Sedentary TimeSTARTNCT06023680
The Sedentary to Active Rising to Thrive (START) Trial
A study testing Continuous sedentary reduction intervention and Bouted sedentary reduction intervention in people with Sedentary Time and Frailty, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial summary
The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail. The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Time, Frailty
- What is being tested?
- Continuous sedentary reduction intervention and Bouted sedentary reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged ≥65 years
- Pre-frail defined as having 1-2 of the following criteria:
- Self-reported unintentional weight loss
- Self-reported fatigue
- Self-reported low activity
- Slowness measured during a 4-m walking test
Show all 12Show fewer
- Weakness measured with grip strength
- Self-reported regular physical activity <20 minutes/day
- Self-reported willingness to work up to walking for 30 minutes/day
- Self-reported ability to find a place to walk for up to 30 minutes/day
- Agree to all study procedures and assessments
- Ability to provide informed consent
Who cannot join
- Self-reported diabetes
- Self-reported problems related to alcohol or drugs
- Self-reported inability to walk across a room
- Self-reported use of a walker
- Self-reported requirement of medical supervision when engaging in physical activity
- Fallen >2 times in the past month
Show all 12Show fewer
- Participation in another clinical trial
- Plan to move out of the area within 6 months
- Inability to provide self-transportation to study assessment visits
- Inability to complete a usual-paced 400m walking test within 15 minutes without sitting or the help of another
- Uncontrolled resting hypertension (>160/90 mmHg)
- Cognitive impairment determined using the Montreal Cognitive Assessment Test
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins ProHealth
Baltimore, Maryland, 21207
Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: The Sedentary to Active Rising to Thrive (START) Trial: A Proof-of-Concept Sedentary Behavior Reduction Program
The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail.
The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days.
Read more
There are other questions this project aims to answer that include:
- whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts
- whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active
- whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism
Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.
Read the detailed description
Initiating and maintaining habitual physical activity is difficult for sedentary older adults, particularly those encumbered by health challenges. The 2018 US Physical Activity Guidelines recommends that all adults perform ≥150 minutes/week of physical activity and reduce sedentary behaviors. Yet, traditional approaches to increase physical activity do little to address sedentary behavior reduction, especially for older adults. Lower sedentary behavior is associated with improved biological and psychosocial health-independent of meeting physical activity guidelines. Thus, there remains a critical need to implement and evaluate a structured way to reduce sedentary behavior as a potential pathway for habitual physical activity engagement.
This project aims to test two prescribe-able and feasible strategies to initiate and incorporate sedentary behavior reduction into daily lifestyle with remote monitoring. The interventions are an inexpensive and low burden approach to reduce sedentary behavior and promote habitual physical activity. Moreover, accelerometer-based outcomes of sedentary behavior are novel in intervention settings, particularly when measured in free-living, real-world settings. Lastly, this project directly addresses a gap of successful remotely deployable interventions geared to initiate and build activity into daily life by replacing sedentary time among older adults.
Aim 1. Explore the effectiveness of 2 interventions to reduce sedentary time in pre-frail older adults over 2 months
Hypothesis 1a. Each intervention will reduce objectively measured daily sedentary time from baseline levels over 2 months.
Hypothesis 1b. The continuous intervention will result in more reduction of objectively measured sedentary time than the bouts intervention.
Aim 2. Explore the dose-response relationship between sedentary time changes and patient-reported outcomes that include fatigue, fatigability, anxiety, general and exercise-based self-efficacy, stress, pain, and mood over 2 months
Hypothesis 2: Decreased daily sedentary time over 2 months is associated with decreased fatigue, fatigability, anxiety, stress, and pain, and increased general and exercise-based self-efficacy and mood over 2 months.
Aim 3. Explore the dose-response relationship between sedentary time changes and biomarkers of frailty-related inflammation, including serum interleukin (IL-6) (pg/mL) and tumor necrosis factor (TNF) -alpha receptor 1 (pg/mL) over 2 months
Hypothesis 3. Decreased daily sedentary time is associated with decreased serum (IL-6) and TNF-alpha receptor 1 over 2 months.
Aim 4. Explore the dose-response relationship between changes in sedentary time with biomarkers of glucose and lipid metabolism (glucose, insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDLC), triglycerides, high-density lipoprotein cholesterol (HDLC)), a cytokine marker related to frailty (Growth/Differentiation Factor-15; (GDF-15), hemoglobin A1C (hbA1c), non-esterified free fatty acid, and untargeted metabolomics-based markers of energy regulation.
Hypothesis 4. Decreased daily sedentary time is associated with decreased levels of blood glucose, insulin, TC, LDLC, triglycerides and increased HDLC, decreased GDF-15, decreased hbA1c, decreased non-esterified free fatty acid, and lower circulating metabolites necessary for energy regulation over 2 months.
Aim 5. Explore the dose-response and diurnal relationships between changes in sedentary time and interstitial glucose continuously monitored over 24 hours for 14 consecutive days using a Libre Pro sensor at baseline and 2 months later
Hypothesis 5. Decreased sedentary time is associated with decreased overall glucose and different time-of-day glucose levels, coefficient of variation, % of time in glucose at various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, <70, <54 mg/dL), mean daily difference, and mean amplitude of glycemic excursion) over 2 months.
- Conditions
- Sedentary Time, Frailty
- Being tested
- Continuous sedentary reduction intervention, Bouted sedentary reduction intervention
- Keywords
- Physical Activity, Walking, Older Adults
- Medical subject headings
- Sedentary Behavior, Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous sedentary reduction interventionBehavioural
During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).
During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days.
Bouted sedentary reduction interventionBehavioural
During Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts).
During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Continuous sedentary reduction intervention | Active comparator | Structured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout Receives: Behavioral: Continuous sedentary reduction intervention |
| Bouted sedentary reduction intervention | Active comparator | Structured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts Receives: Behavioral: Bouted sedentary reduction intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sedentary Time
Sedentary time measured with a wrist worn monitor containing an accelerometer sensor
This measurement is collected under a 7-day/24-hour wear protocol at baseline and again 2 months afterwards to determine the change in sedentary time before and after either intervention.
Measured: Baseline, 2 months
Intervention Difference in the Change in Sedentary Time
Comparing the 2-month change in sedentary time between the two interventions
Measured: Baseline, 2 months
Secondary outcomes (23)
Change in Physical Activity Accumulation
Physical activity fragmentation (e.g., broken up activity accumulation) wrist worn monitor containing an accelerometer sensor
Measured: Baseline, 2 months
Change in Walking Ability
Ability to walk measured at a usual walking pace for 400m at baseline and 2 months afterwards.
Measured: Baseline, 2 months
Change in Walking Speed
Walking speed measured at a usual walking pace for 4m at baseline and 2 months afterwards.
Measured: Baseline, 2 months
Change in Fatigue
Fatigue measured using a Fatigue Scale questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-13 where higher scores mean higher fatigue.
Measured: Baseline, 2 months
Change in Fatigability
Fatigability measured using a Pittsburgh Fatigability questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-100 where higher scores mean higher fatigability.
Measured: Baseline, 2 months
Change in Anxiety
Anxiety measured using an Anxiety Scale questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-20 where higher scores mean higher anxiety.
Measured: Baseline, 2 months
Change in General Self Efficacy
General Self Efficacy measured using a General Self Efficacy questionnaire measured at baseline and 2 months afterwards
On the questionnaire, a score can range from 0-50 where higher scores mean higher general self efficacy.
Measured: Baseline, 2 months
Change in Exercise-based Self Efficacy
Exercise-based Self Efficacy measured using an Exercise-based Self Efficacy questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-90 where higher scores mean higher exercise-based self efficacy.
Measured: Baseline, 2 months
Change in Stress
Stress measured using a Perceived Stress Scale questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-70 where higher scores mean higher stress.
Measured: Baseline, 2 months
Change in Pain
Pain measured using a modified version of the McGill pain questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-5 where higher scores mean greater pain.
Measured: Baseline, 2 months
Change in Mood
Mood measured using a Profile of Mood Status questionnaire measured at baseline and 2 months afterwards.
On the questionnaire, a score can range from 0-20 where higher scores mean greater mood disturbance.
Measured: Baseline, 2 months
Change in Inflammation
Inflammation measured from blood draws quantifying serum IL-6 (pg/mL) and TNF-alpha receptor 1 (pg/mL) at baseline and 2 months afterwards
Measured: Baseline, 2 months
Change in Blood Glucose
Blood glucose measured from blood draws
Measured: Baseline, 2 months
Change in Insulin
Insulin measured from blood draws
Measured: Baseline, 2 months
Change in Total Cholesterol
Total cholesterol measured from blood draws
Measured: Baseline, 2 months
Change in Low-Density Lipoprotein Cholesterol
Low-density lipoprotein cholesterol measured from blood draws
Measured: Baseline, 2 months
Change in High-Density Lipoprotein Cholesterol
High-density lipoprotein cholesterol measured from blood draws
Measured: Baseline, 2 months
Change in Triglycerides
Triglycerides measured from blood draws
Measured: Baseline, 2 months
Change in Growth/Differentiation Factor-15
Growth/Differentiation Factor-15 measured from blood draws
Measured: Baseline, 2 months
Change in Metabolites
Untargeted metabolomics-based markers of energy regulation measured from blood draws
Measured: Baseline, 2 months
Change in Hemoglobin A1c
Hemoglobin A1c measured from blood draws
Measured: Baseline, 2 months
Change in Non-Esterified Free Fatty Acid
Non-Esterified Free Fatty Acid measured from blood draws
Measured: Baseline, 2 months
Change in Interstitial Glucose
Interstitial glucose measured using a continuous glucose monitor worn 24-hours each day for 14 consecutive days at baseline and 2 months afterwards. Specific measurements include overall glucose and different time-of-day glucose levels, coefficient of variation, % of time in glucose at various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, <70, <54 mg/dL), mean daily difference, and mean amplitude of glycemic excursion).
Measured: Baseline, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start28 Nov 2023
- Primary completion15 Jul 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary TimeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Amal Wanigatunga, PhD, Principal investigator, Johns Hopkins Blomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023680
- Sponsor's protocol ID
- IRB00023391
- Other IDs
- K01AG076967
- Acronym
- START
- Status last verified
- Oct 2026
- First submitted
- 29 Aug 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sedentary to Active Rising to Thrive (START) Trial: A Proof-of-Concept Sedentary Behavior Reduction Program
- ClinicalTrials.gov ID
- NCT06023680
- Acronym / sponsor ID
- START / IRB00023391
- Conditions
- Sedentary Time, Frailty
- Keywords
- Physical Activity, Walking, Older Adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this behavioral clinical trial is to compare two different ways of becoming less sedentary and more active in 60 older adults at elevated risk of becoming frail.
The main question this project aims to answer are whether participants in each intervention are able to gradually replace 30 minutes of sedentary (sitting-like) behavior with very light walking over 60 days.
There are other questions this project aims to answer that include:
- whether it is easier to replace sedentary behavior with one 30-minute walking bout or three 10-minute walking bouts
- whether becoming less sedentary and more active leads to feeling better, have less stress, pain, and fatigue and have more confidence in becoming more regularly active
- whether becoming less sedentary and more active leads to better regulation of inflammation and metabolism
Participants will be randomized into one of two sedentary reduction behavior programs; one program that gradually replaces sedentary time with one 30-minute walking bout and the other program that gradually replaces sedentary time with three 10-minute walking bouts in the morning, afternoon, and evening. Researchers will compare both programs to see which one is easier to achieve and maintain over 60 days.
Detailed description
Initiating and maintaining habitual physical activity is difficult for sedentary older adults, particularly those encumbered by health challenges. The 2018 US Physical Activity Guidelines recommends that all adults perform ≥150 minutes/week of physical activity and reduce sedentary behaviors. Yet, traditional approaches to increase physical activity do little to address sedentary behavior reduction, especially for older adults. Lower sedentary behavior is associated with improved biological and psychosocial health-independent of meeting physical activity guidelines. Thus, there remains a critical need to implement and evaluate a structured way to reduce sedentary behavior as a potential pathway for habitual physical activity engagement.
This project aims to test two prescribe-able and feasible strategies to initiate and incorporate sedentary behavior reduction into daily lifestyle with remote monitoring. The interventions are an inexpensive and low burden approach to reduce sedentary behavior and promote habitual physical activity. Moreover, accelerometer-based outcomes of sedentary behavior are novel in intervention settings, particularly when measured in free-living, real-world settings. Lastly, this project directly addresses a gap of successful remotely deployable interventions geared to initiate and build activity into daily life by replacing sedentary time among older adults.
Aim 1. Explore the effectiveness of 2 interventions to reduce sedentary time in pre-frail older adults over 2 months
Hypothesis 1a. Each intervention will reduce objectively measured daily sedentary time from baseline levels over 2 months.
Hypothesis 1b. The continuous intervention will result in more reduction of objectively measured sedentary time than the bouts intervention.
Aim 2. Explore the dose-response relationship between sedentary time changes and patient-reported outcomes that include fatigue, fatigability, anxiety, general and exercise-based self-efficacy, stress, pain, and mood over 2 months
Hypothesis 2: Decreased daily sedentary time over 2 months is associated with decreased fatigue, fatigability, anxiety, stress, and pain, and increased general and exercise-based self-efficacy and mood over 2 months.
Aim 3. Explore the dose-response relationship between sedentary time changes and biomarkers of frailty-related inflammation, including serum interleukin (IL-6) (pg/mL) and tumor necrosis factor (TNF) -alpha receptor 1 (pg/mL) over 2 months
Hypothesis 3. Decreased daily sedentary time is associated with decreased serum (IL-6) and TNF-alpha receptor 1 over 2 months.
Aim 4. Explore the dose-response relationship between changes in sedentary time with biomarkers of glucose and lipid metabolism (glucose, insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDLC), triglycerides, high-density lipoprotein cholesterol (HDLC)), a cytokine marker related to frailty (Growth/Differentiation Factor-15; (GDF-15), hemoglobin A1C (hbA1c), non-esterified free fatty acid, and untargeted metabolomics-based markers of energy regulation.
Hypothesis 4. Decreased daily sedentary time is associated with decreased levels of blood glucose, insulin, TC, LDLC, triglycerides and increased HDLC, decreased GDF-15, decreased hbA1c, decreased non-esterified free fatty acid, and lower circulating metabolites necessary for energy regulation over 2 months.
Aim 5. Explore the dose-response and diurnal relationships between changes in sedentary time and interstitial glucose continuously monitored over 24 hours for 14 consecutive days using a Libre Pro sensor at baseline and 2 months later
Hypothesis 5. Decreased sedentary time is associated with decreased overall glucose and different time-of-day glucose levels, coefficient of variation, % of time in glucose at various ranges (e.g., ≥200, ≥180, ≥140, 70-180, 70-140, <70, <54 mg/dL), mean daily difference, and mean amplitude of glycemic excursion) over 2 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous sedentary reduction intervention | Active comparator | Behavioral: Continuous sedentary reduction interventionStructured intervention to progressively replace sedentary time with one daily 30-minute light-intensity walking bout |
| Bouted sedentary reduction intervention | Active comparator | Behavioral: Bouted sedentary reduction interventionStructured intervention to progressively replace sedentary time with three daily 10-minute light-intensity walking bouts |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Adults aged ≥65 years
- Pre-frail defined as having 1-2 of the following criteria:
- Self-reported unintentional weight loss
- Self-reported fatigue
- Self-reported low activity
Key exclusion criteria (12 listed)
- Self-reported diabetes
- Self-reported problems related to alcohol or drugs
- Self-reported inability to walk across a room
- Self-reported use of a walker
- Self-reported requirement of medical supervision when engaging in physical activity
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 |
|---|---|---|
| Continuous sedentary reduction interventionDuring Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be gradually combined into one 30-minute bout over the course of 20 days. | Behavioural | Continuous sedentary reduction intervention |
| Bouted sedentary reduction interventionDuring Phase 1, one minute of sedentary time will be replaced with very light to light intensity walking at three different times during the day, every day for 10 days, reaching three separate 10-minute walking intervals (or bouts). During Phase 2, the three 10-minute walking bouts will be maintained over the course of 20 days. | Behavioural | Bouted sedentary reduction intervention |
Primary outcome
Change in Sedentary Time
Time frame: Baseline, 2 months
Sedentary time measured with a wrist worn monitor containing an accelerometer sensor This measurement is collected under a 7-day/24-hour wear protocol at baseline and again 2 months afterwards to determine the change in sedentary time before and after either intervention.
Intervention Difference in the Change in Sedentary Time
Time frame: Baseline, 2 months
Comparing the 2-month change in sedentary time between the two interventions
23 secondary outcomes
Change in Physical Activity Accumulation
Time frame: Baseline, 2 months
Change in Walking Ability
Time frame: Baseline, 2 months
Change in Walking Speed
Time frame: Baseline, 2 months
Change in Fatigue
Time frame: Baseline, 2 months
Change in Fatigability
Time frame: Baseline, 2 months
Change in Anxiety
Time frame: Baseline, 2 months
Change in General Self Efficacy
Time frame: Baseline, 2 months
Change in Exercise-based Self Efficacy
Time frame: Baseline, 2 months
Change in Stress
Time frame: Baseline, 2 months
Change in Pain
Time frame: Baseline, 2 months
Change in Mood
Time frame: Baseline, 2 months
Change in Inflammation
Time frame: Baseline, 2 months
Change in Blood Glucose
Time frame: Baseline, 2 months
Change in Insulin
Time frame: Baseline, 2 months
Change in Total Cholesterol
Time frame: Baseline, 2 months
Change in Low-Density Lipoprotein Cholesterol
Time frame: Baseline, 2 months
Change in High-Density Lipoprotein Cholesterol
Time frame: Baseline, 2 months
Change in Triglycerides
Time frame: Baseline, 2 months
Change in Growth/Differentiation Factor-15
Time frame: Baseline, 2 months
Change in Metabolites
Time frame: Baseline, 2 months
Change in Hemoglobin A1c
Time frame: Baseline, 2 months
Change in Non-Esterified Free Fatty Acid
Time frame: Baseline, 2 months
Change in Interstitial Glucose
Time frame: Baseline, 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Amal Wanigatunga, PhD principal investigator
Johns Hopkins Blomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous sedentary reduction intervention and Bouted sedentary reduction intervention in people with Sedentary Time and Frailty, run by Johns Hopkins Bloomberg School of Public Health at 2 sites 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 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 Sedentary Time (time frame: Baseline, 2 months). The study lists 2 primary outcomes in all. 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 5 Oct 2026.