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| ID | Type | Description | Link |
|---|---|---|---|
| F32AG074680 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Paced Intensity Physical Activity | Experimental |
| |
| Prescribed Moderate Intensity Physical Activity | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opportunity Questionnaire | Measures a person's opportunity to do regular aerobic physical activity | Measured at baseline, and months 3, 6, 9, and 12. |
| Capability Questionnaire | Measures a person's physical and psychological capability to do regular aerobic physical activity |
Inclusion criteria:
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):
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
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| Name | Affiliation | Role |
|---|---|---|
| David M Williams, Ph.D. | Brown University School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 22, 2021 | Feb 22, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 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. |
|
| Measured at baseline, and months 3, 6, 9, and 12. |
| Exercise Motivation Questionnaire | Measures a person's motivation on the days they have made a plan to exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Habit of Physical Activity Questionnaire | Measures a person's habits regarding exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Physical Activity Identity Questionnaire | Measures a person's personal beliefs regarding exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Outcome Expectations for Physical Activity Questionnaire | Measures a person's beliefs about the consequences of exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Attitude towards Physical Activity - Affective Attitude Questionnaire | Measures a person's beliefs about exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Attitude towards Physical Activity - Instrumental Attitude Questionnaire | Measures a person's beliefs about exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Physical Activity Enjoyment Scale (title of questionnaire; not subscale; measuring changes in PA enjoyment) | Measures how much a person enjoys exercise; scores range from 18-26 and higher scores mean more physical activity enjoyment | Measured at baseline, and months 3, 6, 9, and 12. |
| Intention Questionnaire | Measures a person's intention to exercise | Measured at baseline, and months 3, 6, 9, and 12. |
| Chronic Pain Screening Questionnaire | Measures how much chronic pain a person had in the past 6 months | Measured at baseline, and months 3, 6, 9, and 12. |
| Pain Medication Use Questionnaire | Measures the medications a person is taking for chronic pain | Measured at baseline, and months 3, 6, 9, and 12. |
| 12 Item Short Form (SF-12) Health Survey | Measures a person's views about their health | Measured at baseline, and months 3, 6, 9, and 12. |
| Quality of Life Questionnaire | Measures a person's views about their quality of life and health | Measured at baseline, and months 3, 6, 9, and 12. |
| Activity Tracker Use Questionnaire | Measures of use of physical activity devices, memberships, and equipment | Measured at baseline, and months 3, 6, 9, and 12. |
| EMA: Affective response to PA | Captures the shift in core affective valence (feeling good vs bad) from pre-PA to during-PA. | Upon participant initiation of PA session, measured before, during, and after PA sessions; beginning at randomization through 52 weeks of study |
| EMA: Perceived autonomy | Assesses participant's perceived autonomy over exercise behavior. | Measured weekly from date of randomization until the end of the study at week 52 |
| EMA: Perceived exertion | Assesses participant's perceived exertion during PA. | Measured daily from date of randomization until the end of the study at week 52 |
| EMA: Behavioral intention | Assesses degree to which participant intends to engage in PA. | Measured daily from date of randomization until the end of the study at week 52 |
| EMA: PA setting | Assessed the physical and social setting in which a participant engages in physical activity. | Measured daily from date of randomization until the end of the study at week 52 |
| EMA: Anticipated, remembered, and incidental affect | Will assess how participant expects to feel after engaging in PA, how participant remembers feeling after engaging in PA, and how participant currently feels. | Measured daily from date of randomization until the end of the study at week 52 |
| EMA: Self-Efficacy for Physical Activity | Measures beliefs about capabilities to be physically active | Measured daily from date of randomization until the end of the study at week 52 |
| EMA: Social Support for Exercise | Measures a person's social support available to help them exercise | Measured daily from date of randomization until the end of the study at week 52 |