Physical InactivityPhase 2NCT05285748
Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults
A Phase 2 study testing Self-Paced Intensity Physical Activity and Prescribed Moderate Intensity Physical Activity in people with Physical Inactivity, run by Brown University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Self-Paced Intensity Physical Activity and Prescribed Moderate Intensity Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2022to 31 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT
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.
- Conditions
- Physical Inactivity
- Being tested
- Self-Paced Intensity Physical Activity, Prescribed Moderate Intensity Physical Activity
- Keywords
- Physical activity, Exercise, Self-pacing
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Paced Intensity Physical ActivityBehavioural
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.
Prescribed Moderate Intensity Physical ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Paced Intensity Physical Activity | Experimental | Not described Receives: Behavioral: Self-Paced Intensity Physical Activity |
| Prescribed Moderate Intensity Physical Activity | Active comparator | Not described Receives: Behavioral: Prescribed Moderate Intensity Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Secondary outcomes (1)
Changes in Body Weight
Assessment of self-reported body weight by study-provided scales
Measured: Measured at baseline, and months 3, 6, 9, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Mar 2022
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, David M. Williams, Brown University
- Investigators
- David M Williams, Ph.D., Principal investigator, Brown University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285748
- Sponsor's protocol ID
- R01AG069349
- Other IDs
- F32AG074680
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT
- ClinicalTrials.gov ID
- NCT05285748
- Acronym / sponsor ID
- R01AG069349
- Conditions
- Physical Inactivity
- Keywords
- Physical activity, Exercise, Self-pacing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Paced Intensity Physical Activity | Experimental | Behavioral: Self-Paced Intensity Physical Activity |
| Prescribed Moderate Intensity Physical Activity | Active comparator | Behavioral: Prescribed Moderate Intensity Physical Activity |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (28 listed)
- Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Paced Intensity Physical ActivityParticipants 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. | Behavioural | Self-Paced Intensity Physical Activity |
| Prescribed Moderate Intensity Physical ActivityParticipants 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. | Behavioural | Prescribed Moderate Intensity Physical Activity |
Primary outcome
Change in total volume of structured PA
Time frame: Measured at baseline, and months 3, 6, 9, and 12.
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.
Minutes per week of PA
Time frame: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Participants will be instructed to indicate, in real time, each time they begin and end a PA session via EMA.
1 secondary outcome
Changes in Body Weight
Time frame: Measured at baseline, and months 3, 6, 9, and 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Physical Inactivity
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Promoting Physical Activity in Older Hispanic/Latino(a) Adults
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Individual Variability in Energy Compensation After a 12-Week Supervised Exercise Intervention
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Williams, Ph.D. principal investigator
Brown University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-Paced Intensity Physical Activity and Prescribed Moderate Intensity Physical Activity in people with Physical Inactivity, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total volume of structured PA (time frame: Measured at baseline, and months 3, 6, 9, and 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.