Vitalis Cardio Pilot
Completed · Not applicable
Conditions studied: Cardiovascular Disease Risk Factor
In brief
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.
Key facts
- Study ID
- NCT07001774
- Run by
- Lucas Carr
- People needed
- 120
- Starts
- 2023-09-19
- Expected to finish
- 2025-08-11
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.