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

NCT ID: NCT05285748

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2026-05-31

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.

Conditions

Physical Inactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Self-Paced Intensity Physical Activity

Group Type: EXPERIMENTAL

Self-Paced Intensity Physical Activity

Intervention Type: BEHAVIORAL

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 Activity

Group Type: ACTIVE_COMPARATOR

Prescribed Moderate Intensity Physical Activity

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

David M. Williams

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David M Williams, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University School of Public Health

Locations

Brown University

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

F32AG074680

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG069349

Identifier Type: NIH

Identifier Source: org_study_id

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