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

Brown University

Status and phase

Active, not recruiting

Phase 2

Conditions

Physical Inactivity

Treatments

Behavioral: Prescribed Moderate Intensity Physical Activity

Behavioral: Self-Paced Intensity Physical Activity

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05285748

R01AG069349

F32AG074680 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

258 patients

Sex

All

Ages

50 to 64 years old

Volunteers

Accepts Healthy Volunteers

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