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

August 28, 2026 updated by: David M. Williams, Brown University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Self-Paced Intensity Physical Activity
Behavioral: 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 Comparator: Prescribed Moderate Intensity Physical Activity
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measured at baseline, and months 3, 6, 9, and 12.
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.
Measured daily from date of randomization for 52 weeks based on participant initiation of exercise

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Body Weight
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Assessment of self-reported body weight by study-provided scales
Measured at baseline, and months 3, 6, 9, and 12.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opportunity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's opportunity to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Capability Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's physical and psychological capability to do regular aerobic physical activity
Measured at baseline, and months 3, 6, 9, and 12.
Exercise Motivation Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's motivation on the days they have made a plan to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Habit of Physical Activity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's habits regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Identity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's personal beliefs regarding exercise
Measured at baseline, and months 3, 6, 9, and 12.
Outcome Expectations for Physical Activity Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about the consequences of exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Affective Attitude Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Attitude towards Physical Activity - Instrumental Attitude Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's beliefs about exercise
Measured at baseline, and months 3, 6, 9, and 12.
Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment
Measured at baseline, and months 3, 6, 9, and 12.
Intention Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's intention to exercise
Measured at baseline, and months 3, 6, 9, and 12.
Chronic Pain Screening Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures how much chronic pain a person had in the past 6 months
Measured at baseline, and months 3, 6, 9, and 12.
Pain Medication Use Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures the medications a person is taking for chronic pain
Measured at baseline, and months 3, 6, 9, and 12.
12 Item Short Form (SF-12) Health Survey
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their health
Measured at baseline, and months 3, 6, 9, and 12.
Quality of Life Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures a person's views about their quality of life and health
Measured at baseline, and months 3, 6, 9, and 12.
Activity Tracker Use Questionnaire
Time Frame: Measured at baseline, and months 3, 6, 9, and 12.
Measures of use of physical activity devices, memberships, and equipment
Measured at baseline, and months 3, 6, 9, and 12.
EMA: Affective response to PA
Time Frame: Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA.
Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
EMA: Perceived autonomy
Time Frame: Measured weekly from date of randomization until the end of the study at week 52
Assesses participant's perceived autonomy over exercise behavior.
Measured weekly from date of randomization until the end of the study at week 52
EMA: Perceived exertion
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Assesses participant's perceived exertion during PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: Behavioral intention
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Assesses degree to which participant intends to engage in PA.
Measured daily from date of randomization until the end of the study at week 52
EMA: PA setting
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Assessed the physical and social setting in which a participant engages in physical activity.
Measured daily from date of randomization until the end of the study at week 52
EMA: Anticipated, remembered, and incidental affect
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels.
Measured daily from date of randomization until the end of the study at week 52
EMA: Self-Efficacy for Physical Activity
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Measures beliefs about capabilities to be physically active
Measured daily from date of randomization until the end of the study at week 52
EMA: Social Support for Exercise
Time Frame: Measured daily from date of randomization until the end of the study at week 52
Measures a person's social support available to help them exercise
Measured daily from date of randomization until the end of the study at week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David M Williams, Ph.D., Brown University School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01AG069349 (U.S. NIH Grant/Contract)
  • F32AG074680 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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