Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

  • STATUS
    Recruiting
  • End date
    May 27, 2026
  • participants needed
    240
  • sponsor
    Brown University
Updated on 4 October 2022
Accepts healthy volunteers

Summary

We will randomly assign (blocked on Gender (female, male, other), body mass index (BMI; overweight [25 < BMI < 30]) or obese (30 < BMI <40) and pain status (chronic pain vs not)) adults ages 50-64 into either; (a) self-selected intensity (i.e., SELF-PACED) or (b) prescribed moderate intensity (i.e., PRESCRIBED) conditions. Prior to randomization, persons responding to our ads will participate in the following: (1) telephone screening with the study research assistant (RA) to establish eligibility; (2) an orientation session to obtain more information about the study; and, after providing informed consent (3) baseline assessment and screening (bodyweight, maximal fitness test, dietary intake, and questionnaires to assess potential covariates). Prior to randomization, the RA will give participants an accelerometer to assess baseline physical activity (PA) behavior over a one-week period. Participants will then be randomized to one of the two study conditions. Following randomization, all participants will receive our theory-based PA promotion intervention to help them overcome barriers to regular PA. All participants will be given chest strap heart rate (HR) monitors and instructions on wrist palpation. Follow-up assessments will consist of accelerometry for one-week periods at months 3, 6, 9, and 12, ecological momentary assessment (EMA) throughout the 12 months and bodyweight at 3-month intervals.

Details
Condition Physical Inactivity
Treatment Self-Paced Intensity Physical Activity, Prescribed Moderate Intensity Physical Activity
Clinical Study IdentifierNCT05285748
SponsorBrown University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ages 50-64
BMI 25-40
Sedentary or low-active, defined as participating in < 60 min/week of structured exercise
Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app

Exclusion Criteria

Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below)
Past 3-month overnight hospitalization
Past 3-month treatment for heart disease, including bypass or valve surgery, interventional procedure(s) such as angioplasty (stent), or a pacemaker or other implanted device to control your heart rate or rhythm
Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
Past 6-month seizure
Past 6-month overnight hospitalization due to respiratory disease
Past 6-month lightheadedness, vertigo, dizziness, or fainting
Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
Takes insulin and/or medication that affects the secretion of insulin
Exercise-induced asthma that prevents brisk walking
Takes anticonvulsant medication or medication to treat/control seizures
Diagnosed with cystic fibrosis
Bone or joint problems that make you unable to walk for at least 30 minutes
Physician has said not to exercise because of bone or joint problems
Physician has said a hip or knee replacement will be needed in the next 12 months
Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes
Currently taking or planning on taking medications that affect HR, such as beta or
calcium channel blockers or digoxin, as HR will be used to determine the
moderate intensity range for participants assigned to that condition
Past 12-month overnight psychiatric hospitalization
Currently pregnant or planning to become pregnant in the next year
Currently participating in any exercise or weight-loss research studies
Household member is participating in this study
Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
Unable to receive materials in the mail at residential mailing address
Does not plan to live in Rhode Island for the next 12 months
Unable to speak, read, and/or write fluently in English
Smokers will be eligible, but smoking status will be included as a covariate in analyses
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note