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

54 Participants Needed

Trial Summary

What is the purpose of this trial?

The main aim of this effort is to test a physical activity intervention, for adult clinical care patients at risk of developing cardiovascular disease. The intervention includes social-cognitive theory-based sessions, remote coaching, a body worn physical activity tracker (PAT), and is delivered online over one year. The investigators hypothesis that this intervention will be more successful at increasing physical activity (defined as objectively measured step counts and % of individuals meeting the moderate-vigorous physical activity goal) as an active control group who receives a body worn PAT and information on the CDC activity recommendations. The proposed intervention will be aligned with efforts by the US Centers for Disease Control to increase population physical activity levels and the American College of Sports Medicine (ACSM) to increase physical activity prescription in primary care.

Research Team

Bonny Rockette-Wagner, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

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

Able to read English at a 6th grade level

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

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

Treatment Details

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.

Participant Groups

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+