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

NCT05285748 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: R01AG069349F32AG074680
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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

Keywords

Physical activity; Exercise; Self-pacing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in Body Weight

  Measured at baseline, and months 3, 6, 9, and 12.

Other Outcomes (23)

• Opportunity Questionnaire

  Measured at baseline, and months 3, 6, 9, and 12.

• Capability Questionnaire

  Measured at baseline, and months 3, 6, 9, and 12.

• Exercise Motivation Questionnaire

  Measured at baseline, and months 3, 6, 9, and 12.

Study Arms (2)

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

Interventions

Self-Paced Intensity Physical Activity 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.

Self-Paced Intensity Physical Activity

Prescribed Moderate Intensity Physical Activity 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.

Prescribed Moderate Intensity Physical Activity

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David M Williams, Ph.D.

  Brown University School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 18, 2022
• Study Start: March 15, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)