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Physical Activity Intervention for Cardiovascular Risk

N/A
Recruiting
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
At least one of the following common cardiometabolic risk factors: high blood pressure:> 129 mm hg SP or >89 mm hg DP or medication, high fasting glucose:>100 mg/dl or high HbA1c: ≥42 mmols/mol or medication, overweight/ obesity: BMI ≥25 kg/m2
overweight/ obesity: BMI ≥25 kg/m2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week recording; measured at baseline, 6 and 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I have high blood pressure, high blood sugar, or I am overweight.
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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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I am between 40 and 70 years old.
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My blood sugar or HbA1c levels are high, or I am on medication for it.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Step counts at 12 months
Change from baseline in meeting the aerobic activity goal at 12 months
Secondary outcome measures
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

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
1,716 Previous Clinical Trials
16,346,400 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,703 Total Patients Enrolled
Bonny Rockette-Wagner, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
79 Total Patients Enrolled

Media Library

ActiveGOALSv2 Clinical Trial Eligibility Overview. Trial Name: NCT04743856 — N/A
High Blood Pressure Research Study Groups: PAT (Physical activity monitor), ActiveGOALSv2
High Blood Pressure Clinical Trial 2023: ActiveGOALSv2 Highlights & Side Effects. Trial Name: NCT04743856 — N/A
ActiveGOALSv2 2023 Treatment Timeline for Medical Study. Trial Name: NCT04743856 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor presently recruiting participants?

"Clinicaltrials.gov shows that this medical trial is currently recruiting participants, having first been posted on March 29th 2022 and modified as recently as April 8th of the same year."

Answered by AI

What beneficial results are expected to be achieved by this clinical trial?

"The primary endpoint of this clinical trial, monitored over a period of 12 months compared to the baseline measurement, is Change from Baseline in Step Counts at 12 Months. Secondary endpoints comprise Blood Pressure taken by clinic staff with an automated cuff after 5 minutes of being seated upright (with three measurements if necessary), Patient Experience Survey created in collaboration with patient partners, and Objectively measured Step Counts via ActiGraph accelerometer."

Answered by AI

How many individuals have been recruited to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov records prove that this medical trial, initially announced on March 29th 2022, is currently seeking participants. Around 54 patients must be enrolled from one distinct medical centre."

Answered by AI

Do I fulfill the requirements to join this experiment?

"This research requires 54 participants to meet the criteria of being within the ages 40-70 and having obesity."

Answered by AI

Does this research program accept participants aged 75 or above?

"This clinical trial has set 40 years old as the lower limit and 70 years old as the upper boundary for patient recruitment, in accordance with its inclusion criteria."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~4 spots leftby May 2024