Sedentary LifestyleRISENCT02146001
Reducing Sedentary Behavior vs. Increasing Physical Activity in Older Adults
A study testing Reducing sedentary behavior group and Moderate-to-vigorous activity group in people with Sedentary Lifestyle, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Reducing sedentary behavior group and Moderate-to-vigorous activity group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥60 years
- Currently engage in <60 minutes of MVPA per week
- Ability to complete a 400 meter walk test without an assistive device
- Access to a computer and compatible smartphone (Andriod or iPhone) for the use of the BodyMedia® Fit System to monitor Moderate -to - Vigorous physical activity or sedentary behavior
- Ability to provide medical clearance to participate in this study from their primary care physician
Who cannot join
- Unable to provide informed consent
- Household member on study staff
- Current or planned enrollment in another physical activity or weight loss program
- Cardiovascular event (heart attack, stroke, heart failure, revascularization procedure) in the last 6 months
- Current use of beta-blockers or other medication that could affect heart rate
- Currently treated for psychological issues, or taking psychotropic medications within the previous 6 months
- Comorbid condition that would limit participation in exercise (e.g. uncontrolled hypertension, severe arthritis, use of a assistive mobility device, currently undergoing treatment for cancer)
- >3 alcoholic beverages per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Weight Management Research Center
Pittsburgh, Pennsylvania, 15261
About this study
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.
Read the detailed description
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.
- Conditions
- Sedentary Lifestyle
- Being tested
- Reducing sedentary behavior group, Moderate-to-vigorous activity group
- Keywords
- sedentary behavior, physical activity, older adults
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing sedentary behavior groupOther
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.
Moderate-to-vigorous activity groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Moderate-to-vigorous activity group |
| Reducing sedentary behavior group | Experimental | This group will target a 60 minute per day reduction in sedentary behavior using an objective activity monitor. Receives: Other: Reducing sedentary behavior group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12 weeks
Secondary outcomes (2)
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).
Measured: 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.
Measured: Change from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethany Barone Gibbs, University of Pittsburgh
- Investigators
- Bethany Barone Gibbs, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146001
- Sponsor's protocol ID
- Pitt Pepper 124078
- Acronym
- RISE
- Status last verified
- Jul 2016
- First submitted
- 3 Mar 2014
- Last updated
- 19 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behavior vs. Increasing Physical Activity in Older Adults
- ClinicalTrials.gov ID
- NCT02146001
- Acronym / sponsor ID
- RISE / Pitt Pepper 124078
- Conditions
- Sedentary Lifestyle
- Keywords
- sedentary behavior, physical activity, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 23 May 2014 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-vigorous activity group | Active comparator | Other: Moderate-to-vigorous activity groupThis group will target achieving the current recommendations for physical activity in older adults. This is 150 minutes of moderate-to-vigorous activity per week. |
| Reducing sedentary behavior group | Experimental | Other: Reducing sedentary behavior groupThis group will target a 60 minute per day reduction in sedentary behavior using an objective activity monitor. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥60 years
- Currently engage in <60 minutes of MVPA per week
- Ability to complete a 400 meter walk test without an assistive device
- Access to a computer and compatible smartphone (Andriod or iPhone) for the use of the BodyMedia® Fit System to monitor Moderate -to - Vigorous physical activity or sedentary behavior
- Ability to provide medical clearance to participate in this study from their primary care physician
Key exclusion criteria (8 listed)
- Unable to provide informed consent
- Household member on study staff
- Current or planned enrollment in another physical activity or weight loss program
- Cardiovascular event (heart attack, stroke, heart failure, revascularization procedure) in the last 6 months
- Current use of beta-blockers or other medication that could affect heart rate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducing sedentary behavior groupThis 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. | Other | Reducing sedentary behavior group |
| Moderate-to-vigorous activity groupThis 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. | Other | Moderate-to-vigorous activity group |
Primary outcome
Change in Objectively Monitored Sedentary Behavior
Time frame: Change from baseline to 12 weeks
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.
2 secondary outcomes
Change in Physical Function (Short Physical Performance Battery [SPPB])
Time frame: Change from baseline to 12 weeks
Change in Objectively-monitored Moderate-to-vigorous Physical Activity
Time frame: Change from baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sedentary Lifestyle
Recruiting
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes
Diabetes Mellitus, Type 2, Lifestyle
Not yet recruitingEarly Phase 1
Kava Aging and Mobility Study
Old Adults, Sleep Quality
Recruiting
Polarized Aerobic Training and Vascular Adaptations in Apparently Healthy Individuals
Sedentary Lifestyle
Recruiting
Families Implementing Good Health Traditions for Life
Diabetes, Chronic Disease
Not yet recruitingObservational study
Effects of Sustainable Exercise Habits in University Students
Sedentary Lifestyle, Physical Activity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethany Barone Gibbs, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing sedentary behavior group and Moderate-to-vigorous activity group in people with Sedentary Lifestyle, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Objectively Monitored Sedentary Behavior (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016; AzTrials last refreshed its copy on 30 Oct 2026.