Physical Activity Intervention for Cardiovascular Risk

Overseen By Bonny Rockette-Wagner, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Diabetes, Cardiovascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 19

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an online physical activity program, ActiveGOALSv2, might help people at risk of heart disease become more active. Participants will either join a program with online coaching and an activity tracker or receive only the tracker with general guidelines. The researchers aim to determine if the guided program increases daily activity more effectively than using just a tracker. This trial suits adults who exercise infrequently, have high blood pressure or high blood sugar, or are overweight, and who have a doctor’s approval to increase activity. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance heart health strategies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical activity intervention is safe for cardiovascular risk patients?

Research shows that increased activity can reduce the risk of heart disease. One study linked more exercise to a gradual decrease in the risk of dying from any cause, including heart disease. This indicates that exercise is generally safe and beneficial for heart health.

The ActiveGOALSv2 program uses an activity tracker and online coaching to encourage more movement. Past studies with similar programs have not identified any serious safety issues. Participants typically handle these programs well, often experiencing improved well-being and reduced heart disease risk.

Overall, evidence suggests that ActiveGOALSv2 is safe for most people. As always, consulting a healthcare provider before starting any new exercise program is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ActiveGOALSv2 because it combines an online program with an integrated activity tracker, offering a more interactive approach to managing cardiovascular risk. Unlike traditional methods that might rely solely on medication or simple lifestyle advice, this treatment actively involves participants by using technology to encourage and monitor physical activity. The integration of an activity tracker helps participants stay motivated and more aware of their progress, potentially leading to better adherence to physical activity guidelines and improved cardiovascular health outcomes.

What evidence suggests that this trial's interventions could be effective for increasing physical activity in patients at risk of cardiovascular disease?

Research shows that increased activity can significantly lower the risk of heart disease. Studies have found that people who regularly engage in activities like walking or playing sports experience fewer heart problems. One study discovered that just 20 minutes of sports activity each week reduced the risk of dying from any cause by 68%. Another study showed improved heart health when people followed personalized exercise programs. In this trial, participants may receive the ActiveGOALSv2 program, which incorporates these findings by offering online coaching and tracking tools to help maintain activity levels and reduce heart risk. Alternatively, participants may be assigned to the PAT arm, where they will receive a physical activity tracker and encouragement to increase physical activity. ^{1 4 6 7 8}

Who Is on the Research Team?

Bonny Rockette-Wagner, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults aged 40-70 with a BMI of 25 or higher, high blood pressure, prediabetes, low physical activity (less than 150 minutes per week), and internet access can join. They need their doctor's okay to exercise unsupervised and must not be pregnant or have had recent physical activity programs.

Inclusion Criteria

I have high blood pressure, high blood sugar, or I am overweight.

Able to read English at a 6th grade level

My BMI is 25 or higher, indicating I am overweight or obese.

Exclusion Criteria

You have been in a program that tracks your physical activity and sets goals in the past year.

I cannot walk or will not be able to walk within the next year.

Pregnant or planning a pregnancy in <12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a physical activity intervention including social-cognitive theory-based sessions, remote coaching, and a body-worn physical activity tracker, delivered online over one year.

12 months

13 weekly sessions, 6 monthly sessions (online)

Follow-up

Participants are monitored for changes in physical activity, cardiometabolic outcomes, and patient experience.

12 months

Assessments at baseline, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• ActiveGOALSv2
• PAT

Trial Overview The trial tests ActiveGOALSv2—a year-long online program with coaching and a wearable tracker—against just using the tracker with CDC exercise info. It aims to see if it better increases steps and moderate-to-vigorous activity in adults at risk for heart disease.

How Is the Trial Designed?

Group I: ActiveGOALSv2 Experimental Treatment 1 Intervention

Participants will receive the ActiveGOALS online program with an integrated activity tracker.

Group II: PAT (Physical activity monitor) Active Control 1 Intervention

Participants will receive a physical activity tracker and encouragement to increase physical activity.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. publichealth.pitt.edu publichealth.pitt.edu/sites/default/files/Epi_in_Action_Booklet-2021.pdf

Epidemiology in Action! - Pitt Public Health The purpose of this internship was to: (1) develop a greater understanding of non-invasive subclinical CVD measures such as carotid ultrasounds ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10557272/

Outcomes of patients with active cancers and pre-existing ... The primary outcome of the study was major adverse cardiovascular events (MACE), including acute stroke, acute heart failure, myocardial infarction, or all- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11057847/

Physical activity, exercise and adverse cardiovascular ... The results showed that the lowest risks for all-cause mortality were seen in participants undertaking at least 20 min/week of sports activity (68% relative ...

4. researchgate.net researchgate.net/figure/Number-of-studies-based-on-predicted-cardiovascular-diseases-outcomes-ASCVD_fig4_382395730

Number of studies based on predicted cardiovascular ... The main outcome was the occurrence of CVD (self-reported physician diagnoses of either heart disease or stroke). The predictors were screened by the Least ...

5. academia.edu academia.edu/4544947/Reduction_in_Cardiovascular_Disease_Risk_Factors_6Month_Results_from_Project_Active

(PDF) Reduction in Cardiovascular Disease Risk Factors The purpose of this paper is to report 6-month results of these interventions on cardiovascular disease (CVD) risk factors among healthy, sedentary, middle-aged ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9061634/

Ten things to know about ten cardiovascular disease risk factors This 2022 update provides summary tables of ten things to know about 10 CVD risk factors and builds upon the foundation of prior annual versions of "Ten things ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020477/

Results of a prospective cardiovascular disease prevention ... A randomized 9-month trial of TLC including diet, exercise, and stress management showed no difference in plaque burden over the course of the study even while ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474012/

Association between change in cardiovascular risk scores and ... We aimed to examine whether 5-year changes in SCORE and ASCVD risk scores are associated with future cardiovascular disease risk.