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Physical Activity Intervention for Cardiovascular Risk

N/A
Waitlist Available
Led By Bonny Rockette-Wagner, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
overweight/ obesity: BMI ≥25 kg/m2).
Have primary care provider (PCP) permission to increase physical activity without supervision
Must not have
Non-ambulatory or planning a procedure that will lead to not being ambulatory in <12 months
Told by a physician that they have diabetes (other than previous gestational diabetes) or have received a diagnosis of cardiovascular disease, regardless of when
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week recording; measured at baseline, 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a physical activity intervention to see if it increase cardiovascular disease risk in adults. The intervention includes sessions based on social-cognitive theory, coaching, and a physical activity tracker. The investigators hypothesis that the intervention will be more successful than a control group who just receives a physical activity tracker and information on CDC activity recommendations.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this is an exercise-based intervention, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, or injury. However, these are generally mild and manageable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is 25 or higher, indicating I am overweight or obese.
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My doctor agrees I can exercise more on my own.
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I am between 40 and 70 years old.
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I have high blood pressure or I am on medication for it.
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My blood sugar or HbA1c levels are high, or I am on medication for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot walk or will not be able to walk within the next year.
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I have been diagnosed with diabetes or cardiovascular disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week recording; measured at baseline, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week recording; measured at baseline, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Step counts at 12 months
Change from baseline in meeting the aerobic activity goal at 12 months
Secondary study objectives
Blood Pressure over all timepoints for 12 months
Body Weight over all timepoints for 12 months
Fasting Blood Glucose over all timepoints for 12 months
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveGOALSv2Experimental Treatment1 Intervention
Participants will receive the ActiveGOALS online program with an integrated activity tracker.
Group II: PAT (Physical activity monitor)Active Control1 Intervention
Participants will receive a physical activity tracker and encouragement to increase physical activity.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,932 Total Patients Enrolled
7 Trials studying Sedentary Lifestyle
728 Patients Enrolled for Sedentary Lifestyle
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,845 Total Patients Enrolled
5 Trials studying Sedentary Lifestyle
2,473 Patients Enrolled for Sedentary Lifestyle
Bonny Rockette-Wagner, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
79 Total Patients Enrolled
1 Trials studying Sedentary Lifestyle
79 Patients Enrolled for Sedentary Lifestyle

Media Library

ActiveGOALSv2 Clinical Trial Eligibility Overview. Trial Name: NCT04743856 — N/A
Sedentary Lifestyle Research Study Groups: PAT (Physical activity monitor), ActiveGOALSv2
Sedentary Lifestyle Clinical Trial 2023: ActiveGOALSv2 Highlights & Side Effects. Trial Name: NCT04743856 — N/A
ActiveGOALSv2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743856 — N/A
~0 spots leftby Dec 2024
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