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Active, Not Recruiting

NCT Number: NCT05285748

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Physical Inactivity Behavior Motor Activity Sedentary Behavior

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. Habit of Physical Activity Questionnaire

    Time frame: Measured at baseline, and months 3, 6, 9, and 12.

    Measures a person's habits regarding exercise

  5. Physical Activity Identity Questionnaire

    Time frame: Measured at baseline, and months 3, 6, 9, and 12.

    Measures a person's personal beliefs regarding exercise

  6. 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

  7. 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

  8. 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

  9. 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

  10. Intention Questionnaire

    Time frame: Measured at baseline, and months 3, 6, 9, and 12.

    Measures a person's intention to exercise

  11. 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

  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

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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

  23. 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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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