- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07583940
Low Energy Availability and Hypertension in Division I HBCU Athletes (CORE-DI)
Cardiovascular Outcomes and Relative Energy Deficiency in Division I HBCU Athletes: CORE-DI Study
Panoramica dello studio
Stato
Descrizione dettagliata
SPECIFIC AIMS: The International Olympic Committee on Sports Nutrition (IOCSN) recognized low energy availability (LEA), defined as inadequate calorie intake relative to energy expenditure. LEA may be particularly important cardiovascular disease (CVD) risk among minority athlete populations, especially those exposed to poor Social Determinants of Health (SDOH). This includes Black NCAA Division I collegiate athletes (BD1As), who make up 21% of the Division I population and have a 5x higher risk of sudden cardiac death compared to white athletes. Many of the SDOH indicators are alleviated as a Division I athlete (food is available, education support staff, economic stability, etc.). However, many BD1As come from areas described above and have limited awareness of nutritional factors that impact their health. Our pilot data indicate that BD1As with LEA, were over seven times (OR = 7.2) more likely to have hypertension. Further work is required to identify the mechanisms linking LEA to CVD. However, unraveling the mechanism's two gaps in the literature should be addressed: (i) establish whether the association between LEA and CVD risk is measurable; and (ii) determine whether the association between LEA and CVD is modifiable. Filling these gaps will make it possible to identify at-risk athletes and to prescribe strategies to restore energy balance (LEA) and/or directly decrease CVD risk.
Our long-term goal is to develop a practical, scalable, and effective non-pharmacological intervention to decrease LEA as a way to mitigate CVD risk in BD1As. To support this goal, the overall objective of this proposal is to robustly measure the strength of the association between LEA and HBP risk (in a larger cohort) and determine whether SDOH moderates this association. The investigators hypothesize that those identified as LEA will significantly increase CVD risk and therefore propose two specific aims. Aim 1 will test the hypothesis that LEA is positively associated with cardio-femoral pulse wave velocity (cfPWV), a measure of aortic arterial stiffness and the gold-standard biomarker of vascular aging. Aim 2 will test the hypothesis that LEA and cfPWV is moderated by SDOH. While SDOH research among BD1As does not exist, AAs are more likely to be deficient in fruits, vegetables while southern regions consume larger quantities of added fats, fried foods, processed meats, and sugar-sweetened beverages known to negatively impact cardiovascular health.
Completion of this work will help mitigate the empirical understanding that BD1As are >7x more likely to experience HBP and 5x more likely to experience sudden cardiac death.
The proposed longitudinal observational study will recruit a cohort of >120 BD1As aged 18-25 years recruited from various sports that include an equitable male/female population from a large HBCU. Participants will be assessed twice, ~4 months apart contingent on the beginning and end of their respective competitive season. For each assessment, traditional (nutrition) and novel (pulse wave velocity) CVD risk biomarkers will be measured, then questionnaires will collect information on SDOH: (i) built environment/food security (e.g. accessibility to food); (ii) health literacy (e.g.: ability to find/understand, use health related information); (iii) sport nutrition knowledge (e.g. knowledge of energy and nutrients); (iv) discrimination (e.g.: social/community context).
Aim 1. Determine the strength of the association between LEA and increased cfPWV. The strength of the association using a general linear model the investigators hypothesize that LEA will be strongly associated with cfPWV increase across the competitive season. Measuring cfPWV evaluates the velocity of the pulse wave or forward pressure transmitted between the carotid and femoral arteries. Decreased compliance of the aortic artery increases the velocity of the pulse wave and is known as arterial stiffness. Arterial stiffness is significantly associated with CVD risk and all cause death. cfPWV is known as the gold standard to evaluate arterial stiffness. The investigators predict that LEA will increase cfPWV by >1 m/s increasing CVD risk by 14%.
Aim 2. Determine if the association between LEA and cfPWV is moderated by SDOH. The 4 SDOH variables will be added as covariates to the Aim 1 model independently and then in a multivariable model to test the strength of association between variables. Questionnaires will evaluate information related to: (i) built environment/food security by accessing published public demographic information/geomapping; (ii) health literacy skills instrument short form; (iii) sport nutrition knowledge using the athlete diet index; (iv) discrimination with the everyday discrimination scale. Three of the domains are shown to significantly affect health outcomes in AAs while poor sport nutrition knowledge is highly related to eating disorders and physiological dysfunction. The investigators predict that each SDOH will be a significant effect moderator to the LEA/cfPWV association.
Impact. PWV is a highly sensitive and continuous measure of vascular aging and the gold-stand non-invasive biomarker of CVD risk that has never been applied to BD1As. The final product will be an evidence-based reduction intervention to target LEA related CVD risk. Several factors increase the likelihood of high impact: established relationship with college athlete sample pool, and applicability to the larger athletic population, and our multi-disciplinary team and novel approach.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Troy M Purdom, PhD
- Numero di telefono: 13362853552
- Email: tpurdom@ncat.edu
Backup dei contatti dello studio
- Nome: Catherine Bush, PhD
- Numero di telefono: 3363347712
- Email: cmbush@ncat.edu
Luoghi di studio
-
-
North Carolina
-
Greensboro, North Carolina, Stati Uniti, 27411
- Reclutamento
- North Carolina Agricultural & Technical State University
-
Contatto:
- Troy M Purdom, PhD
- Numero di telefono: 3362853552
- Email: tpurdom@ncat.edu
-
Contatto:
- Catherine Bush, PhD, MPH
- Numero di telefono: 336-334-7712
- Email: cmbush@ncat.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
Age: 18-25yrs Sex: Male and Female Training Status/Experience: HBCU Division I collegiate athletes with >3yrs of previous competitive experience
Exclusion Criteria:
- Persons who self-report any known disease, or unknown issue precluding collegiate competitive participation: Excluded
- Those who have any orthopedic injuries, concussions, or conditions which would preclude safe testing: Excluded
- Individuals who are not yet adults <18yrs (e.g.: infants, children, teenagers):
Excluded
- Persons who have a pacemaker: Excluded
- Persons who are pregnant: Excluded
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
Division I HBCU Athletes
Division I athletes with a minimum of >3yrs experience tested once inside the competitive season and once outside of the competitive season beginning January 2026.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Pulse wave velocity (PWV)
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Pulse wave velocity (PWV) will be calculated by dividing the arterial path length by the pulse transit time (PTT) between the brachial and femoral arteries using the Vicorder® AS Testing System (80Beats Medical, Berlin, DE).
Using a custom-built caliper, arterial path length will be calculated as 80% of the straight-line distance between the brachial and femoral artery measurement sites.
To measure PTT, blood pressure cuffs will be simultaneously inflated to a sub-diastolic pressure over a 10-15s period to acquire the foot of the proximal and distal pressure waveforms.
The closest two of three recordings will be averaged.
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
|
Energy availability
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Energy availability (EA) will be calculated as: EA = (EI - TDEE) / FFM, where EI is energy intake (kcal·day-¹), TDEE is total daily energy expenditure (kcal·day-¹), and FFM is fat-free mass (kg).
TDEE will be estimated as the sum of resting metabolic rate (RMR) and activity-related energy expenditure.
RMR (kcal·day-¹) will be measured via indirect calorimetry.
Activity energy expenditure will be quantified using metabolic equivalents (METs), expressed as hours per day and converted to kilocalories.
Energy intake (EI) will be assessed using 3-day nonconsecutive food records (two weekdays, one weekend day) to capture habitual variability while minimizing participant burden.
To reduce reporting bias, records will be collected using dietitian-administered multiple-pass interviews, which improve accuracy relative to unassisted methods.
Dietary data will be analyzed using Nutrition Data System for Research (NDSR; University of Minnesota).
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Social Determinants of Health (SDOH)
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Four SDOH domains (Figure 3) will be assessed via validated questionnaires administered electronically through Qualtrics (Provo UT, USA).
Built Environment/Food Security: using the USDA Food Access Research Atlas each participant's primary residence zip code will be geocoded to classify the food environment as: 1) food desert (low income + low access); 2) low access only; 3) adequate access.
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
|
Health Literacy
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Health Literacy: the 10-item Health Literacy Skills Instrument-Short Form (HLSI-SF) (score range: 0-50, higher scores indicate better health literacy).
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
|
Sport Nutrition Knowledge
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Sport Nutrition Knowledge: the 16-item Athlete Diet Index (ADI) will evaluate knowledge of nutrition.
The summary score ranges between 0 (lowest knowledge) and 100 (highest knowledge).
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
|
Discrimination
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Discrimination: the 9-item Everyday Discrimination Scale will measure the frequency of discriminatory experiences in daily life (e.g., treated with less respect, receiving poorer service).
Scores range from 9-54, with higher scores indicating greater exposure.
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Demographics
Lasso di tempo: Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Age, sex, and race/ethnicity will be recorded using self report questionnaires.
|
Enrollment to the second time point will not exceed 26 weeks. Testing once within the competitive season and once outside the competitive season (off season).
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Geronimus AT, Hicken M, Keene D, Bound J. "Weathering" and age patterns of allostatic load scores among blacks and whites in the United States. Am J Public Health. 2006 May;96(5):826-33. doi: 10.2105/AJPH.2004.060749. Epub 2005 Dec 27.
- Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305.
- 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.
- Snyder E, Cai B, DeMuro C, Morrison MF, Ball W. A New Single-Item Sleep Quality Scale: Results of Psychometric Evaluation in Patients With Chronic Primary Insomnia and Depression. J Clin Sleep Med. 2018 Nov 15;14(11):1849-1857. doi: 10.5664/jcsm.7478.
- Havranek EP, Mujahid MS, Barr DA, Blair IV, Cohen MS, Cruz-Flores S, Davey-Smith G, Dennison-Himmelfarb CR, Lauer MS, Lockwood DW, Rosal M, Yancy CW; American Heart Association Council on Quality of Care and Outcomes Research, Council on Epidemiology and Prevention, Council on Cardiovascular and Stroke Nursing, Council on Lifestyle and Cardiometabolic Health, and Stroke Council. Social Determinants of Risk and Outcomes for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 1;132(9):873-98. doi: 10.1161/CIR.0000000000000228. Epub 2015 Aug 3. No abstract available.
- Stoner L, Kucharska-Newton A, Meyer ML. Cardiometabolic Health and Carotid-Femoral Pulse Wave Velocity in Children: A Systematic Review and Meta-Regression. J Pediatr. 2020 Mar;218:98-105.e3. doi: 10.1016/j.jpeds.2019.10.065. Epub 2019 Dec 4.
- Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):1269-1324. doi: 10.1161/HYP.0000000000000066. Epub 2017 Nov 13. No abstract available.
- Mountjoy M, Ackerman KE, Bailey DM, Burke LM, Constantini N, Hackney AC, Heikura IA, Melin A, Pensgaard AM, Stellingwerff T, Sundgot-Borgen JK, Torstveit MK, Jacobsen AU, Verhagen E, Budgett R, Engebretsen L, Erdener U. 2023 International Olympic Committee's (IOC) consensus statement on Relative Energy Deficiency in Sport (REDs). Br J Sports Med. 2023 Sep;57(17):1073-1097. doi: 10.1136/bjsports-2023-106994.
- Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation. 2024 Feb 20;149(8):e347-e913. doi: 10.1161/CIR.0000000000001209. Epub 2024 Jan 24.
- Bann CM, McCormack LA, Berkman ND, Squiers LB. The Health Literacy Skills Instrument: a 10-item short form. J Health Commun. 2012;17 Suppl 3(Suppl 3):191-202. doi: 10.1080/10810730.2012.718042.
- Capling L, Gifford JA, Beck KL, Flood VM, Halar F, Slater GJ, O'Connor HT. Relative validity and reliability of a novel diet quality assessment tool for athletes: the Athlete Diet Index. Br J Nutr. 2021 Jul 28;126(2):307-319. doi: 10.1017/S000711452000416X. Epub 2020 Oct 20.
- McGreevy C, Barry M, Bennett K, Williams D. Repeatability of the measurement of aortic pulse wave velocity (aPWV) in the clinical assessment of arterial stiffness in community-dwelling older patients using the Vicorder((R)) device. Scand J Clin Lab Invest. 2013;73(4):269-73. doi: 10.3109/00365513.2013.770162. Epub 2013 Apr 2.
- Yang YL, Yang HL, Kusuma JD, Shiao SPK. Validating Accuracy of an Internet-Based Application against USDA Computerized Nutrition Data System for Research on Essential Nutrients among Social-Ethnic Diets for the E-Health Era. Nutrients. 2022 Jul 31;14(15):3168. doi: 10.3390/nu14153168.
- Shim JS, Oh K, Kim HC. Dietary assessment methods in epidemiologic studies. Epidemiol Health. 2014 Jul 22;36:e2014009. doi: 10.4178/epih/e2014009. eCollection 2014.
- Purdom T, Cook M, Colleran H, Stewart P, San Diego L. Low Energy Availability (LEA) and Hypertension in Black Division I Collegiate Athletes: A Novel Pilot Study. Sports (Basel). 2023 Apr 7;11(4):81. doi: 10.3390/sports11040081.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R16HL179144-01 (Sovvenzione/contratto NIH degli Stati Uniti)
- 1R16HL179144 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .