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Clinical Trial NCT05285748 for Physical Inactivity is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults

Active, not recruiting
Clinical Trial NCT05285748 is designed to study Prevention for Physical Inactivity. It is a Phase 2 interventional trial that is active, not recruiting, having started on 15 March 2022, with plans to enroll 258 participants. Led by Brown University, it is expected to complete by 1 May 2026. The latest data from ClinicalTrials.gov was last updated on 29 May 2025.
Brief 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.
Official Title

Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT

Conditions
Physical Inactivity
Other Study IDs
NCT ID Number
NCT05285748
Start Date (Actual)
2022-03-15
Last Update Posted
2025-05-29
Completion Date (Estimated)
2026-05
Enrollment (Estimated)
258
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Physical activity
Exercise
Self-pacing
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSelf-Paced Intensity Physical Activity
Self-paced Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in self-selected intensity PA.
Active ComparatorPrescribed Moderate Intensity Physical Activity
Prescribed Moderate Intensity Physical Activity
Participants are given a prescription to engage in 150-300 minutes per week of structured exercise with an emphasis on walking. For this study arm, participants are given the explicit recommendation to engage in moderate intensity PA consistent with national guidelines.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in total volume of structured PA
Minutes of PA weighted by intensity, expressed in metabolic equivalent (MET) minutes as determined by accelerometers (Actigraph \[model wGT3x-BT\]) worn during one-week periods.
Measured at baseline, and months 3, 6, 9, and 12.
Minutes per week of PA
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Changes in Body Weight
Assessment of self-reported body weight by study-provided scales
Measured at baseline, and months 3, 6, 9, and 12.
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
50 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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

  • 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

Brown University logoBrown University116 active trials to explore
National Institute on Aging (NIA) logoNational Institute on Aging (NIA)
Study Responsible Party
David M. Williams, Principal Investigator, Professor, Brown University
No contact data.
1 Study Locations in 1 Countries

Rhode Island

Brown University, Providence, Rhode Island, 02912, United States