Clinical trial NCT05285748: Comparing Self-paced Versus Moderate Intensity Physical Activity Recommendation for Midlife Adults
Official title: Comparing a Recommendation for Self-paced Versus Moderate Intensity Physical Activity for Midlife Adults: an RCT
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Physical Inactivity
Keywords: Physical activity
Exercise
Self-pacing
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-03-18
Enrollment: 258
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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:

* 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

Primary outcomes:
measure: Change in total volume of structured PA
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Minutes per week of PA
timeFrame: Measured daily from date of randomization for 52 weeks based on participant initiation of exercise
Secondary outcomes:
measure: Changes in Body Weight
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
Other outcomes:
measure: Opportunity Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Capability Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Exercise Motivation Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Habit of Physical Activity Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Physical Activity Identity Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Outcome Expectations for Physical Activity Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Attitude towards Physical Activity - Affective Attitude Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Attitude towards Physical Activity - Instrumental Attitude Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment)
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Intention Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Chronic Pain Screening Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Pain Medication Use Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: 12 Item Short Form (SF-12) Health Survey
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Quality of Life Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: Activity Tracker Use Questionnaire
timeFrame: Measured at baseline, and months 3, 6, 9, and 12.
measure: EMA: Affective response to PA
timeFrame: Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study
measure: EMA: Perceived autonomy
timeFrame: Measured weekly from date of randomization until the end of the study at week 52
measure: EMA: Perceived exertion
timeFrame: Measured daily from date of randomization until the end of the study at week 52
measure: EMA: Behavioral intention
timeFrame: Measured daily from date of randomization until the end of the study at week 52
measure: EMA: PA setting
timeFrame: Measured daily from date of randomization until the end of the study at week 52
measure: EMA: Anticipated, remembered, and incidental affect
timeFrame: Measured daily from date of randomization until the end of the study at week 52
measure: EMA: Self-Efficacy for Physical Activity
timeFrame: Measured daily from date of randomization until the end of the study at week 52
measure: EMA: Social Support for Exercise
timeFrame: Measured daily from date of randomization until the end of the study at week 52
Locations:
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University School of Public Health
name: David M Williams, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: