Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Kyla Lara-Breitinger, M.D.
CONTACT
Kyla Lara-Breitinger, M.D.
PRINCIPAL_INVESTIGATOR
Preventive/Vascular Research Team
CONTACT
NCT Number: NCT06053645
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Kyla Lara-Breitinger, M.D.
CONTACT
Kyla Lara-Breitinger, M.D.
PRINCIPAL_INVESTIGATOR
Preventive/Vascular Research Team
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months
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: Baseline, 12 months
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 measured using dual energy X-ray absorptiometry (DEXA).
Time frame: Baseline, 12 months
Measured in millimeters of mercury (mmHg)
Time frame: Baseline, 12 months
Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.
Time frame: Baseline, 12 months
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
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
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
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
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
AI-ECG age is the subject's predicted age based on artificial intelligence analysis of electrocardiograms (ECGs).
Time frame: Baseline, 12 months
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
Peak TR Velocity (m/s) will be measured using transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Time frame: Baseline, 12 months
RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Time frame: Baseline, 12 months
LA volume index (ml/m^2) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Time frame: Baseline, 12 months
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
Average number of arrhythmias identified by an Apple watch worn by subjects for the duration of the study.
Time frame: Baseline, 12 months
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
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
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.
Contact information is provided by the study sponsor or research team.
Kyla Lara-Breitinger, M.D.
CONTACT
Preventive/Vascular Research Team
CONTACT
Mayo Clinic
Other
The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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