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Adaptive Physical Activity Interventions for Low Physical Activity

N/A

Waitlist Available

Led By Susan Buchholz, PhD

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 to 70

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52

Awards & highlights

Study Summary

This trial seeks to find the best way to get sedentary women active and improve their heart health using 4 treatments.

Who is the study for?

This trial is for sedentary women aged 18-70 who work at the study site, own a smartphone, can speak/read English, and are able to walk. Women with certain types of diabetes may join if cleared by their doctor. It's not for those with high blood pressure, heart/lung disease symptoms or who already take enough steps daily.Check my eligibility

What is being tested?

The study tests which combination of four treatments (activity monitor enhancements, motivational texts/calls, group meetings) works best to increase physical activity and improve heart health in inactive working women using a SMART design.See study design

What are the potential side effects?

Since this trial focuses on increasing physical activity through non-invasive methods like monitoring and communication, side effects are minimal but could include discomfort from wearing the PA monitor or potential stress from lifestyle changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Physical activity-MVPA

Physical activity-Steps

Secondary outcome measures

Cardiovascular health (1)

Cardiovascular health (2)

Cardiovascular health (3)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Step1: Initial TreatmentExperimental Treatment2 Interventions

Participants will be randomly assigned to one of the two initial treatment components: a) enhanced physical activity monitor only (physical activity monitor with goal setting and a physical activity prescription) treatment, or b) enhanced physical activity monitor+ motivational text messaging treatment for 8 weeks (early adoption phase). All participants will be given a physical activity step goal The initial treatment time period is from Weeks 1-8.

Group II: Step 3: MaintenanceExperimental Treatment1 Intervention

At Weeks 35-50 (maintenance phase) all participants in the study return to an enhanced physical activity monitor only treatment component.

Group III: Step 2: Augmented TreatmentExperimental Treatment4 Interventions

At Week 8, it will be determined if a women has met her physical activity step goal. If she has, then she will be classified as a responder, and will continue with the same initial treatment component for weeks 9-34 (later adoption). If a woman has not met her physical activity step goal she will be classified as a non-responder. In addition to the initial treatment component non-responders to initial treatments will be randomly assigned to one of two augmented treatment components: a) personal calls, or b) group meetings for Weeks 9-34 (later adoption phase).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,230 Total Patients Enrolled

University of Illinois at ChicagoOTHER

607 Previous Clinical Trials

1,559,054 Total Patients Enrolled

Michigan State UniversityOTHER

184 Previous Clinical Trials

601,106 Total Patients Enrolled

Media Library

Step 1: PA Monitor Clinical Trial Eligibility Overview. Trial Name: NCT03558828 — N/A

Physical Activity Research Study Groups: Step 3: Maintenance, Step 2: Augmented Treatment, Step1: Initial Treatment

Physical Activity Clinical Trial 2023: Step 1: PA Monitor Highlights & Side Effects. Trial Name: NCT03558828 — N/A

Step 1: PA Monitor 2023 Treatment Timeline for Medical Study. Trial Name: NCT03558828 — N/A

Frequently Asked Questions

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

Are there still openings available to participants of this trial?

"Based on information obtained from clinicaltrials.gov, this research initiative is no longer actively enrolling patients. The trial was initially posted in August 2018 and the latest update was produced at the end of November 2022. Although recruitment has stopped for this study, 113 other medical trials are currently recruiting participants."

Answered by AI

Does this investigation permit my participation?

"This research is recruiting 301 subjects, between ages 18 and 70, who partake in physical activities. The following criteria must be met to qualify: Female employees of the trial site, smartphone owners with SMS capabilities able to receive text messages at a predetermined pace, Type 1 diabetes patients or those suffering from undiagnosed Type 2 diabetes with an A1C ≥ 9.0%, cleared by their healthcare provider if applicable, and no disability hindering walking as determined by the PAR-Q & You assessment tool."

Answered by AI

Is this research initiative open to participants of advanced age?

"The minimum age to enroll in this clinical trial is 18, and the maximum age cap is set at 70 years old."

Answered by AI

What are the fundamental goals of this experiment?

"The primary objective of this study, which will be gauged across a baseline plus change timeline spanning weeks 9-10, 35-36 and 51-52, is to measure physical activity in terms of steps taken. Secondary metrics include cardiovascular health (1) assessed through aerobic fitness via participant step test; body composition as BMI (weight in pounds - height in inches); and waist measurement (in inches)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

2018. "Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03558828.