Military Health and Nutrition Examination Study

Hypertension Clinical Trial

— MHANES  

Official title:

Stand Ready: Military Health and Nutrition Examination Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380322
• Other study ID #: PBRC 2023-034
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Pennington Biomedical Research Center
• Contact: Claire E Berryman, PhD, RD
• Phone: (225) 763-3010
• Email: Claire.Berryman[@]pbrc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dyslipidemias
• Hypertension
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dietary intake	24-hour dietary recalls will be collected using ASA24® to measure intake of macronutrients (protein, carbohydrate, and fat) and micronutrients (vitamins and minerals).	This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later
Primary	Dietary quality	24-hour dietary recalls will be collected using ASA24®. Diet quality will be assessed by the healthy eating index (HEI).	This study will collect one ASA24® recall at visit 1 and a second follow-up 24-hour recall 3-10 days later
Secondary	Depression	Depression will be assessed by the Patient Health Questionnaire-9 (PHQ-9).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Anxiety	Anxiety will be assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Resilience	Resilience will be assessed by the Connor-Davidson Resilience Scale (CD-RISC).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Posttraumatic stress disorder	Posttraumatic stress disorder (PTSD) will be assessed by the the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Self-efficacy	Self-efficacy will be assessed by the Generalized Self-Efficacy Scale (GSE).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Mood	Mood state will be assessed by the Profile of Mood States 2 (POMS2) questionnaire.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Physical activity	Physical activity will be measured using the ActiGraph wGT3X-BT wearable device.	ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
Secondary	Physical activity	Physical activity will be assessed by the Physical Activity and Physical Fitness Questionnaire from NHANES.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Physical performance	Participants will self-report their most recent Army Combat Fitness Test (ACFT) results.	Data will be collected one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Physical injuries	A questionnaire on orthopedic injuries will be administered.	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Sleep duration and quality	Sleep duration and quality will be measured using the ActiGraph wGT3X-BT wearable device.	ActiGraphs will be administered 0-7 days after study enrollment and worn continuously for 5-7 days.
Secondary	Sleep duration and quality	Sleep duration and quality will be assessed by using the Pittsburgh Sleep Quality Index (PSQI).	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Eating behavior (Satiety)	Assessed using the Satiety scale derived from the validated Military Eating Behavior Survey (MEBS)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Eating behavior (Fast Eating Rate)	Assessed using the Fast Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Eating behavior (Slow Eating Rate)	Assessed using the Slow Eating Rate scale derived from the validated Military Eating Behavior Survey (MEBS)	Questionnaires will be administered one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Blood pressure	Measured after an overnight (at least 10 hour) fast, blood pressure will be measured with an automated cuff.	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Anthropometric and body composition measures	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.	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Measures of anemia and iron status, nutrient status, hormone status, stress, cardiometabolic health, and inflammation	Measured in blood	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Albumin, iodine, and other biomarkers of health	Measured in urine	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Gut microbiome composition	Measured in stool	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Prescription and over-the-counter medication and supplement use	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.	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
Secondary	Resting metabolic rate (RMR)	Measured by indirect calorimetry (MedGem or BodyGem indirect calorimeter).	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Heart rate variability (HRV)	Heart rate variations will be continuously recorded for 10 minutes with the Zephyr Bioharness™ (Zephyr Technology Corporation, Annapolis, MD, US).	Measured one time at visit 1 (within 1-2 weeks of study enrollment).
Secondary	Genomics	Array-based genotyping using blood samples	Measured one time at visit 1 (within 1-2 weeks of study enrollment).