- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06212063
Aim High: Readiness & Meeting the Standards in Military Pre-Recruits
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicole Wesley
- Phone Number: 2257632721
- Email: nicole.wesley@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Contact:
- Nicole Y Wesley
- Phone Number: 2257632771
- Email: nicole.wesley@pbrc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aim High Program
Integrated physical and mental optimization training program used as tool for young individuals readying themselves to join the military
|
Integrated physical and mental optimization training program used as tool for young individuals readying themselves to join the military
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: 16 Months
|
Height for BMI calculations
|
16 Months
|
|
Weight
Time Frame: 16 Months
|
Weight for BMI calculations
|
16 Months
|
|
Body Fat
Time Frame: 16 Months
|
Body Fat % to determine change pre/post program
|
16 Months
|
|
Depression
Time Frame: 16 Months
|
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
|
|
Anxiety
Time Frame: 16 Months
|
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
|
|
Body Esteem
Time Frame: 16 Months
|
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
|
|
Coping
Time Frame: 16 Months
|
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
|
|
Perceived Stress
Time Frame: 16 Months
|
Perceived Stress Scale (PSS); Scores range from 0 to 40, with higher scores meaning higher levels of perceived stress
|
16 Months
|
|
Eating Competence
Time Frame: 16 Months
|
Eating Competence Scale (ecSatter); Scores range from 0 to 48, with higher scores meaning better competence around eating behaviors
|
16 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge & Attitudes
Time Frame: 16 Months
|
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
|
|
Program Satisfaction
Time Frame: 16 Months
|
Questionnaire to determine program acceptability; Higher scores indicate higher satisfaction with program content and delivery
|
16 Months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2023-074
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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