girls

An observational study of Nutrition and Energy Requirement, run by Duke University at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 10 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Nutrition, Energy Requirement
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
27 Jun 2023to 15 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Duke University Evolutionary Anthropology

    Durham, North Carolina, 27708

Other trials in United States

Nigeria1 site

  • Michael Okpara Universty of Agriculture

    Umudike, Abia State

Other trials in Nigeria

About this study

Official title: 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

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

Read the detailed description

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.

The 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.

This 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.

Keywords
Nutrition, Energy requirements, female adolescents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06601959
Study groupRoleWhat they receive
Adolescent female studentsAdolescent female students from elementary to secondary schools in the Ikwuano Local Government Area of Abia State, Nigeria

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 10 days from enrollment

  2. 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.

    Measured: 10 days from enrollment

  3. 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).

    Measured: 10 days from enrollment

  4. 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.

    Measured: 10 days from enrollment

  5. 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.

    Measured: 10 days from enrollment

  6. 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

    Measured: 10 days from enrollment

  7. Body composition - skinfold thickness (biceps)

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

    Measured: 10 days from enrollment

  8. Body composition - skinfold thickness (triceps)

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

    Measured: 10 days from enrollment

  9. Body composition - skinfold thickness (subscapular)

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

    Measured: 10 days from enrollment

  10. Body composition - skinfold thickness (suprailiac)

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

    Measured: 10 days from enrollment

  11. Body composition - waist circumference

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

    Measured: 10 days from enrollment

  12. Body composition - hip circumference

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

    Measured: 10 days from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start27 Jun 2023
  3. Primary completion15 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06601959
Sponsor's protocol ID
Pro00114378
Other IDs
INV-061141
Acronym
NARNia
Status last verified
Oct 2025
First submitted
16 Sep 2024
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 7081099

  • 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.

    PubMed 24489876

  • 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.

    PubMed 11820686

  • 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.

    PubMed 35587720

  • 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.

    PubMed 29141979

  • 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.

    PubMed 8718497

  • 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.

    PubMed 8242125

  • Torun B. Energy requirements of children and adolescents. Public Health Nutr. 2005 Oct;8(7A):968-93. doi: 10.1079/phn2005791.

    PubMed 16277815

  • 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.

    PubMed 20869489

  • 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

  • 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.

    PubMed 41056327

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition and Energy Requirement, run by Duke University at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Energy Expenditure measured with Doubly Labeled Water (DLW) (time frame: 10 days from enrollment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06601959, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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