Sedentary TimeNCT06963736
WatchWell: Simple and Practical Strategies to Reduce the Negative Health Impact of Sedentary Screen Time
A study testing Blue light, Eating and Standing in people with Sedentary Time and Cardiovascular Diseases, run by Arizona State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility, acceptability, efficacy, and participant adherence in using home-based technologies and wearable devices and simple, practical strategies to reduce the negative impact that evening screen time may have on your health. Read more about this study
- Who is it for?
- Ages 26 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Time, Cardiovascular Diseases, Prediabetes
- What is being tested?
- Blue light, Eating and Standing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2025to 9 Jul 2026
- 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 26 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥26 years of age
- BMI ≥ 27 kg/m2*; ≥25 kg/m2, if Asian (full or multiple race)**
- Insufficiently active (per US National Guidelines for Physical Activity of 150 minutes of MVPA/Week)
- Reporting an average of ≥3 hours of recreational sedentary screen time (rSST) per day, that usually extends at least until 9:00pm.
- On a typical night, consumes calories (food and/or drink) after 8:00pm.
- Meet at least 2 criteria for metabolic syndrome
Show all 11Show fewer
- Central adiposity: waist circumference >40 inches (men); >35 inches (women)
- Elevated blood pressure: SBP >130 mmHg and/or DBP >85 mmHg OR controlled with medication
- Low high density lipoprotein (HDL) cholesterol: <40 mg/dL (men); <50 mg/dL (women)
- Elevated triglycerides: >150 mg/dL OR controlled with medication
- Elevated fasting glucose: ≥100 mg/dL OR controlled with medication
Who cannot join
- Conditions related to sleep disruption, including lactation, pregnancy, mid-night care providers, sleep disorders, severe sleep apnea
- History of hypoglycemia
- Pacemaker
- Caffeine consumption in excess and/or after 5pm (excess equals >4 cups of coffee per day or equivalent)
- Involvement in other physical activity, diet, or weight loss programs/studies
- Weight change of 5% up or down in the last three months.
Show all 20Show fewer
- Drug abuse
- THC use (smoking, edibles)
- Excessive alcohol use (for women, 8 or more drinks per week; for men, 15 or more drinks per week)
- Current smoker or user of any nicotine source - any amount or form (vapor/e-cig/tobacco/patch, gum, etc.)
- Medications that markedly impact glucose metabolism and sleep (insulin, corticosteroids, growth hormone, melatonin)
- Previous or current diagnosis of a clinical eating disorder (e.g., night eating syndrome, anorexia, bulimia, binge eating disorder); or self-report eating disorder behaviors
- Unstable or poorly controlled blood glucose (e.g., hypoglycemia, fasting glucose greater than 125 mg/dL)
- Chronic illness that may be associated with weight change (HIV/AIDS, active cancer, or uncontrolled thyroid disease)
- Shift work
- Recent or upcoming jetlag (travel 3 months prior and during study that is >1 time zone away from Arizona)
- Current practice of evening and nighttime blue light blocking.
- Poorly controlled hypertension (SBP ≥165 or DBP ≥100)
- Any condition or circumstance that would prevent compliance to the protocol
- Use non-android phone as their primary/personal phone
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the feasibility, acceptability, efficacy, and participant adherence in using home-based technologies and wearable devices and simple, practical strategies to reduce the negative impact that evening screen time may have on your health.
Read the detailed description
Sedentary screen time (SST) is the most common discretionary activity among all US age and race/ethnic groups. SST is associated with poor health outcomes, including cardiovascular disease (CVD). Recreational SST (rSST) is 2-3X more detrimental to health than other forms of sedentary behavior (e.g., workplace sitting, traveling). Elucidating the mechanisms that lead to elevated harm resulting from rSST is critical. Impact of the COVID-19 pandemic to increase rSST amplifies the urgency of understanding rSST-related mechanisms that lead to detrimental health outcomes. Previous SST studies are limited in scope of intervention and outcomes. There are vital gaps in knowledge about how rSST and rSST-associated behaviors lead to increased CVD risk. Interventions applied in ecologically valid, real-world settings are urgently needed to develop the most potent interventions that address and attenuate critical mechanistic pathways that mediate rSST-associated health risks. WatchWell is a pilot study designed to achieve three important goals that will support our obtaining funding for this research and is responsive to reviewer comments on our previously submitted NIH/NHLBI P01 Program Project: 1) demonstrate feasibility and participant acceptability of study design 2) demonstrate participant acceptability of measurement devices; 3) generate preliminary data to estimate outcome effect sizes.
In the course of WatchWell, the team of investigators will intervene on 3 behavioral mechanisms that are likely primary drivers of dSST CVD risk based on their prominent co-occurrence with rSST and individual contributions to CVD risk: blue light at night, nighttime food intake and prolonged evening sitting time. The investigators hypothesize that these 3 behavioral mechanisms impact CVD risk via downstream biological mechanisms including diurnal sleep/wake and body temperature rhythms, glucose metabolism, and autonomic balance (including heart rate variability, HRV). These biological mechanisms have not been assessed concurrently nor in the real-time, real-world context of rSST-related behaviors.
For this WorkWell pilot, the team of investigators will test 2 of the 3 behavioral mechanisms compared to the baseline control condition per participant using a 3-condition randomized controlled crossover design. [In the full trial to be resubmitted to the NIH, we will conduct a 4-condition crossover RCT, testing all 3 behavioral mechanisms compared to the baseline control condition per participant.] The investigators will recruit adults with overweight and at least 2 criteria of the metabolic syndrome (goal of N=18 completers, up to 30 enrollees total), who have elevated CVD risk. Impact. Recreational SST is a highly prevalent, modifiable risk factor for CVD. WorkWell will be the first to intervene on rSST-associated evening/nighttime blue light, food intake, and prolonged sitting in a real-world setting and to concurrently measure downstream CVD-related biological mechanisms. The WorkWell study design is informed by and will contribute to the translational application of circadian biology.
Aim 1. Assess the study feasibility and participant acceptability of delivering three behavioral strategies (avoiding dietary intake after 8p; blocking blue-light exposure after 8p; and breaking up prolonged sitting with standing after 5p) to reduce negative health exposures associated with rSST over two-week conditions in a randomized crossover study design.
Aim 2. Assess protocol compliance and participant acceptability of a suite of wearable sensors and home-based technologies during the feasibility trial.
Aim 3. Assess the preliminary efficacy and estimate effect size of the three behavioral strategies for improving postprandial glucose metabolism (primary focus on post-dinner meal, postprandial period), related 24-hr behaviors (sleep, other sedentary time, physical activity), heart rate variability, and circadian rhythms (sleep/wake activity rhythms, surface body temperature rhythms).
- Conditions
- Sedentary Time, Cardiovascular Diseases, Prediabetes, Obesity
- Being tested
- Blue light, Eating, Standing
- Keywords
- sedentary screen time, blue light, sedentary behavior, standing, crossover design, glucose metabolism
- Medical subject headings
- Sedentary Behavior, Cardiovascular Diseases, Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue lightBehavioural
Blue light blocking glasses use and discouraged late night eating.
EatingBehavioural
Encouraged not to eat past 8pm.
StandingBehavioural
Encouraged to stand for 10 minutes per hour each out from 5pm to bed time.
| Study group | Role | What they receive |
|---|---|---|
| Blue light-Eating | Experimental | Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.
Intervention 2: Participants will be encouraged to stop eating at 8pm. Receives: Behavioral: Blue light; Behavioral: Eating |
| Blue light-standing | Experimental | Intervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time.
Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. Receives: Behavioral: Blue light; Behavioral: Standing |
| Eating-Standing | Experimental | Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. Receives: Behavioral: Eating; Behavioral: Standing |
| Eating-Blue Light | Experimental | Intervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. Receives: Behavioral: Blue light; Behavioral: Eating |
| Standing-Blue Light | Experimental | Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.
Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. Receives: Behavioral: Blue light; Behavioral: Standing |
| Standing-Eating | Experimental | Intervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour.
Intervention 2: Participants will be encouraged to stop eating at 8pm. Receives: Behavioral: Eating; Behavioral: Standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment acceptability
Intervention acceptability will be assessed using the Treatment Evaluation Questionnaire (TEQ) to measure acceptability of the three experimental conditions following the completion of each condition. Scale Range: 0 to 4. Higher scores indicate greater acceptability.
Measured: 2 weeks
Changes in Evening Sedentary Screen Time
Minutes per week of screen time after 5p as measured by WatchWell app and activPAL
Measured: 2 weeks
Change in evening postprandial glycemic control (5pm - 5am)
Participants will be asked to wear the Dexcom G6 Pro continuous glucose monitor during baseline and experimental conditions. Glycemic control will be calculated by averaging all glucose readings from 5pm - 5am during each of the conditions.
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 posted9 May 2025
- Study start7 Aug 2025
- Primary completion9 Jul 2026
- Study completion9 Jul 2026
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 Arizona State UniversityThe 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
- Crossover
- Model description
- This is a crossover trial where study participants will experience two conditions following a baseline usual behavior condition. All study participants will experience two of three following conditions: avoiding dietary intake after 8p; blocking blue-light exposure after 8p; and breaking up prolonged sitting with standing after 5p.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P Buman, PhD, Arizona State University
- Investigators
- Dorothy Sears, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963736
- Sponsor's protocol ID
- STUDY00021203
- Status last verified
- Sep 2026
- First submitted
- 29 Apr 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WatchWell: Simple and Practical Strategies to Reduce the Negative Health Impact of Sedentary Screen Time
- ClinicalTrials.gov ID
- NCT06963736
- Acronym / sponsor ID
- STUDY00021203
- Conditions
- Sedentary Time, Cardiovascular Diseases, Prediabetes, Obesity
- Keywords
- sedentary screen time, blue light, sedentary behavior, standing, crossover design, glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 9 Jul 2026 (actual)
- Study completion
- 9 Jul 2026 (actual)
- First posted
- 9 May 2025 (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 purpose of this study is to determine the feasibility, acceptability, efficacy, and participant adherence in using home-based technologies and wearable devices and simple, practical strategies to reduce the negative impact that evening screen time may have on your health.
Detailed description
Sedentary screen time (SST) is the most common discretionary activity among all US age and race/ethnic groups. SST is associated with poor health outcomes, including cardiovascular disease (CVD). Recreational SST (rSST) is 2-3X more detrimental to health than other forms of sedentary behavior (e.g., workplace sitting, traveling). Elucidating the mechanisms that lead to elevated harm resulting from rSST is critical. Impact of the COVID-19 pandemic to increase rSST amplifies the urgency of understanding rSST-related mechanisms that lead to detrimental health outcomes. Previous SST studies are limited in scope of intervention and outcomes. There are vital gaps in knowledge about how rSST and rSST-associated behaviors lead to increased CVD risk. Interventions applied in ecologically valid, real-world settings are urgently needed to develop the most potent interventions that address and attenuate critical mechanistic pathways that mediate rSST-associated health risks. WatchWell is a pilot study designed to achieve three important goals that will support our obtaining funding for this research and is responsive to reviewer comments on our previously submitted NIH/NHLBI P01 Program Project: 1) demonstrate feasibility and participant acceptability of study design 2) demonstrate participant acceptability of measurement devices; 3) generate preliminary data to estimate outcome effect sizes.
In the course of WatchWell, the team of investigators will intervene on 3 behavioral mechanisms that are likely primary drivers of dSST CVD risk based on their prominent co-occurrence with rSST and individual contributions to CVD risk: blue light at night, nighttime food intake and prolonged evening sitting time. The investigators hypothesize that these 3 behavioral mechanisms impact CVD risk via downstream biological mechanisms including diurnal sleep/wake and body temperature rhythms, glucose metabolism, and autonomic balance (including heart rate variability, HRV). These biological mechanisms have not been assessed concurrently nor in the real-time, real-world context of rSST-related behaviors.
For this WorkWell pilot, the team of investigators will test 2 of the 3 behavioral mechanisms compared to the baseline control condition per participant using a 3-condition randomized controlled crossover design. [In the full trial to be resubmitted to the NIH, we will conduct a 4-condition crossover RCT, testing all 3 behavioral mechanisms compared to the baseline control condition per participant.] The investigators will recruit adults with overweight and at least 2 criteria of the metabolic syndrome (goal of N=18 completers, up to 30 enrollees total), who have elevated CVD risk. Impact. Recreational SST is a highly prevalent, modifiable risk factor for CVD. WorkWell will be the first to intervene on rSST-associated evening/nighttime blue light, food intake, and prolonged sitting in a real-world setting and to concurrently measure downstream CVD-related biological mechanisms. The WorkWell study design is informed by and will contribute to the translational application of circadian biology.
Aim 1. Assess the study feasibility and participant acceptability of delivering three behavioral strategies (avoiding dietary intake after 8p; blocking blue-light exposure after 8p; and breaking up prolonged sitting with standing after 5p) to reduce negative health exposures associated with rSST over two-week conditions in a randomized crossover study design.
Aim 2. Assess protocol compliance and participant acceptability of a suite of wearable sensors and home-based technologies during the feasibility trial.
Aim 3. Assess the preliminary efficacy and estimate effect size of the three behavioral strategies for improving postprandial glucose metabolism (primary focus on post-dinner meal, postprandial period), related 24-hr behaviors (sleep, other sedentary time, physical activity), heart rate variability, and circadian rhythms (sleep/wake activity rhythms, surface body temperature rhythms).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- This is a crossover trial where study participants will experience two conditions following a baseline usual behavior condition. All study participants will experience two of three following conditions: avoiding dietary intake after 8p; blocking blue-light exposure after 8p; and breaking up prolonged sitting with standing after 5p.
| Arm | Type | Receives |
|---|---|---|
| Blue light-Eating | Experimental | Behavioral: Blue light, Behavioral: EatingIntervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. Intervention 2: Participants will be encouraged to stop eating at 8pm. |
| Blue light-standing | Experimental | Behavioral: Blue light, Behavioral: StandingIntervention 1: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. |
| Eating-Standing | Experimental | Behavioral: Eating, Behavioral: StandingIntervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. |
| Eating-Blue Light | Experimental | Behavioral: Blue light, Behavioral: EatingIntervention 1: Participants will be encouraged to stop eating at 8pm. Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. |
| Standing-Blue Light | Experimental | Behavioral: Blue light, Behavioral: StandingIntervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. Intervention 2: Participants will be encouraged to wear blue light blocking glasses at 8pm until bed time. |
| Standing-Eating | Experimental | Behavioral: Eating, Behavioral: StandingIntervention 1: Participants will be sent notifications each hour on the hour from 5pm until bed time to stand for 10 minutes that hour. Intervention 2: Participants will be encouraged to stop eating at 8pm. |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥26 years of age
- BMI ≥ 27 kg/m2*; ≥25 kg/m2, if Asian (full or multiple race)**
- Insufficiently active (per US National Guidelines for Physical Activity of 150 minutes of MVPA/Week)
- Reporting an average of ≥3 hours of recreational sedentary screen time (rSST) per day, that usually extends at least until 9:00pm.
- On a typical night, consumes calories (food and/or drink) after 8:00pm.
Key exclusion criteria (20 listed)
- Conditions related to sleep disruption, including lactation, pregnancy, mid-night care providers, sleep disorders, severe sleep apnea
- History of hypoglycemia
- Pacemaker
- Caffeine consumption in excess and/or after 5pm (excess equals >4 cups of coffee per day or equivalent)
- Involvement in other physical activity, diet, or weight loss programs/studies
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 |
|---|---|---|
| Blue lightBlue light blocking glasses use and discouraged late night eating. | Behavioural | Blue light-Eating, Blue light-standing, Eating-Blue Light, Standing-Blue Light |
| EatingEncouraged not to eat past 8pm. | Behavioural | Blue light-Eating, Eating-Blue Light, Eating-Standing, Standing-Eating |
| StandingEncouraged to stand for 10 minutes per hour each out from 5pm to bed time. | Behavioural | Blue light-standing, Eating-Standing, Standing-Blue Light, Standing-Eating |
Primary outcome
Treatment acceptability
Time frame: 2 weeks
Intervention acceptability will be assessed using the Treatment Evaluation Questionnaire (TEQ) to measure acceptability of the three experimental conditions following the completion of each condition. Scale Range: 0 to 4. Higher scores indicate greater acceptability.
Changes in Evening Sedentary Screen Time
Time frame: 2 weeks
Minutes per week of screen time after 5p as measured by WatchWell app and activPAL
Change in evening postprandial glycemic control (5pm - 5am)
Time frame: 2 weeks
Participants will be asked to wear the Dexcom G6 Pro continuous glucose monitor during baseline and experimental conditions. Glycemic control will be calculated by averaging all glucose readings from 5pm - 5am during each of the conditions.
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 1 Oct 2026.
- 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.
Dorothy Sears, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light, Eating and Standing in people with Sedentary Time and Cardiovascular Diseases, 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 11 inclusion and 20 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 1 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 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?
Treatment acceptability (time frame: 2 weeks). The study lists 3 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 1 Oct 2026.