Sedentary LifestyleNCT03473145
Sedentary Behavior Interrupted Randomized Controlled Trial (P2)
A study testing Health Coaching, activPAL inclinometer and Tools to Prompt Standing or Prompt Sit-to-Stand Transitions. in people with Sedentary Lifestyle, run by University of California, San Diego at 1 site in United States.
Trial summary
Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines \& spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, \& the age-associated challenges of meeting traditional PA guidelines, involving… Read more about this study
- Who is it for?
- Ages 55 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- Health Coaching, activPAL inclinometer and Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 407 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 31 Dec 2024
- 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 55 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female;
- 55 years of age and above;
- any ethnicity or race;
- screened to sit for 7 or more hours per day, perform less than 70 sit-to-stand transitions per day
- ambulatory;
- medically stable without any health conditions that would inhibit standing or PA;
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- able to give informed consent \& comply with study protocols;
- able to read and write fluently in English;
- able to travel to study visits; and
- no menstruation for at least one year;
- BMI 25-45
- able to walk, stand and transition without high risk of falling.
Who cannot join
- Male;
- younger than 55 years of age;
- sit for less than 7 hours per day, perform 71 or more sit-to-stand transitions per day
- mental state that would preclude complete understanding of the protocol or compliance;
- physical limitations to completing any of the study conditions;
- menstruation less than one year prior;
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- unable to complete the Short Physical Performance Battery,
- Active cancer
- body Mass Index <25 or >45kg/m2,
- use of insulin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedentary Behavior Interrupted: A Randomized Trial of 3-month Effects on Biomarkers of Healthy Aging and Physical Functioning in the Real World (Project 2)
Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines \& spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, \& the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.
Read the detailed description
Primary Aims:
In our primary biomarker outcomes of glucose regulation (fasting insulin \& glucose, HbA1c, HOMA-IR) \& blood pressure (BP):
- Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.
- Investigate the dose-response effects of behavioral change on the biomarkers \& BP.
Secondary aims
- Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical, emotional \& cognitive functioning.
- Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function.
Exploratory aims
- Explore the possible modifying effect of age on the relationship between intervention conditions \& primary \& secondary outcomes.
- Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time, standing time, and transitions.
- Explore differences in outcomes between the 2 sitting interruption conditions.
- Conditions
- Sedentary Lifestyle
- Being tested
- Health Coaching, activPAL inclinometer, Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention.
activPAL inclinometerDevice
Participants in the intervention study arms (B \& C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan.
Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.Other
Participants in the intervention study arms (B \& C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs.
| Study group | Role | What they receive |
|---|---|---|
| Health Living Attention Control | Active comparator | Participants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. Receives: Behavioral: Health Coaching |
| Reduce Sitting | Experimental | Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. Receives: Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions. |
| Sit-to-Stand Transition | Experimental | Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. Receives: Behavioral: Health Coaching; Device: activPAL inclinometer; Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Regulation (mU/L)
Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
Measured: 3 months
Secondary outcomes (1)
Self-Reported Physical Functioning
Self-reported physical functioning was assessed using the Rand SF 36-Item Health Survey that assesses 8 health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. The range of scores is 0 - 100 with higher scores meaning better physical functioning.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start30 May 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2024
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri Hartman, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473145
- Sponsor's protocol ID
- 1P01AG052352-01A1
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2018
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hartman SJ, LaCroix AZ, Sears DD, Natarajan L, Zablocki RW, Chen R, Patterson JS, Dillon L, Sallis JF, Schenk S, Dunstan DW, Owen N, Rosenberg DE. Impacts of Reducing Sitting Time or Increasing Sit-to-Stand Transitions on Blood Pressure and Glucose Regulation in Postmenopausal Women: Three-Arm Randomized Controlled Trial. Circulation. 2025 Aug 26;152(8):492-504. doi: 10.1161/CIRCULATIONAHA.124.073385. Epub 2025 Jul 25.
PubMed 40709462Zablocki RW, Hartman SJ, Di C, Zou J, Carlson JA, Hibbing PR, Rosenberg DE, Greenwood-Hickman MA, Dillon L, LaCroix AZ, Natarajan L. Using functional principal component analysis (FPCA) to quantify sitting patterns derived from wearable sensors. Int J Behav Nutr Phys Act. 2024 Apr 26;21(1):48. doi: 10.1186/s12966-024-01585-8.
PubMed 38671485Hartman SJ, Dillon LW, LaCroix AZ, Natarajan L, Sears DD, Owen N, Dunstan DW, Sallis JF, Schenk S, Allison M, Takemoto M, Herweck AM, Nguyen B, Rosenberg DE. Interrupting Sitting Time in Postmenopausal Women: Protocol for the Rise for Health Randomized Controlled Trial. JMIR Res Protoc. 2021 May 13;10(5):e28684. doi: 10.2196/28684.
PubMed 33983131
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior Interrupted: A Randomized Trial of 3-month Effects on Biomarkers of Healthy Aging and Physical Functioning in the Real World (Project 2)
- ClinicalTrials.gov ID
- NCT03473145
- Acronym / sponsor ID
- 1P01AG052352-01A1
- Conditions
- Sedentary Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidemiological findings indicate that older adults do not meet physical activity (PA) guidelines \& spend up to 11 hrs/day sitting. Given the high prevalence of sedentary behavior (SB), the higher chronic disease risk in this population, \& the age-associated challenges of meeting traditional PA guidelines, involving longer bouts of moderate PA, the investigators hypothesize that older adult health will benefit from new strategies to interrupt sitting. This protocol "Sedentary Behavior Interrupted: A randomized trial of 3-month effects on biomarkers of healthy aging and physical functioning in the real world (Project 2)" is part of a National Institutes of Aging Program Grant called "Sedentary Time \& Aging Mortality and Physical Function (STAR). The overall purpose of the STAR program to is to better understand how to interrupt sitting time and the consequences for healthy aging in postmenopausal women. This protocol (also referred to Project 2 of the STAR program) is a 3-arm randomized control trial designed to assess ways of interrupting sitting in 405 overweight, postmenopausal women.
Detailed description
Primary Aims:
In our primary biomarker outcomes of glucose regulation (fasting insulin \& glucose, HbA1c, HOMA-IR) \& blood pressure (BP):
- Investigate the 12 week effects of increased standing and additional brief sit-to-stand compared to attention controls.
- Investigate the dose-response effects of behavioral change on the biomarkers \& BP.
Secondary aims
- Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on physical, emotional \& cognitive functioning.
- Assess the effect of changes in standing and sit-to-stand transitions at 12 weeks on in vivo skeletal muscle mitochondrial function.
Exploratory aims
- Explore the possible modifying effect of age on the relationship between intervention conditions \& primary \& secondary outcomes.
- Explore the psychosocial \& environmental mediators \& moderators of changes in sitting time, standing time, and transitions.
- Explore differences in outcomes between the 2 sitting interruption conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Health Living Attention Control | Active comparator | Behavioral: Health CoachingParticipants in the attention control condition will receive a healthy aging educational intervention. This group will receive one in-person health coaching sessions and 6 phone counseling sessions. |
| Reduce Sitting | Experimental | Behavioral: Health Coaching, Device: activPAL inclinometer, Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.Participants in the Reduce Sitting condition will receive an intervention aimed at reducing daily sitting time. This group will receive five in-person health coaching sessions and two phone counseling sessions. |
| Sit-to-Stand Transition | Experimental | Behavioral: Health Coaching, Device: activPAL inclinometer, Other: Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.Participants in the Sit-to-Stand Transition condition will receive an intervention aimed at increasing the daily number of brief sit-to-stand transitions. This group will receive five in-person health coaching sessions and two phone counseling sessions. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female;
- 55 years of age and above;
- any ethnicity or race;
- screened to sit for 7 or more hours per day, perform less than 70 sit-to-stand transitions per day
- ambulatory;
Key exclusion criteria (10 listed)
- Male;
- younger than 55 years of age;
- sit for less than 7 hours per day, perform 71 or more sit-to-stand transitions per day
- mental state that would preclude complete understanding of the protocol or compliance;
- physical limitations to completing any of the study conditions;
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 |
|---|---|---|
| Health CoachingHealth Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, \& relapse prevention. | Behavioural | Health Living Attention Control, Reduce Sitting, Sit-to-Stand Transition |
| activPAL inclinometerParticipants in the intervention study arms (B \& C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan. | Device | Reduce Sitting, Sit-to-Stand Transition |
| Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.Participants in the intervention study arms (B \& C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs. | Other | Reduce Sitting, Sit-to-Stand Transition |
Primary outcome
Insulin Regulation (mU/L)
Time frame: 3 months
Mean Insulin (mU/L) collected via fasting blood draw at Baseline and 3-Months
1 secondary outcome
Self-Reported Physical Functioning
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40709462Hartman SJ, LaCroix AZ, Sears DD, Natarajan L, Zablocki RW, Chen R, Patterson JS, Dillon L, Sallis JF, Schenk S, Dunstan DW, Owen N, Rosenberg DE. Impacts of Reducing Sitting Time or Increasing Sit-to-Stand Transitions on Blood Pressure and Glucose Regulation in Postmenopausal Women: Three-Arm Randomized Controlled Trial. Circulation. 2025 Aug 26;152(8):492-504. doi: 10.1161/CIRCULATIONAHA.124.073385. Epub 2025 Jul 25.
- Derived from this study: PubMed 38671485Zablocki RW, Hartman SJ, Di C, Zou J, Carlson JA, Hibbing PR, Rosenberg DE, Greenwood-Hickman MA, Dillon L, LaCroix AZ, Natarajan L. Using functional principal component analysis (FPCA) to quantify sitting patterns derived from wearable sensors. Int J Behav Nutr Phys Act. 2024 Apr 26;21(1):48. doi: 10.1186/s12966-024-01585-8.
- Derived from this study: PubMed 33983131Hartman SJ, Dillon LW, LaCroix AZ, Natarajan L, Sears DD, Owen N, Dunstan DW, Sallis JF, Schenk S, Allison M, Takemoto M, Herweck AM, Nguyen B, Rosenberg DE. Interrupting Sitting Time in Postmenopausal Women: Protocol for the Rise for Health Randomized Controlled Trial. JMIR Res Protoc. 2021 May 13;10(5):e28684. doi: 10.2196/28684.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching, activPAL inclinometer and Tools to Prompt Standing or Prompt Sit-to-Stand Transitions. in people with Sedentary Lifestyle, run by University of California, San Diego 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 12 inclusion and 10 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 3 Nov 2025. 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 3 Nov 2025). 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?
Insulin Regulation (mU/L) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473145, which also lists 3 linked publications.
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 3 Nov 2025.