NCT07001774

Vitalis Cardio Pilot

Vitalis Cardio Pilot Study: A Single Arm Efficacy Study of a Clinical Health Coaching Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Lucas Carr · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to evaluate the efficacy and feasibility of a 12-week behavioral counseling intervention that has been integrated into the primary care setting on psychosocial, behavioral, and health outcomes in a large sample of adults with at least one CVD risk factor. Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor. H1: We hypothesize participants will improve their behavioral regulation skills and habit formation skills over 12 weeks. Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor. H2: We hypothesize participants will improve PA (daily steps), diet (total daily kilocalories), and sleep (sleep time, sleep efficiency) over the 12-week intervention. Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor. H3: We hypothesize participants will improve blood pressure, weight, waist circumference, body composition, quality of life over the 12-week intervention.

Detailed description

The U.S. Preventive Services Task Force (USPSTF) issued a Grade B level recommendation (moderate net benefit) that healthcare providers offer PA and dietary behavioral counseling interventions to adults with known CVD risk factors. Unfortunately, these types of programs are rarely implemented in the healthcare setting. Consistent with the USPSTF recommendations, the American College of Sports Medicine's Exercise is Medicine (EIM) initiative has called for PA to be integrated into healthcare by screening all patients for inactivity and providing inactive patients with behavioral counseling resources. Our team has established an evidence-based EIM program that screens patients for inactivity and connects them to a behavioral counseling program. In November 2018, Family Medicine well-visit patients started receiving screening for inactivity using the two-item Exercise Vital Sign (EVS) questionnaire. In 2021, the first Health Coaching training program was developed in the state of Iowa that is recognized by the National Board for Health and Wellness Coaching (NBHWC). In June 2023, a new clinical workflow was launched in the university electronic medical record system (Epic) which streamlines the process of connecting inactive Family Medicine patients with local health coaches. This study will test the efficacy of a behavioral counseling program on targeted health behaviors and cardiometabolic risk factors among a sample of adults who are at increased risk for cardiovascular disease. Patients being treated in the Family Medicine clinic who report wanting to meet with a health coach will be provided a link to an online Health Coach Request form in their After Visit Summary report and MyChart accounts. Patients who choose to open and complete the online Health Coach Request form provide their contact information in the form. Interested patients will be contacted via email to gauge their interest and eligibility. Eligible patients will be enrolled into a 12 week intervention that includes meeting with a student health coach 5 times over 12 weeks, wearing an activity monitor daily, and watching two health education videos. Aim 1: Evaluate the efficacy of a 12-week behavioral counseling intervention on psychosocial outcomes of adults with at least one CVD risk factor. Aim 2: Evaluate the efficacy of a 12-week behavioral counseling intervention on behavioral outcomes (physical activity, diet, and sleep) of adults with at least one CVD risk factor. Aim 3: Evaluate the efficacy of a 12-week behavioral counseling intervention on health outcomes (blood pressure, weight, waist circumference, body composition, quality of life) of adults with at least one CVD risk factor.

Conditions

• Cardiovascular Disease Risk Factor

Interventions

Type	Name	Description
BEHAVIORAL	Vitalis Cardio	Participants receive five free health coaching sessions with a trained student health coach, access to two health education videos, and a free wrist worn activity monitor to keep track of their physical activity and sleep behaviors.

Timeline

• Start date: 2023-09-19
• Primary completion: 2025-08-11
• Completion: 2025-08-11
• First posted: 2025-06-03
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States