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

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

Conditions
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Physical Inactivity

Intervention / Treatment
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* Behavioral: Self-Paced Intensity Physical Activity
* Behavioral: Prescribed Moderate Intensity Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Paced Intensity Physical Activity<br> | Behavioral: Self-Paced Intensity Physical Activity<br>* 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.<br>|
| Active Comparator: Prescribed Moderate Intensity Physical Activity<br> | Behavioral: Prescribed Moderate Intensity Physical Activity<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Weight | Assessment of self-reported body weight by study-provided scales | Measured at baseline, and months 3, 6, 9, and 12. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Exercise, Self-pacing