The Weight of Cardiovascular Disease

Mayo Clinic60 enrolled

Overview

The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 12 months.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiovascular Diseases Obesity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI ≥30 kg/m2 * At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease * Patients evaluated in the Cardiometabolic clinic * Willingness to complete questionnaires/surveys * Ability to complete monthly self-assessments at home Exclusion Criteria: * BMI \<30 kg/m2 * Pregnancy or lactating women * Hemodynamically unstable CVD * Active malignancy * Autoimmune or systemic inflammatory diseases * Severe renal or hepatic failure * Being considered unsafe to participate as determined by the study physician * Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician * Patients with active psychosis, mania, or substance use disorders

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

Percent body weight loss

Total percent body weight loss will be reported at 12 months based on the following formula: (Starting baseline weight minus current weight) / (starting baseline weight) x 100 equals % of body weight loss.

Time frame: 12 months

Change in Body Mass Index (BMI)

Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703

Time frame: Baseline, 12 months

Change in visceral adiposity distribution

Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).

Time frame: Baseline, 12 months

Secondary Outcomes

Change in Blood Pressure

Measured in millimeters of mercury (mmHg)

Time frame: Baseline, 12 months

Change in point of care glucose

Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.

Time frame: Baseline, 12 months

Change in quality of diet

Change in quality of diet will be assessed by the Mini-EAT (Eating Assessment Tool). The Mini-EAT is a 9 item questionnaire that asks subjects how often they eat different types of foods (e.g. fruits, vegetables, legumes, etc.). Subjects respond on a scale of "I do not eat it at all" to "6 or more servings per day." Higher scores on the Mini-EAT represent a better quality of diet.

Time frame: Baseline, 12 months

Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)

Central Contacts

Preventive/Vascular Research Team

CONTACT

(507) 538-7425 RSTCVRUPREVENT@mayo.edu

Kyla Lara-Breitinger, M.D.

CONTACT

(507) 284-4441 Lara.Kyla@mayo.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Psychosocial distress will be measured by the STOP-D survey. The STOP-D survey asks subjects to rate how often over the last 2 weeks they have felt depressed, anxious, stressed, angry, or lacking social support on a scale of 0-Not at all to 9-Severely. Each item is scored separately without a summed score for overall distress. Higher individual scores on the STOP-D items represent worse psychosocial distress.

Time frame: Baseline, 12 months

Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)

Psychosocial distress will be measured by the IES-R. The IES-R is a questionnaire which asks subjects to rate how distressed or bothered during the past seven days they have been by difficulties that people sometimes have after stressful life events. Responses can range from 0-Not at all to 4-Extremely. Items on the questionnaire are grouped into 3 subscales: Intrusion, Avoidance, and Hyperarousal with scores on each subscale being the mean item response of all items in that group, thus scores for each subscale also range from 0 to 4. Higher scores are indicative of more psychosocial distress following the specific life event of focus.

Time frame: Baseline, 12 months

Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire

Psychosocial distress will be measured by the ACE Questionnaire. The ACE Questionnaire asks subjects various questions regarding life experiences from the first 18 years of life that may be considered adverse experiences (e.g. parental abuse, neglect, parental divorce, etc.). Subjects answer each question with a yes or no selection. The more questions answered yes represents worse psychosocial distress.

Time frame: Baseline, 12 months

Change in functional aerobic capacity (VO2 Max)

VO2 Max is measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) during cardiopulmonary exercise test

Time frame: Baseline, 12 months

Change in artificial intelligence electrocardiogram (AI-ECG) age

AI-ECG age is the subject's predicted age based on artificial intelligence analysis of electrocardiograms (ECGs).

Time frame: Baseline, 12 months

Change in E/e'

E/e' will be measured using transthoracic echocardiography (TTE). It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e') and will be used to assess left ventricular diastolic function.

Time frame: Baseline, 12 months

Change in Peak Tricuspid Regurgitation (TR) Velocity

Peak TR Velocity (m/s) will be measured using transthoracic echocardiography (TTE) to assess left ventricular diastolic function.

Time frame: Baseline, 12 months

Change in Right Atrial (RA) Pressure

RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.

Time frame: Baseline, 12 months

Change in Left Atrial (LA) volume index

LA volume index (ml/m\^2) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.

Time frame: Baseline, 12 months

Change in physical activity

Average number of steps a subject takes daily as collected by an Apple watch worn by subjects for the duration of the study.

Time frame: Baseline, 12 months

Change in heart rate with detection of arrhythmia

Average number of arrhythmias identified by an Apple watch worn by subjects for the duration of the study.

Time frame: Baseline, 12 months

Change in cardio fitness

Fitness level reported as high/above average/below average/low as collected by an Apple watch worn by subjects for the duration of the study.

Time frame: Baseline, 12 months

Change in six-minute walk test

Measurement (meters) of distance a person can walk on flat ground in 6 minutes collected by an Apple watch worn by subjects for the duration of the study.

Time frame: Baseline, 12 months

Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale

The WBIS-M is a 11-item instrument for measuring the extent to which overweight individuals think of themselves in terms of prevalent negative stereotypes about overweight and overweight individuals. Respondents can express their level of agreement on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items 1 and 9 need to be scored reversely. Scores are averaged to create a composite score and higher scores represent greater psychosocial distress.

Time frame: Baseline, 12 months