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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active-duty Army Service Members | All measures will be collected one time during the study, except for the dietary recall (measured two times) and urine sample for total daily energy expenditure using doubly labeled water method (measured 3 time). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Anxiety |
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Inclusion Criteria:
Exclusion Criteria:
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Active-duty U.S. Army Soldiers (n=600 completers)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire E Berryman, PhD, RD | Contact | (225) 763-3010 | Claire.Berryman@pbrc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Claire E Berryman, PhD, RD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fort Campbell | Recruiting | Fort Campbell | Kentucky | 42223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33980120 | Background | Karl JP, Margolis LM, Fallowfield JL, Child RB, Martin NM, McClung JP. Military nutrition research: Contemporary issues, state of the science and future directions. Eur J Sport Sci. 2022 Jan;22(1):87-98. doi: 10.1080/17461391.2021.1930192. Epub 2021 Jun 3. | |
| 26506192 | Background | Nindl BC, Jaffin DP, Dretsch MN, Cheuvront SN, Wesensten NJ, Kent ML, Grunberg NE, Pierce JR, Barry ES, Scott JM, Young AJ, O'Connor FG, Deuster PA. Human Performance Optimization Metrics: Consensus Findings, Gaps, and Recommendations for Future Research. J Strength Cond Res. 2015 Nov;29 Suppl 11:S221-45. doi: 10.1519/JSC.0000000000001114. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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Whole blood, plasma, serum, urine, and stool samples
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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| Albumin, iodine, and other biomarkers of health | Measured in urine | Measured one time at visit 1 (within 1-2 weeks of study enrollment). |
| Gut microbiome composition | Measured in stool | Measured one time at visit 1 (within 1-2 weeks of study enrollment). |
| 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 |
| 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). |
| Heart rate variability (HRV) | Heart rate variations will be continuously recorded for 10 minutes with the Zephyr Bioharnessâ„¢ (Zephyr Technology Corporation, Annapolis, MD, US). | Measured one time at visit 1 (within 1-2 weeks of study enrollment). |
| Genomics | Array-based genotyping using blood samples | Measured one time at visit 1 (within 1-2 weeks of study enrollment). |
| Hemoglobin mass and blood volume | Hemoglobin mass (Hbmass) will be determined in a subset of participants using the automated CO-rebreathing method. The method is based on the dilution principle where a small volume of tracer (CO) is administered and the subsequent concentration of carboxyhemoglobin (COHb) in the blood allows for calculation of Hbmass. | Measured one time at visit 1 (within 1-2 weeks of study enrollment). |
| Total daily energy expenditure (TDEE) | Total daily energy expenditure will be assessed by the Doubly Labeled Water (DLW) method. Prior to dosing, volunteers will provide a urine sample that will be used to measure background isotope enrichment. Urine will be collected at 4.5 h and 7 d after dosing. Isotopic elimination rates will be calculated to get the rate of CO2 production. Energy expenditure will be calculated by multiplying the rate of CO2 production by an assumed food quotient of the diet. | Measured three times, twice at visit 1 (within 1-2 weeks of study enrollment) and third time at day 7. |
| Psychomotor Vigilance Test (PVT) | This is a 5-min test of simple visual reaction time widely used to assess alertness. The test requires volunteers to sustain attention and respond to stimuli presented at random intervals on a computer screen by pressing a button. Parameters recorded include reaction time, premature responses, correct responses, and number of lapses. | Test will be administered one time at visit 1 (within 1-2 weeks of study enrollment). |
| Pennington Biomedical Research Center | Recruiting | Baton Rouge | Louisiana | 70808 | United States |
|
| Fort Johnson | Recruiting | Leesville | Louisiana | 71459 | United States |
|
| 33396252 | Background | Rittenhouse M, Scott J, Deuster P. Healthy Eating Index and Nutrition Biomarkers among Army Soldiers and Civilian Control Group Indicate an Intervention Is Necessary to Raise Omega-3 Index and Vitamin D and Improve Diet Quality. Nutrients. 2020 Dec 31;13(1):122. doi: 10.3390/nu13010122. |
| 24806489 | Background | Eilerman PA, Herzog CM, Luce BK, Chao SY, Walker SM, Zarzabal LA, Carnahan DH. A comparison of obesity prevalence: military health system and United States populations, 2009-2012. Mil Med. 2014 May;179(5):462-70. doi: 10.7205/MILMED-D-13-00430. |
| 35786769 | Background | Clutter CA, Beckman DJ, Wardian JL, Rittel AG, True MW. Are We Missing an Opportunity? Prediabetes in the U.S. Military. Mil Med. 2024 Jan 23;189(1-2):326-331. doi: 10.1093/milmed/usac197. |
| 24005548 | Background | Chao SY, Zarzabal LA, Walker SM, Herzog CM, Eilerman PA, Luce BK, Carnahan DH. Estimating diabetes prevalence in the Military Health System population from 2006 to 2010. Mil Med. 2013 Sep;178(9):986-93. doi: 10.7205/MILMED-D-13-00147. |
| 25562862 | Background | Herzog CM, Chao SY, Eilerman PA, Luce BK, Carnahan DH. Metabolic syndrome in the Military Health System based on electronic health data, 2009-2012. Mil Med. 2015 Jan;180(1):83-90. doi: 10.7205/MILMED-D-14-00039. |
| 31164033 | Background | Shrestha A, Ho TE, Vie LL, Labarthe DR, Scheier LM, Lester PB, Seligman MEP. Comparison of Cardiovascular Health Between US Army and Civilians. J Am Heart Assoc. 2019 Jun 18;8(12):e009056. doi: 10.1161/JAHA.118.009056. Epub 2019 Jun 5. |
| 11556941 | Background | Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. |
| 16717171 | Background | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |
| 12964174 | Background | Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. |
| 27170304 | Background | Prins A, Bovin MJ, Smolenski DJ, Marx BP, Kimerling R, Jenkins-Guarnieri MA, Kaloupek DG, Schnurr PP, Kaiser AP, Leyva YE, Tiet QQ. The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5): Development and Evaluation Within a Veteran Primary Care Sample. J Gen Intern Med. 2016 Oct;31(10):1206-11. doi: 10.1007/s11606-016-3703-5. Epub 2016 May 11. |
| Background | Schwarzer, R. and Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON. |
| Background | McNair DM, Lorr M, Droppleman LF. Profile of Mood States Manual. San Diego, CA: Educational and Industrial Testing Service. 1971. |
| Background | US Department of the Army. (2017) Nutrition and Menu Standards for Human Performance Optimization. Army Regulation 40-25. |
| 28599045 | Background | Knapik JJ, Reynolds KL, Hoedebecke KL. Stress Fractures: Etiology, Epidemiology, Diagnosis, Treatment, and Prevention. J Spec Oper Med. 2017 Summer;17(2):120-130. doi: 10.55460/SPMB-1E6L. |
| 31401079 | Background | Farina EK, Thompson LA, Knapik JJ, Pasiakos SM, McClung JP, Lieberman HR. Physical performance, demographic, psychological, and physiological predictors of success in the U.S. Army Special Forces Assessment and Selection course. Physiol Behav. 2019 Oct 15;210:112647. doi: 10.1016/j.physbeh.2019.112647. Epub 2019 Aug 8. |
| 2748771 | Background | Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. |
| 34215517 | Background | Cole RE, Jayne JM, O'Connor K, McGraw SM, Beyl R, DiChiara AJ, Karl JP. Development and Validation of the Military Eating Behavior Survey. J Nutr Educ Behav. 2021 Sep;53(9):798-810. doi: 10.1016/j.jneb.2021.04.467. Epub 2021 Jun 30. |
| 18929686 | Background | Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. |
| 18258622 | Background | Gibson AL, Holmes JC, Desautels RL, Edmonds LB, Nuudi L. Ability of new octapolar bioimpedance spectroscopy analyzers to predict 4-component-model percentage body fat in Hispanic, black, and white adults. Am J Clin Nutr. 2008 Feb;87(2):332-8. doi: 10.1093/ajcn/87.2.332. |
| 21555168 | Background | Ling CH, de Craen AJ, Slagboom PE, Gunn DA, Stokkel MP, Westendorp RG, Maier AB. Accuracy of direct segmental multi-frequency bioimpedance analysis in the assessment of total body and segmental body composition in middle-aged adult population. Clin Nutr. 2011 Oct;30(5):610-5. doi: 10.1016/j.clnu.2011.04.001. Epub 2011 May 8. |
| 15394301 | Background | WEIR JB. New methods for calculating metabolic rate with special reference to protein metabolism. J Physiol. 1949 Aug;109(1-2):1-9. doi: 10.1113/jphysiol.1949.sp004363. No abstract available. |
| 8598068 | Background | Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available. |
| 24054542 | Background | Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6. |
| 33541462 | Background | Knapik JJ, Farina EK, Fulgoni VL, Lieberman HR. Clinically diagnosed iron and iodine deficiencies and disorders in the entire population of US military service members from 1997 to 2015. Public Health Nutr. 2021 Aug;24(11):3187-3195. doi: 10.1017/S1368980021000495. Epub 2021 Feb 5. |
| 34130698 | Background | Knapik JJ, Farina EK, Fulgoni VL 3rd, Lieberman HR. Clinically-diagnosed vitamin deficiencies and disorders in the entire United States military population, 1997-2015. Nutr J. 2021 Jun 15;20(1):55. doi: 10.1186/s12937-021-00708-2. |
| 2790131 | Background | Beal SL. Sample size determination for confidence intervals on the population mean and on the difference between two population means. Biometrics. 1989 Sep;45(3):969-77. |
| Background | Lenth RV. Some Practical Guidelines for Effective Sample Size Determination. American Statistician. 2001;55:187-93. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |