Clinical trial NCT06601959: Energy Needs and Nutritional Status of Adolescent Girls
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutrition
Energy Requirement
Keywords: Nutrition
Energy requirements
female adolescents
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2024-09-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 19
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Total Energy Expenditure measured with Doubly Labeled Water (DLW)
timeFrame: 10 days from enrollment
measure: Physical Activity Levels using a wrist-worn accelerometer
timeFrame: 10 days from enrollment
measure: Dietary Intake using the INDDEX24 app - total energy (kcal/day) content
timeFrame: 10 days from enrollment
measure: Dietary Intake using the INDDEX24 app - macronutrient content
timeFrame: 10 days from enrollment
measure: Dietary Intake using the INDDEX24 app - micronutrient content
timeFrame: 10 days from enrollment
measure: Body composition - BMI
timeFrame: 10 days from enrollment
measure: Body composition - skinfold thickness (biceps)
timeFrame: 10 days from enrollment
measure: Body composition - skinfold thickness (triceps)
timeFrame: 10 days from enrollment
measure: Body composition - skinfold thickness (subscapular)
timeFrame: 10 days from enrollment
measure: Body composition - skinfold thickness (suprailiac)
timeFrame: 10 days from enrollment
measure: Body composition - waist circumference
timeFrame: 10 days from enrollment
measure: Body composition - hip circumference
timeFrame: 10 days from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Evolutionary Anthropology
state: North Carolina
city: Umudike
country: Nigeria
facility: Michael Okpara Universty of Agriculture
state: Abia State
Study officials:
affiliation: Duke University Evolutionary Anthropology
name: Herman Pontzer
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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