COVID-19 Health Adjustments in Nutrition, General Wellness, and Exercise

NCT07128095 | Recruiting DMC

• 1 other identifier: IU IRB #27124
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out whether the COVID pandemic has affected participants' current physical activity, fitness, blood pressure, sleep, and mental stress to better understand its long-term health effects. To complete this study, participants will visit the Neurovascular Physiology Laboratory (NVPL) at the Indiana University School of Public Health Bloomington two times, requiring a total commitment of about 6 hours. Visit 1 involves completing screening questionnaires, a consent document, and additional questionnaires about participant health behaviors (e.g., sleep and physical activity) and general mental and physical health. After the visit, participants will also start tracking their sleep and physical activity using wearable devices for 14 days, diet for at least 3 days, and blood pressure and urine for 24 hours. Visit 2 is a second data collection visit, where participants will return the wearable devices. The investigators will measure participants' body composition, take measures of their cardiovascular health, and participants will complete a fitness test on a stationary cycle (exercise bike). The investigators will collect a 24 hour urine sample and take a blood sample to measure participants' blood glucose, electrolytes, hydration biomarkers, and markers of inflammation, as well as to study immune cells. The investigators will take participants' blood pressure at rest and during a hand-in-cold water test, which helps assess how participants' nervous system responds to stress. A full-body scan will measure participant body composition including bone density, muscle mass, and body fat percentage. Finally, participants will complete a cycling test that gradually increases in intensity to measure cardiovascular fitness. Risks involve potential pain or bruising from blood draws, discomfort from blood pressure cuffs, stress from vigorous cycling, and psychological stress from questionnaires. There's also a slight risk of severe cardiovascular events occurring during exercise and loss of data confidentiality. Finally, the cold water test may result in a rare but noted situation where the body's nervous system overreacts to the cold stimulus, leading to a drop in blood pressure and heart rate. Participants will be monitored by trained staff during all procedures to ensure safety.

Conditions

COVID-19; Sleep; Immunization; Infection; Physical Inactivity; Blood Pressure; Diet Habit; Mental Health Wellness 1

Keywords

COVID-19; Sleep; Immunization; Infection; Physical Inactivity; Blood Pressure; Diet Habit; Mental Wellness

Outcome Measures

Primary Outcomes (2)

• Brachial blood pressure

  Seated rachial blood pressure will be measured triplicate after at least 5 minutes of rest using an oscillometric device (Suntech CT 40)

  Through study completion (two-1.5 hour study visits)

• 24-hour ambulatory blood pressure

  Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours after their second study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.

  During the second data collection visit

Secondary Outcomes (5)

• Objective sleep duration

  14 days

• Objective sleep efficiency

  14 days

• Subjective sleep duration

  14 days

• Subjective sleep quality

  14 days

• Diet quality

  Measured at baseline

Other Outcomes (5)

• Perceived stress

  Measured at baseline

• Blood pressure reactivity

  Measured for 3 minutes during the second data collection visit

• Inflammatory markers

  Measured during the second data collection visit

Study Arms (1)

CHANGE participants

Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Younger than 18 or older than 75. Have a resting blood pressure \> 150/90. Have a BMI \> 35 Kg/m2 or \< 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular). Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis). Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.

You may qualify if:

• Male and female participants. Are between the ages of 18-75. Have a resting blood pressure no higher than 150/90 (stage 2 hypertension). Have a BMI below 35 kg/m2 (otherwise healthy). Free from metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
• Do not have any precluding medical issues that prevent participants from exercising (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis) or giving blood (e.g., blood thinners).

You may not qualify if:

• Younger than 18 or older than 30. Have a resting blood pressure \> 150/90. Have a BMI \> 35 Kg/m2 or \< 18 Kg/m2. History of metabolic disease (diabetes or renal disease), pulmonary disorders (e.g., COPD, severe asthma, and cystic fibrosis), and cardiovascular disease (peripheral vascular, cardiac, or cerebrovascular).
• Medical issues that prevent safe exercise (i.e., cardiovascular issues, or muscle/joint issues including painful arthritis).
• Medical issues that prevent giving blood (e.g., blood thinners). Currently pregnant.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University School of Public Health

Bloomington, Indiana, 47405, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

During experimental visits, a blood draw will take place to assess changes in plasma electrolyte concentration, osmolality, hemoglobin, and hematocrit, and coded samples will be stored for future inflammation measures (e.g., CRP and IL-6) in addition to isolating peripheral blood mononuclear cells (PBMCs) for studying immune cell phenotype. Participants will also be provided with a urine collection container and corresponding form so that they can collect 24 hours of urine to enable the investigators to assess hydration biomarkers and 24-hour electrolyte (sodium, potassium, chloride) excretion, which is also used to assess dietary electrolyte intake to complement food and fluid diaries.

MeSH Terms

Conditions

COVID-19; Infections; Sedentary Behavior; Feeding Behavior

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior; Behavior, Animal

Study Officials

• Austin T Robinson, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofia Sanchez

CONTACT

8126226405; sofosanc@iu.edu

Jake Muma

CONTACT

8126226405; jmuma@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 2 years after completion of the study, indefinitely
• Access Criteria: Unidentified individual participant data will be made available to other researchers upon reasonable request and data and completion of a material transfer agreement with Indiana University.

Locations

US (1)