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Prescribed vs Self-Paced Exercise for Sedentary Lifestyle (WTW Trial)

Phase 2
Recruiting
Led By David M Williams, Ph.D.
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 50-64
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline, and months 3, 6, 9, and 12.
Awards & highlights

WTW Trial Summary

This trial will examine whether a self-selected or prescribed moderate intensity physical activity intervention leads to better outcomes in adults aged 50-64.

Who is the study for?
This trial is for sedentary or low-active adults aged 50-64 with a BMI of 25-40. They must have a smartphone compatible with the study app and be able to walk without assistance. Exclusions include recent hospitalizations, heart disease treatments, major surgeries, certain medical conditions that limit exercise ability, psychiatric hospitalization, non-Rhode Island residents or those not fluent in English.Check my eligibility
What is being tested?
The study compares two physical activity programs: one where participants choose their own pace (SELF-PACED) and another with a prescribed moderate intensity (PRESCRIBED). Participants will wear accelerometers and use heart rate monitors to track activity levels over a year, with follow-ups at months 3, 6, 9, and 12.See study design
What are the potential side effects?
Potential side effects from participating in this physical activity program may include general discomforts like muscle soreness or fatigue due to increased activity levels. However specific side effects are not detailed as it largely depends on individual health status.

WTW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 64 years old.

WTW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline, and months 3, 6, 9, and 12.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline, and months 3, 6, 9, and 12. 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 in total volume of structured PA
Minutes per week of PA
Secondary outcome measures
Changes in Body Weight
Other outcome measures
12 Item Short Form (SF-12) Health Survey
Activity Tracker Use Questionnaire
Attitude towards Physical Activity - Affective Attitude Questionnaire
+20 more

WTW Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Self-Paced Intensity Physical ActivityExperimental Treatment1 Intervention
Group II: Prescribed Moderate Intensity Physical ActivityActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
562,841 Total Patients Enrolled
1 Trials studying Sedentary Lifestyle
232 Patients Enrolled for Sedentary Lifestyle
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,824 Total Patients Enrolled
19 Trials studying Sedentary Lifestyle
4,202 Patients Enrolled for Sedentary Lifestyle
David M Williams, Ph.D.Principal InvestigatorBrown University School of Public Health
2 Previous Clinical Trials
389 Total Patients Enrolled

Media Library

Prescribed Moderate Intensity Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT05285748 — Phase 2
Sedentary Lifestyle Research Study Groups: Prescribed Moderate Intensity Physical Activity, Self-Paced Intensity Physical Activity
Sedentary Lifestyle Clinical Trial 2023: Prescribed Moderate Intensity Physical Activity Highlights & Side Effects. Trial Name: NCT05285748 — Phase 2
Prescribed Moderate Intensity Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05285748 — Phase 2

Frequently Asked Questions

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

Does this research project require that participants be over the age of 65?

"This specific clinical trial is only for patients aged 50 to 64. However, there are 9 other trials for patients under 18 and 48 trials for patients over 65 years old."

Answered by AI

How many volunteers are needed for this clinical research project?

"That is correct. The listing on clinicaltrials.gov says that the trial is currently looking for subjects. This experiment was originally posted on March 15th, 2022 and updated July 18th, 2022. They are seeking a total of 240 individuals from 1 location."

Answered by AI

Which type of patient does this research require?

"To be eligible for this trial, patients must meet the following requirements: they must fall between the ages of 50-64, have a BMI of 25-40, be considered sedentary or low active (defined as participating in less than 60 minutes per week of structured exercise), own a smartphone that can connect to the internet at least once every few days, and have a phone that is compatible with the smartphone app."

Answered by AI

Has the FDA looked into self-paced intensity physical activity as a form of exercise?

"Self-Paced Intensity Physical Activity has only been studied in Phase 2 trials, so there is some data indicating it is safe but no efficacy data. Our team at Power estimates the safety to be a 2."

Answered by AI

Are participants still being sought for this experiment?

"Yes, as indicated by the clinicaltrials.gov listing, this trial is still recruiting participants. The study was originally posted on March 15th, 2022 and updated on July 18th, 2022. They are looking for a total of 240 patients at 1 medical site."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
Brown University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~118 spots leftby May 2026