Sedentary LifestyleNCT03412084
A "Stand Up and Move More" Intervention for Older Adults
A study testing Stand up and move more in people with Sedentary Lifestyle, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities. Read more about this study
- Who is it for?
- Ages 56 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Stand up and move more
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2018to 1 Dec 2019
- 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 56 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults older than 55 yrs of age
- inactive or low active (i.e., less than 60 minutes of physical activity/week)
- residents of Dane, Iowa, Rock or Vilas counties, and
- residing in a home or an apartment.
Who cannot join
- low levels of sedentary behavior (less than or equal to 6 hours/day),
- recent hospitalization (i.e., past month),
- uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
- inability to stand up without assistance of another person, and
- inability to speak or hear spoken English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translating a "Stand Up and Move More" Intervention by State Aging Units to Older Adults in Underserved Communities
The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.
Read the detailed description
Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).
- Conditions
- Sedentary Lifestyle
- Being tested
- Stand up and move more
- Keywords
- Sedentary Lifestyle, physical function
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand up and move moreBehavioural
4 week behavioral intervention involving the development and implementation of action plans
| Study group | Role | What they receive |
|---|---|---|
| Stand up intervention | Experimental | four week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting Receives: Behavioral: Stand up and move more |
| Control | No intervention | No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sedentary Time Per Day
Participants wore monitors during the day to assess total sitting time/day
Measured: Baseline, 4 weeks, 12 weeks
Secondary outcomes (1)
Short Physical Performance Battery (SPPB) Score
The SPPB is an assessment of physical limitations. It combines scores from a balance test, gait speed test, and a chair stand test. The total possible range of scores is 1-12, higher scores indicate better function/less functional limitations.
Measured: Baseline, 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start14 Mar 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
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 Wisconsin, MadisonThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kelli Koltyn, PhD, Principal investigator, UW-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412084
- Sponsor's protocol ID
- 2013-1155
- Other IDs
- R21AG054916, A176000, EDUC/KINESIOLOGY/KINESIO
- Status last verified
- Nov 2020
- First submitted
- 19 Jan 2018
- Last updated
- 16 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating a "Stand Up and Move More" Intervention by State Aging Units to Older Adults in Underserved Communities
- ClinicalTrials.gov ID
- NCT03412084
- Acronym / sponsor ID
- 2013-1155
- Conditions
- Sedentary Lifestyle
- Keywords
- Sedentary Lifestyle, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the expanded study is to examine the effectiveness of a "Stand Up and Move More" intervention to reduce sedentary behavior in older adults from underserved communities.
Detailed description
Based on successful pilot research in Rock County, WI, and the receipt of funding from the National Institutes of Health, the investigators expanded research to additional counties in Wisconsin for a total of four counties (i.e., Dane, Iowa, Rock, and Vilas counties). Sample size will increase and participants will be randomly assigned to the intervention group (Stand Up and Move More group) or a wait-list control group (who receive the intervention after 12 weeks). The Stand Up and Move More intervention/workshop involves sessions once/week for four weeks with a refresher session at 8 weeks. Assessments will be conducted before the intervention/workshop begins, and then again at 4 weeks and 12 weeks. We have added several questionnaires to examine potential mediators of behavior change (e.g., self-efficacy, self-regulation, outcome expectancies).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stand up intervention | Experimental | Behavioral: Stand up and move morefour week behavioral intervention based on self-regulation theory which is designed to facilitate the development of action plans to break up prolonged sitting |
| Control | No intervention | –No behavioral intervention - the control group will go about their daily life, but come in for assessments at the same time points as the intervention group |
Who may qualify
- Ages
- 56 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults older than 55 yrs of age
- inactive or low active (i.e., less than 60 minutes of physical activity/week)
- residents of Dane, Iowa, Rock or Vilas counties, and
- residing in a home or an apartment.
Key exclusion criteria (5 listed)
- low levels of sedentary behavior (less than or equal to 6 hours/day),
- recent hospitalization (i.e., past month),
- uncontrolled medical conditions including: uncontrolled hypertension, heart disease, actively receiving chemotherapy or palliative care for cancer, stage 4 liver disease, end-stage renal or pulmonary disease, severe arthritis or any other orthopedic condition that could be made worse by standing up and moving more;
- inability to stand up without assistance of another person, and
- inability to speak or hear spoken English.
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 |
|---|---|---|
| Stand up and move more4 week behavioral intervention involving the development and implementation of action plans | Behavioural | Stand up intervention |
Primary outcome
Total Sedentary Time Per Day
Time frame: Baseline, 4 weeks, 12 weeks
Participants wore monitors during the day to assess total sitting time/day
1 secondary outcome
Short Physical Performance Battery (SPPB) Score
Time frame: Baseline, 4 weeks, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sedentary Lifestyle
Recruiting
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
Cardiovascular Diseases (CVD), Coronary Disease
RecruitingObservational study
Pregnancy 24/7 Offspring Study
Healthy
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
RecruitingEarly Phase 1
Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Gestational Diabetes, Endothelial Dysfunction
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.
Kelli Koltyn, PhD principal investigator
UW-Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand up and move more in people with Sedentary Lifestyle, run by University of Wisconsin, Madison 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 4 inclusion and 5 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 16 Dec 2020. 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 16 Dec 2020). 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?
Total Sedentary Time Per Day (time frame: Baseline, 4 weeks, 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 16 Dec 2020.