Blood PressureNCT03698903
Take a STAND 4 Health: A Sedentary Behavior Reduction Intervention
A study testing Take a STAND 4 Health in people with Blood Pressure, run by University of South Carolina at 1 site in United States.
Trial summary
There is emerging evidence that an excessive amount of sitting is linked with an increased risk of negative health outcomes independent of an individual's physical activity levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Take a STAND 4 Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years or older
- Having a BMI between 25 and 50 kg/m2
- Owning a smartphone that is accessible during the day
- Living or working within 30 miles of University of South Carolina (USC)
- Willing to wear the activPAL for baseline assessment
- An average self-reported sedentary time of at least 7 hours over the past 7 days
- Willing to be randomized to either group
Who cannot join
- Inability to walk without assistance
- Recent use of psychotropic medications or treatment for psychological issues, with the exception of anxiety and depression
- Current treatment for cancer or other serious medical conditions such as renal failure
- Injury or illness that prohibits standing or walking
- Pregnant or gave birth within the last 6 months
- Does not live or work within 30 miles of USC
Show all 9Show fewer
- Currently enrolled in a weight loss, physical activity, or stress management program
- A known vacation or a major alteration in their normal schedule in the next 4 months
- Unwilling to wear the accelerometer for 7 days at any assessment period or had an adverse reaction to wearing the accelerometer during baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29223
About this study
Official title: Evaluating the Effects of a Sedentary Behavior Reduction Intervention on the Sedentary Time and Blood Pressure of Overweight/Obese Adults
There is emerging evidence that an excessive amount of sitting is linked with an increased risk of negative health outcomes independent of an individual's physical activity levels. This is concerning considering data indicate Americans spend over half of the waking day engaged in sedentary activities, and that individuals who are overweight or obese and/or have a chronic disease such as hypertension are likely to have an even higher level of sedentary behavior. A limited number of experimental studies have looked at the effects of reducing sitting time on blood pressure and have shown promise. However, these studies lasted for only a day, so it is unclear how reducing sedentary time may influence blood pressure over a longer duration. The purpose of this study is to look the relationships between the amount of time a person spends sitting and their blood pressure and examine whether decreasing sedentary behavior helps improve blood pressure. The study employs the use of coaching calls and a mobile health (mHealth) intervention to reduce the sedentary behavior of participants through strategies such as prompting, feedback, and counseling.
Read the detailed description
The purpose of this study is to determine the effect of a 4-week sedentary behavior reduction intervention on objectively measured sedentary behavior of overweight or obese adults. The proposed study is a pilot, proof-of-concept randomized controlled trial that will randomize participants to either the 1) Immediate Intervention group, which will receive coaching calls + a mHealth intervention for the first four weeks of the study and then will receive only the mHealth intervention for the remaining 4 weeks or the 2) Delayed Intervention Control group, which will act as an assessment-only condition for the first 4 weeks and then will receive the coaching calls + mHealth intervention for 4-weeks. This design has two phases: Phase 1, which is a randomized controlled feasibility pilot and the primary study focus, followed by Phase 2, which is an exploratory phase, allowing replication of the intervention (in the Delayed Intervention Control group) and extended follow-up (in the Immediate Intervention group).
The study outcomes to be investigated in Phase 1 include:
- 1) the change in total % sedentary time from baseline to the 4-week assessment, comparing the average proportion of objectively-measured time spent sitting during the waking day across the previous week in the Immediate Intervention group (which will have received the 4-week coaching calls + mHealth sedentary behavior reduction intervention) with the average proportion of objectively-measured waking sedentary time across the previous week in the Delayed Intervention Control group (which will have received assessment only during this period).
- 2) the change in blood pressure, comparing the Immediate Intervention group (which will have received the 4-week coaching calls + mHealth sedentary behavior reduction intervention) with the Delayed Intervention Control group (which will have received assessment only during this period).
- 3) Process data on participant recruitment to the study, and, among those randomized to the Immediate intervention, engagement with the intervention (e.g., response rates to the texts, completion of intervention phone calls, etc.), and participant evaluation of the intervention.
The study outcomes to be investigated in Phase 2 include:
- 1) Objectively measured sedentary behavior in the Immediate Intervention group 4 weeks post-treatment (i.e. at 8-week assessment), allowing quantification of maintenance of sedentary behavior reduction following the termination of coaching calls.
- 2) Objectively-measured sedentary behavior and blood pressure at 8 weeks post randomization in the Delayed Intervention Control group (i.e. following implementation of the 4-week coaching calls+ mHealth intervention), allowing assessment of whether intervention effects are reproducible.
- Conditions
- Blood Pressure
- Being tested
- Take a STAND 4 Health
- Keywords
- Intervention, Sedentary Behavior, Overweight or obese adults
- Medical subject headings
- Sedentary Behavior, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take a STAND 4 HealthBehavioural
The 4-week is comprised of several elements, including: (1) an in-person introductory session to acquaint the individuals with all intervention elements, customize to their preferences and describe the mHealth component of the intervention; (2) a website that will provide individualized feedback over time on the participant's scheduled breaks, sedentary time reduction, and sedentary patterns; (3) texts to serve as prompts and alert the participant to stand or move, with a goal of a 60 minute reduction per day, which are customized to the individual's schedule, personal preference and sedentary profile; and (4) two coaching phone calls to trouble shoot and problem solve implementation of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Take a STAND 4 Health: Immediate | Experimental | Receives the coaching calls + mHealth intervention first, then receives only the mHealth intervention after the 4 week assessment. Receives: Behavioral: Take a STAND 4 Health |
| Take a STAND 4 Health: Delayed | Active comparator | Will receive no intervention for the first 4 weeks but then after assessment will be provided the opportunity to receive the full coaching calls + mHealth intervention. Receives: Behavioral: Take a STAND 4 Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent time spent sedentary
activPAL device
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (9)
Blood pressure
Automated blood pressure machine
Measured: Baseline, 1 week, 4 weeks, 8 weeks
Percent time spent in light physical activity
activPAL device
Measured: Baseline, 4 weeks, 8 weeks
Percent time spent in moderate-to-vigorous physical activity
activPAL device
Measured: Baseline, 4 weeks, 8 weeks
Self-reported sedentary behavior
The Sedentary Behavior Questionnaire is assesses domain specific sedentary time on both a weekday and weekend. The scale ranges from "none" to "6 or more hours" for each sedentary activity, with a higher value indicating a higher amount of sedentary time. All responses are summed and the value is the individuals sedentary time.
Measured: Baseline, 1 week, 4 weeks, 8 weeks
Self-reported physical activity
The International Physical Activity Questionnaire- Short form measures the frequency (0-7 days) and amount of time (number of hours and minutes) an individual spends in vigorous intensity physical activity, moderate intensity physical activity, and walking. The total number of metabolic equivalent (MET) minutes per week are calculated from these responses. The survey also assess an individuals total sedentary time on a weekday.
Measured: Baseline, 4 weeks, 8 weeks
Waist circumference
Gulick tape
Measured: Baseline, 1 week, 4 weeks, 8 weeks
Weight
Calibrated Tanita body weight scale that measures weight in both pounds and kilograms.
Measured: Baseline, 1 week, 4 weeks, 8 weeks
Height
Stadiometer
Measured: Baseline
Treatment Satisfaction
Survey
Measured: 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Aug 2018
- Primary completion30 Oct 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chelsea Larsen, University of South Carolina
- Investigators
- Chelsea Larsen, MPH, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698903
- Sponsor's protocol ID
- Pro00079096
- Status last verified
- Nov 2020
- First submitted
- 17 Sep 2018
- Last updated
- 5 Nov 2020
- Results posted
- No
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of a Sedentary Behavior Reduction Intervention on the Sedentary Time and Blood Pressure of Overweight/Obese Adults
- ClinicalTrials.gov ID
- NCT03698903
- Acronym / sponsor ID
- Pro00079096
- Conditions
- Blood Pressure
- Keywords
- Intervention, Sedentary Behavior, Overweight or obese adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 9 Oct 2018 (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.
There is emerging evidence that an excessive amount of sitting is linked with an increased risk of negative health outcomes independent of an individual's physical activity levels. This is concerning considering data indicate Americans spend over half of the waking day engaged in sedentary activities, and that individuals who are overweight or obese and/or have a chronic disease such as hypertension are likely to have an even higher level of sedentary behavior. A limited number of experimental studies have looked at the effects of reducing sitting time on blood pressure and have shown promise. However, these studies lasted for only a day, so it is unclear how reducing sedentary time may influence blood pressure over a longer duration. The purpose of this study is to look the relationships between the amount of time a person spends sitting and their blood pressure and examine whether decreasing sedentary behavior helps improve blood pressure. The study employs the use of coaching calls and a mobile health (mHealth) intervention to reduce the sedentary behavior of participants through strategies such as prompting, feedback, and counseling.
Detailed description
The purpose of this study is to determine the effect of a 4-week sedentary behavior reduction intervention on objectively measured sedentary behavior of overweight or obese adults. The proposed study is a pilot, proof-of-concept randomized controlled trial that will randomize participants to either the 1) Immediate Intervention group, which will receive coaching calls + a mHealth intervention for the first four weeks of the study and then will receive only the mHealth intervention for the remaining 4 weeks or the 2) Delayed Intervention Control group, which will act as an assessment-only condition for the first 4 weeks and then will receive the coaching calls + mHealth intervention for 4-weeks. This design has two phases: Phase 1, which is a randomized controlled feasibility pilot and the primary study focus, followed by Phase 2, which is an exploratory phase, allowing replication of the intervention (in the Delayed Intervention Control group) and extended follow-up (in the Immediate Intervention group).
The study outcomes to be investigated in Phase 1 include:
- 1) the change in total % sedentary time from baseline to the 4-week assessment, comparing the average proportion of objectively-measured time spent sitting during the waking day across the previous week in the Immediate Intervention group (which will have received the 4-week coaching calls + mHealth sedentary behavior reduction intervention) with the average proportion of objectively-measured waking sedentary time across the previous week in the Delayed Intervention Control group (which will have received assessment only during this period).
- 2) the change in blood pressure, comparing the Immediate Intervention group (which will have received the 4-week coaching calls + mHealth sedentary behavior reduction intervention) with the Delayed Intervention Control group (which will have received assessment only during this period).
- 3) Process data on participant recruitment to the study, and, among those randomized to the Immediate intervention, engagement with the intervention (e.g., response rates to the texts, completion of intervention phone calls, etc.), and participant evaluation of the intervention.
The study outcomes to be investigated in Phase 2 include:
- 1) Objectively measured sedentary behavior in the Immediate Intervention group 4 weeks post-treatment (i.e. at 8-week assessment), allowing quantification of maintenance of sedentary behavior reduction following the termination of coaching calls.
- 2) Objectively-measured sedentary behavior and blood pressure at 8 weeks post randomization in the Delayed Intervention Control group (i.e. following implementation of the 4-week coaching calls+ mHealth intervention), allowing assessment of whether intervention effects are reproducible.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Take a STAND 4 Health: Immediate | Experimental | Behavioral: Take a STAND 4 HealthReceives the coaching calls + mHealth intervention first, then receives only the mHealth intervention after the 4 week assessment. |
| Take a STAND 4 Health: Delayed | Active comparator | Behavioral: Take a STAND 4 HealthWill receive no intervention for the first 4 weeks but then after assessment will be provided the opportunity to receive the full coaching calls + mHealth intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being 18 years or older
- Having a BMI between 25 and 50 kg/m2
- Owning a smartphone that is accessible during the day
- Living or working within 30 miles of University of South Carolina (USC)
- Willing to wear the activPAL for baseline assessment
Key exclusion criteria (9 listed)
- Inability to walk without assistance
- Recent use of psychotropic medications or treatment for psychological issues, with the exception of anxiety and depression
- Current treatment for cancer or other serious medical conditions such as renal failure
- Injury or illness that prohibits standing or walking
- Pregnant or gave birth within the last 6 months
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 |
|---|---|---|
| Take a STAND 4 HealthThe 4-week is comprised of several elements, including: (1) an in-person introductory session to acquaint the individuals with all intervention elements, customize to their preferences and describe the mHealth component of the intervention; (2) a website that will provide individualized feedback over time on the participant's scheduled breaks, sedentary time reduction, and sedentary patterns; (3) texts to serve as prompts and alert the participant to stand or move, with a goal of a 60 minute reduction per day, which are customized to the individual's schedule, personal preference and sedentary profile; and (4) two coaching phone calls to trouble shoot and problem solve implementation of the intervention. | Behavioural | Take a STAND 4 Health: Delayed, Take a STAND 4 Health: Immediate |
Primary outcome
Change in percent time spent sedentary
Time frame: Baseline, 4 weeks, 8 weeks
activPAL device
9 secondary outcomes
Blood pressure
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Percent time spent in light physical activity
Time frame: Baseline, 4 weeks, 8 weeks
Percent time spent in moderate-to-vigorous physical activity
Time frame: Baseline, 4 weeks, 8 weeks
Self-reported sedentary behavior
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Self-reported physical activity
Time frame: Baseline, 4 weeks, 8 weeks
Waist circumference
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Weight
Time frame: Baseline, 1 week, 4 weeks, 8 weeks
Height
Time frame: Baseline
Treatment Satisfaction
Time frame: 4 weeks, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
Related trials for Blood Pressure
Not yet recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Team-Based Shared Decision-Making Program in Hypertension Control (Healthy Heart - BP Program)
Hypertension (HTN), Blood Pressure
Recruiting
Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults
Aging
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
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.
Chelsea Larsen, MPH principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take a STAND 4 Health in people with Blood Pressure, run by University of South Carolina 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 7 inclusion and 9 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 5 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 percent time spent sedentary (time frame: Baseline, 4 weeks, 8 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 5 Nov 2020.