ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-15
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05285748

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.

Ages Eligible for Study:50 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ages 50-64
  2. * BMI 25-40
  3. * Sedentary or low-active, defined as participating in \< 60 min/week of structured exercise
  4. * Has a smart phone that can connect to the internet at least once every few days and is compatible with smartphone app
  1. * Medical symptoms/conditions that may make unsupervised exercise unsafe (specific exclusion criteria were developed in consultation with a cardiologist and are listed below):
  2. * Past 3-month overnight hospitalization
  3. * 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
  4. * Past 3-month inability to walk without assistance due to stroke, transient ischemic attack (TIA), or neurologic or spinal injury
  5. * Past 6-month angina, chest pain, or chest discomfort either at rest or with exertion/activity
  6. * Past 6-month peripheral vascular disease such as claudication which causes pain in the legs when walking briskly
  7. * Past 6-month seizure
  8. * Past 6-month overnight hospitalization due to respiratory disease
  9. * Past 6-month lightheadedness, vertigo, dizziness, or fainting
  10. * Heart, lung, abdominal, joint, or orthopedic surgeries in the past 12-months, or pending or scheduled in the next 12 months
  11. * Takes insulin and/or medication that affects the secretion of insulin
  12. * Exercise-induced asthma that prevents brisk walking
  13. * Takes anticonvulsant medication or medication to treat/control seizures
  14. * Diagnosed with cystic fibrosis
  15. * Bone or joint problems that make you unable to walk for at least 30 minutes
  16. * Physician has said not to exercise because of bone or joint problems
  17. * Physician has said a hip or knee replacement will be needed in the next 12 months
  18. * Anything other medical symptoms/condition that prevents participant from being physical unable to walk without assistance continuously for 30 minutes
  19. * 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
  20. * Past 12-month overnight psychiatric hospitalization
  21. * Currently pregnant or planning to become pregnant in the next year
  22. * Currently participating in any exercise or weight-loss research studies
  23. * Household member is participating in this study
  24. * Does not have a Rhode Island mailing address OR if only Rhode Island mailing address is a PO box
  25. * Unable to receive materials in the mail at residential mailing address
  26. * Does not plan to live in Rhode Island for the next 12 months
  27. * Unable to speak, read, and/or write fluently in English
  28. * Smokers will be eligible, but smoking status will be included as a covariate in analyses

Contacts and Locations

Principal Investigator

David M Williams, Ph.D.
PRINCIPAL_INVESTIGATOR
Brown University School of Public Health

Study Locations (Sites)

Brown University
Providence, Rhode Island, 02912
United States

Collaborators and Investigators

Sponsor: Brown University

  • David M Williams, Ph.D., PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2022-03-15
Study Completion Date2026-05

Study Record Updates

Study Start Date2022-03-15
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Physical activity
  • Exercise
  • Self-pacing

Additional Relevant MeSH Terms

  • Physical Inactivity