PreDiabetesNCT04269070
WorkWell: Work-based Activity and Metabolic Health
A study testing Standing condition, Light physical activity (LPA) condition and Usual behavior condition in people with PreDiabetes and Obesity, run by Arizona State University at 1 site in United States.
Trial summary
This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Obesity
- What is being tested?
- Standing condition, Light physical activity (LPA) condition and Usual behavior condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2021to 30 Apr 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women and men age 18 yrs and older
- Holds a job where primary work activities are done seated
- Has the space and ability to use a sit-to-stand workstation in their primary workspace
- Works in an office setting or remotely for ≥ 4 days per week
- Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)
Who cannot join
- Currently taking diabetes medication
- Taking any of the following medications or treatments:
- Medication to control high blood pressure
- Medication to treat high glucose
- Blood thinners
- Hormone replacement therapy (in the past 12 months)
Show all 19Show fewer
- Corticosteroids
- High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage)
- 2nd generation antipsychotics
- Current or previous foot or lower limb injuries
- Current use of sit-stand workstation
- Current smoker
- Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues
- Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes
- Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider
- History of inflammatory bowel or intestinal malabsorption conditions
- Use of prebiotics, probiotics or antibiotics in the last 3 months
- Serious food allergies or restrictions
- Participants who will be travelling 3 or more days out of their typical week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.
Read the detailed description
This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.
Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior.
- Conditions
- PreDiabetes, Obesity
- Being tested
- Standing condition, Light physical activity (LPA) condition, Usual behavior condition
- Keywords
- sedentary, prediabetes, lifestyle modification, cardiometabolic health
- Medical subject headings
- Prediabetic State, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing conditionBehavioural
Participants will be asked to stand an additional 6 minutes per hour above their median standing time from the observed time in the usual behavior condition.
Light physical activity (LPA) conditionBehavioural
Participants will be asked to perform 6 additional minutes per hour above their median LPA time from the observed time in the usual behavior condition.
Usual behavior conditionBehavioural
Participants will be asked to perform their normal work activities in their normal work environment for one week. There will be no modifications to their work environment or instructions given of what activities to partake in. This period will be used to understand their normal standing and LPA behaviors to determine the personalized changes to their standing and LPA behaviors in the other conditions.
| Study group | Role | What they receive |
|---|---|---|
| Move, Stand | Active comparator | Usual behavior condition, followed by the standing condition, followed by the LPA condition. Receives: Behavioral: Standing condition; Behavioral: Light physical activity (LPA) condition; Behavioral: Usual behavior condition |
| Stand, Move | Active comparator | Usual behavior condition, followed by the LPA condition, followed by the standing condition. Receives: Behavioral: Standing condition; Behavioral: Light physical activity (LPA) condition; Behavioral: Usual behavior condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
Participants will be asked to wear the Abbott Freestyle Libre continuous glucose monitor during the usual behavior condition (week 1) and both experimental conditions (weeks 2-3 and weeks 5-6). Research staff will insert the CGM sensor at the screening and study visits. The training for this insertion will be conducted by a registered research nurse. The CGM sensors have been designed and tested to be worn continuously for up to 14 days. Sensors will be placed and removed by trained research staff at appropriate time-points throughout the study. Postprandial period will follow a standardize lunch meal. Area-under-the-curve calculations will be based on 2 hours following delivery of this lunch meal.
Measured: 2 weeks
Secondary outcomes (2)
Change in baseline workplace standing time at 2 weeks
Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.
Measured: 2 weeks
Change in baseline workplace stepping time at 2 weeks
Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start25 Mar 2021
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a crossover trial where study participants will experience two conditions following a baseline usua behavior conditions. All study participants will experience each of the conditions: a standing condition, and a light intensity physical activity (LPA) intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269070
- Sponsor's protocol ID
- STUDY00010172
- Status last verified
- May 2023
- First submitted
- 3 Jan 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wilson SL, Crosley-Lyons R, Junk J, Hasanaj K, Larouche ML, Hollingshead K, Gu H, Whisner C, Sears DD, Buman MP. Effects of Increased Standing and Light-Intensity Physical Activity to Improve Postprandial Glucose in Sedentary Office Workers: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2023 Aug 23;12:e45133. doi: 10.2196/45133.
PubMed 37610800
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers
- ClinicalTrials.gov ID
- NCT04269070
- Acronym / sponsor ID
- STUDY00010172
- Conditions
- PreDiabetes, Obesity
- Keywords
- sedentary, prediabetes, lifestyle modification, cardiometabolic health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 13 Feb 2020 (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.
This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments.
Detailed description
This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.
Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a crossover trial where study participants will experience two conditions following a baseline usua behavior conditions. All study participants will experience each of the conditions: a standing condition, and a light intensity physical activity (LPA) intervention.
| Arm | Type | Receives |
|---|---|---|
| Move, Stand | Active comparator | Behavioral: Standing condition, Behavioral: Light physical activity (LPA) condition, Behavioral: Usual behavior conditionUsual behavior condition, followed by the standing condition, followed by the LPA condition. |
| Stand, Move | Active comparator | Behavioral: Standing condition, Behavioral: Light physical activity (LPA) condition, Behavioral: Usual behavior conditionUsual behavior condition, followed by the LPA condition, followed by the standing condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women and men age 18 yrs and older
- Holds a job where primary work activities are done seated
- Has the space and ability to use a sit-to-stand workstation in their primary workspace
- Works in an office setting or remotely for ≥ 4 days per week
- Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)
Key exclusion criteria (19 listed)
- Currently taking diabetes medication
- Taking any of the following medications or treatments:
- Current or previous foot or lower limb injuries
- Current use of sit-stand workstation
- Current smoker
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 |
|---|---|---|
| Standing conditionParticipants will be asked to stand an additional 6 minutes per hour above their median standing time from the observed time in the usual behavior condition. | Behavioural | Move, Stand, Stand, Move |
| Light physical activity (LPA) conditionParticipants will be asked to perform 6 additional minutes per hour above their median LPA time from the observed time in the usual behavior condition. | Behavioural | Move, Stand, Stand, Move |
| Usual behavior conditionParticipants will be asked to perform their normal work activities in their normal work environment for one week. There will be no modifications to their work environment or instructions given of what activities to partake in. This period will be used to understand their normal standing and LPA behaviors to determine the personalized changes to their standing and LPA behaviors in the other conditions. | Behavioural | Move, Stand, Stand, Move |
Primary outcome
Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks
Time frame: 2 weeks
Participants will be asked to wear the Abbott Freestyle Libre continuous glucose monitor during the usual behavior condition (week 1) and both experimental conditions (weeks 2-3 and weeks 5-6). Research staff will insert the CGM sensor at the screening and study visits. The training for this insertion will be conducted by a registered research nurse. The CGM sensors have been designed and tested to be worn continuously for up to 14 days. Sensors will be placed and removed by trained research staff at appropriate time-points throughout the study. Postprandial period will follow a standardize lunch meal. Area-under-the-curve calculations will be based on 2 hours following delivery of this lunch meal.
2 secondary outcomes
Change in baseline workplace standing time at 2 weeks
Time frame: 2 weeks
Change in baseline workplace stepping time at 2 weeks
Time frame: 2 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 10 May 2023.
- Derived from this study: PubMed 37610800Wilson SL, Crosley-Lyons R, Junk J, Hasanaj K, Larouche ML, Hollingshead K, Gu H, Whisner C, Sears DD, Buman MP. Effects of Increased Standing and Light-Intensity Physical Activity to Improve Postprandial Glucose in Sedentary Office Workers: Protocol for a Randomized Crossover Trial. JMIR Res Protoc. 2023 Aug 23;12:e45133. doi: 10.2196/45133.
- 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 Standing condition, Light physical activity (LPA) condition and Usual behavior condition in people with PreDiabetes and Obesity, run by Arizona State University 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 19 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 10 May 2023. 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 2-hour postprandial area-under-the-curve blood glucose at 2 weeks (time frame: 2 weeks). 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 NCT04269070, which also lists 1 linked publication.
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 10 May 2023.