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This study is a randomized trial that will compare the effects of two, 12-week activity interventions on patterns of physical activity, physical health, and quality of life measures in 40 older adults who are able to walk for exercise. One intervention will target 150 minutes per week of home-based moderate exercise (e.g. brisk walking), consistent with current recommendations. The other intervention will target a decrease in time spent in sedentary behaviors (e.g. sitting) of 60 minutes per day. Both interventions will wear an activity armband which will allow them to self-monitor their activity or sedentary behavior in real time using a smartphone. The armband will also provide objective data to an interventionist that will facilitate the intervention. The main outcome will be time spent in moderate exercise.
Specific Aims: This application proposes to randomize community-dwelling, older adults to one of two, 12-week activity interventions that target either increased moderate-to-vigorous physical activity (MVPA) or decreased sedentary behavior (SED). The primary aim of this research is to evaluate the effect of a behavioral intervention targeting decreased SED vs. increased MVPA on objectively monitored activity (minutes of SED and MVPA). The secondary aim is to evaluate the effect of the SED intervention vs. the MVPA intervention on functional and psychosocial outcomes. To the investigators knowledge, this research will provide unique experimental evidence that SED can be altered in an older adult population and will yield key pilot data on the expected effect size for an intervention targeting SED vs. MVPA.
Background: The older adult population is the least active age group in the U.S. by two distinct metrics: a lack of MVPA and a high rate of SED (sitting without any significant exertion). This represents a public health opportunity because engaging in 150 minutes of MVPA is known to improve the risk of morbidity, mortality, and physical function. SED has emerged as a risk factor for adverse outcomes, independent of MVPA, and observational studies indicate that more SED is linked to an increased risk of clinical outcomes (mortality, diabetes, and cardiovascular disease) and worse aging outcomes, e.g. physical function. However, there exists no experimental data comparing interventions to reduce SED vs. increase MVPA in older adults.
Summary of Methods: The investigators propose a 2-arm randomized trial that will target increasing MVPA (Get Active) vs. decreasing SED (Sit Less) among community-dwelling, older adults from the Pepper Center Mobility Registry. The intervention will consist of a combination of in-person (Weeks 1-4, 6, 8, 10) and phone-based (Weeks 5, 7, 9, 11) individual counseling and will utilize the BodyMedia® Fit System (wearable armband with technology interface) to provide real-time feedback on daily MVPA or SED, which can be used by the subjects to self-monitor and by the interventionist to improve adherence. Assessments at baseline and 12 weeks will include objectively monitored minutes of MVPA and SED by a blinded armband, physical function (short physical performance battery, 400 meter walk, grip strength, gait speed), and assessment of subjective MVPA, SED, physical function, and psychosocial outcomes by questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-vigorous activity group | Active Comparator | This group will target achieving the current recommendations for physical activity in older adults. This is 150 minutes of moderate-to-vigorous activity per week. |
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| Reducing sedentary behavior group | Experimental | This group will target a 60 minute per day reduction in sedentary behavior using an objective activity monitor. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reducing sedentary behavior group | Other | This intervention will use individual counseling and the the BodyMedia armband to self-monitor sedentary behavior. The goal will be to decrease time spent in sedentary behavior by 60 minutes each day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Objectively Monitored Sedentary Behavior | Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day. | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Function (Short Physical Performance Battery [SPPB]) | Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bethany Barone Gibbs, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Activity and Weight Management Research Center | Pittsburgh | Pennsylvania | 15261 | United States |
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241 subjects were screened. Of these 190 did not meet inclusion criteria, 13 declined to participate, and 38 were eligible and enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Get Active | Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity |
| FG001 | Sit Less | Targeting 1 hour less of sedentary time per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Get Active | Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity |
| BG001 | Sit Less | Targeting 1 hour less of sedentary time per day |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Objectively Monitored Sedentary Behavior | Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks. This multi-sensor armband will give an estimate of time spent in sedentary behavior over a 1 week period. Sedentary time will be averaged across days and reported as hours per day. | Posted | Least Squares Mean | Standard Error | hours/day | Change from baseline to 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Get Active | Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bethany Barone Gibbs | University of Pittsburgh | 412-383-4002 | bbarone@pitt.edu |
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| ID | Term |
|---|---|
| D057185 | Sedentary Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Moderate-to-vigorous activity group | Other | This group will be administered an individual, behavioral intervention using the BodyMedia armband to self-monitor physical activity. The prescription will be 150 minutes of moderate exercise (e.g. brisk walking) each week. |
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| Change from baseline to 12 weeks |
| Change in Objectively-monitored Moderate-to-vigorous Physical Activity | Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period. | Change from baseline to 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Body Mass Index, continuous | Mean | Standard Deviation | kg/m^2 |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Change in Physical Function (Short Physical Performance Battery [SPPB]) | Physical function will be assessed by the Short Physical Performance Battery including a chair stand test (timed test to stand up and down 5 times without using hands), a 4-meter walk test for gait speed, and a standing balance test. Standard scoring of the SPPB was used where each test contributes up to 4 points x 3 tests and the score can, therefore, range from 0 (worst) to 12 (best). | Posted | Mean | Standard Error | points | Change from baseline to 12 weeks |
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| Secondary | Change in Objectively-monitored Moderate-to-vigorous Physical Activity | Subjects will wear a BodyMedia SenseWearPro armband for 7 days during all waking hours at baseline and 12 weeks (same as for the primary outcome of sedentary behavior). This multi-sensor armband will give an estimate of time spent in moderate-to-vigorous physical activity over a 1 week period. | Posted | Least Squares Mean | Standard Error | bouted minutes/week | Change from baseline to 12 weeks |
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| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Sit Less | Targeting 1 hour less of sedentary time per day | 0 | 19 | 0 | 19 |
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