RECRUITING

Vitalis Cardio Pilot

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-19
Study Completion:2025-09-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07001774

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female adults between 18 and 80 years old
  2. * 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)
  3. * Physically able to become more active
  4. * Own a smartphone with a data plan
  5. * Able to understand English and provide informed consent Report intentions to improve either physical activity, eating, or sleep behaviors Requesting a health coach
  1. * • Unable to become more active
  2. * Does not own a smartphone with a data plan
  3. * Inability to read, complete or sign the consent form and survey
  4. * 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

Contacts and Locations

Study Contact

Lucas J Carr, PhD
CONTACT
319-353-5432
lucas-carr@uiowa.edu

Study Locations (Sites)

University of Iowa
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: Lucas Carr

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19
Study Completion Date2025-09-19

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2025-09-19

Terms related to this study

Keywords Provided by Researchers

  • health coaching
  • cardiovascular disease

Additional Relevant MeSH Terms

  • Cardiovascular Disease Risk Factor