Vitalis Cardio Pilot

NCT07001774 | Completed

• 1 other identifier: 202308018
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease Risk Factor

Keywords

health coaching; cardiovascular disease

Outcome Measures

Primary Outcomes (2)

• Behavioral Regulation Skills

  Participant's perceived ability to regulate their physical activity, diet, and sleep behaviors using a six item survey that uses a 5 point Likert scale. Scores will range from 6 (low skills) to 30 (high skills).

  From enrollment to 12 weeks

• Habit formation skills

  Habit formation will be measured with a 3 question survey using a 5 point likert scale. Responses will range from 3 (weak habit) to 15 (strong habit).

  From enrollment to 12 weeks

Secondary Outcomes (5)

• Physical activity

  From enrollment to 12 weeks

• Diet behavior

  From enrollment to 12 weeks

• Sleep behavior

  From enrollment to 12 weeks

• Global Health

  From enrollment to 12 weeks

• Weight (lbs)

  From enrollment to 12 weeks

Study Arms (1)

Vitalis Cardio Intervention

EXPERIMENTAL

The intervention includes health coaching, health education, and wearable activity monitoring.

Behavioral: Vitalis Cardio

Interventions

Vitalis Cardio BEHAVIORAL

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.

Vitalis Cardio Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults between 18 and 80 years old
• Report at least one known cardiovascular disease risk factor (high blood pressure (systolic \> 130 or diastolic \> 80), high low-density lipoprotein cholesterol (\>160), diabetes diagnosis, smoking, obesity (BMI\>30.0), or physical inactivity (\<150 minutes/week of moderate intensity physical activity)
• Physically able to become more active
• Own a smartphone with a data plan
• Able to understand English and provide informed consent Report intentions to improve either physical activity, eating, or sleep behaviors Requesting a health coach

You may not qualify if:

• Unable to become more active
• Does not own a smartphone with a data plan
• Inability to read, complete or sign the consent form and survey
• Presence of a psychiatric disorder that is not managed/unstable or suicidal ideation/actuation in preceding 12 months Pregnant or plan to become pregnant in the next 2 months

Sponsors & Collaborators

• Lucas Carr: lead
• Google LLC.: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: June 3, 2025
• Study Start: September 19, 2023
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: February 12, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)