Military Health and Nutrition Examination Study
- Conditions
- HypertensionDyslipidemiasType 2 DiabetesCardiovascular Diseases
- Registration Number
- NCT06380322
- Lead Sponsor
- Pennington Biomedical Research Center
- Brief Summary
The Military Health and Nutrition Examination Study (MHANES) is a Department of Defense funded study conducted by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study will assess, in a large, diverse sample of Army Service Members (n=600), food and supplement intake, cardiovascular health, body composition, biomarkers of nutritional status, measures of health status, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance outcomes. The proposed study is modeled after the National Health and Nutrition Examination Survey (NHANES) and customized for the Army population.
- Detailed Description
Background: Comprehensive scientific data on dietary intake, nutritional status, cardiometabolic health, and performance of a representative sample of active-duty Soldiers are not available. Collecting such data will allow for assessment of disease prevalence and health status, provide novel descriptive information, and examine relationships between health and nutrition variables that are currently unavailable on the Army active-duty population.
Study Aim: To assess, in a large, diverse sample of Army Service Members, dietary intake, nutritional status, cardiovascular health, body composition, metabolic biomarkers of nutritional state, and other measures of health status.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- U.S. Army Soldiers ≥ 18 years old
- Willing to have biological samples stored for future use
- Willing to have data linked to the Soldier Performance, Health, and Readiness (SPHERE) database
- Soldiers under the age of 18 years
- Soldiers with an inability to understand verbal or written instructions or testing materials in English
- Soldiers relocating or getting out of the Army in the next 30 days
- Pregnant females
- Soldiers currently in Basic Training (BCT) and/or One-Station Unit Training (OSUT)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dietary intake This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later 24-hour dietary recalls will be collected using ASA24® to measure intake of macronutrients (protein, carbohydrate, and fat) and micronutrients (vitamins and minerals).
Dietary quality This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later 24-hour dietary recalls will be collected using ASA24®. Diet quality will be assessed by the healthy eating index (HEI).
- Secondary Outcome Measures
Name Time Method Mood Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Mood state will be assessed by the Profile of Mood States 2 (POMS2) questionnaire.
Sleep duration and quality Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Sleep duration and quality will be assessed by using the Pittsburgh Sleep Quality Index (PSQI).
Eating behavior (Fast Eating Rate) Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Assessed using the Fast Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)
Resting metabolic rate (RMR) Measured one time at visit 1 (within 1-2 weeks of study enrollment). Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter).
Posttraumatic stress disorder Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Posttraumatic stress disorder (PTSD) will be assessed by the the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).
Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation Measured one time at visit 1 (within 1-2 weeks of study enrollment). Measured in blood
Genomics Measured one time at visit 1 (within 1-2 weeks of study enrollment). Array-based genotyping using blood samples
Depression Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9).
Anxiety Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Anxiety will be assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire.
Heart rate variability (HRV) Measured one time at visit 1 (within 1-2 weeks of study enrollment). Heart rate variations will be continuously recorded for 10 minutes with the Zephyr Bioharness™ (Zephyr Technology Corporation, Annapolis, MD, US).
Resilience Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Resilience will be assessed by the Connor-Davidson Resilience Scale (CD-RISC).
Physical injuries Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). A questionnaire on orthopedic injuries will be administered.
Eating behavior (Satiety) Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Assessed using the Satiety scale derived from the validated Military Eating Behavior Survey (MEBS)
Self-efficacy Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Self-efficacy will be assessed by the Generalized Self-Efficacy Scale (GSE).
Physical activity Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Physical activity will be assessed by the Physical Activity and Physical Fitness Questionnaire from NHANES.
Physical performance Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment). Participants will self-report their most recent Army Combat Fitness Test (ACFT) results.
Eating behavior (Slow Eating Rate) Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment). Assessed using the Slow Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)
Blood pressure Measured one time at visit 1 (within 1-2 weeks of study enrollment). Measured after an overnight (at least 10 hour) fast, blood pressure will be measured with an automated cuff.
Anthropometric and body composition measures Measured one time at visit 1 (within 1-2 weeks of study enrollment). Height measured using a stadiometer. Body mass and composition (fat mass, percent fat, fat-free mass, skeletal muscle mass, and body water) using bioelectrical impedance analysis, body image scanning, and neck, waist, and hip circumference measurements. If available, at 1-2 Army bases, dual x-ray absorptiometry (DXA) will be used.
Gut microbiome composition Measured one time at visit 1 (within 1-2 weeks of study enrollment). Measured in stool
Albumin, iodine, and other biomarkers of health Measured one time at visit 1 (within 1-2 weeks of study enrollment). Measured in urine
Prescription and over-the-counter medication and supplement use The information on current use of medications and dietary supplements will be obtained one time at visit 1 (within 1-2 weeks of study enrollment). ASA24® data will be collected at visit 1 and again 3-10 days later Volunteers will be asked the name of each supplement and medication used in the past 30 days and the dose, unit, frequency, route, indication, and start/stop date. An opaque bag will be provided to volunteers to transport supplements to the in-person visit. Dietary supplement use will also be assessed by ASA24® in conjunction with the 24-hour dietary recall.
Trial Locations
- Locations (3)
Fort Campbell
🇺🇸Fort Campbell North, Kentucky, United States
Fort Johnson
🇺🇸Leesville, Louisiana, United States
Pennington Biomedical Research Center
🇺🇸Baton Rouge, Louisiana, United States