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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06212063
Other study ID # PBRC 2023-074
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 15, 2024
Est. completion date January 15, 2027

Study information

Verified date April 2024
Source Pennington Biomedical Research Center
Contact Nicole Wesley
Phone 2257632721
Email nicole.wesley@pbrc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of the proposed study is to complete a comprehensive needs assessment of the Louisiana National Guard (LANG) Youth Challenge Program (YCP) in the YCP leadership and junior cadet population related to nutrition, fitness, sleep, and mental health and resilience. Results of this needs assessment will further inform the development of the intervention skills training program. The secondary objective of this work is to provide a scalable, integrated physical and mental optimization training program that would be integrated into relevant systems and maintained over time as a core tool for young individuals readying themselves to join the Army. The program would include an environmental intervention approach as well as nutrition, physical activity, sleep, and stress reduction/positive coping guidance.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date January 15, 2027
Est. primary completion date January 15, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Must be either staff, cadre, or cadets in the YCP program. Exclusion Criteria: - Not staff, cadre, or cadets in the YCP program.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cadet Health
Integrated physical and mental optimization training program used as tool for young individuals readying themselves to join the military

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pennington Biomedical Research Center

Outcome

Type Measure Description Time frame Safety issue
Primary Height Height for BMI calculations 16 Months
Primary Weight Weight for BMI calculations 16 Months
Primary Body Fat Body Fat % to determine change pre/post program 16 Months
Primary Depression Patient Health Questionnaire for Adolescents (PHQ-8A) to determine change pre/post program; Scores range from 0 to 24, with a higher score meaning higher levels of depressive symptomology 16 Months
Primary Anxiety Generalized Anxiety Disorder Screener (GAD7) to determine change pre/post program; Score range from 0 to 21, with higher scores meaning higher levels of anxiety 16 Months
Primary Body Esteem Body Esteem Scale for Adolescent and Adults (BESAA) to determine change pre/post program; scores range from 0 to 92, with higher scores meaning higher levels of body esteem. 16 Months
Primary Coping Brief COPE; 14 facets of coping skills are assessed and can be consolidated into approach and avoidant coping strategies, with higher scores indicating higher levels of that particular coping strategy 16 Months
Primary Perceived Stress Perceived Stress Scale (PSS); Scores range from 0 to 40, with higher scores meaning higher levels of perceived stress 16 Months
Primary Eating Competence Eating Competence Scale (ecSatter); Scores range from 0 to 48, with higher scores meaning better competence around eating behaviors 16 Months
Secondary Knowledge & Attitudes General Questionnaire to assess uptake of knowledge presented in the program; Higher scores will indicate higher levels of understanding of key program concepts 16 Months
Secondary Program Satisfaction Questionnaire to determine program acceptability; Higher scores indicate higher satisfaction with program content and delivery 16 Months
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