Physical ActivityBeSMARTNCT03724474
SMART Technology to Promote Heart Health in Midlife Adults
A study testing Be SMART in people with Physical Activity and Poor Quality Sleep, run by University of Delaware.
Trial summary
This study aims to increase weekly minutes of moderate-to-vigorous physical activity and improve sleep quality in a sample of mid-life adults between ages 50 and 64 years. Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Poor Quality Sleep, Hypertension
- What is being tested?
- Be SMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to Aug 2020
- 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 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 50-64 years of age
- Prehypertensive (120/80 mmHg - 139/89 mmHg) or stage 1 hypertensive (140/90 mmHg - 159/99 mmHg)
- Physically inactive (<100 minutes of MVPA in the previous week)
- Report insufficient sleep duration (<6 hours/night on >7 nights in the past month)
- Own a smartphone
- Non-smoker
Show all 11Show fewer
- No signs or symptoms of chronic disease
- Have no chronic pain
- Have no major depressive disorder, general anxiety disorder, or sleep disorder
- Do not work alternating day-night shifts
- Medical clearance obtained from individual's physician
Who cannot join
- Younger than 50 years; older than 64 years
- Not prehypertensive or blood pressure is >159/99 mmHg
- Physically active (>100 min of MVPA in the previous week)
- Report sufficient sleep duration (>6 hours/night on 7 or more nights in the past month)
- Does not own a smartphone
- Current smoker
Show all 11Show fewer
- Report signs/symptoms of chronic disease
- Experiences chronic pain
- Have major depressive disorder, general anxiety disorder, or sleep disorder
- Works alternating day and night shifts
- Medical clearance not obtained from individual's physician
About this study
Official title: Integrating Mobile and Wearable Technology to Promote Physical Activity and Sleep Among Midlife Adults: the Bio-Behavioral Systems to Motivate and Reinforce Heart Health (BeSMART) Trial
This study aims to increase weekly minutes of moderate-to-vigorous physical activity and improve sleep quality in a sample of mid-life adults between ages 50 and 64 years.
Read the detailed description
This 2-year study will develop, test, and refine a cloud-based feedback system, and evaluate the impact of a 3 month randomized controlled feasibility pilot intervention - the Bio-behavioral systems to Motivate and Reinforce Heart Health trial (Be SMART) on changes in moderate-to-vigorous physical activity (MVPA) and sleep among mid-life adults between ages 50 and 64 years.
Aim 1 will examine the acceptability of the Be SMART system. We will conduct a 6-week proof- of-concept study in 10 mid-life adults to specifically examine recruitment plausibility, adherence and attrition rates, satisfaction, and implementation fidelity.
Aim 2 will quantify the impact of the Be SMART intervention (n=30) on changes in MVPA and sleep metrics compared to a Fitbit-only condition (n=30) among mid-life adults (N=60). Hypothesis 2a: At 3 months, participants in the Be SMART condition will show significantly greater weekly minutes of MVPA compared to the Fitbit-only condition, controlling for baseline. Hypothesis 2b: At 3 months, participants in the Be SMART condition will be significantly more likely to report adequate sleep duration, shorter sleep latency, and earlier sleep timing, compared to the Fitbit-only condition, controlling for baseline.
Aim 3 will explore the extent to which changes in MVPA and sleep metrics impact blood pressure changes among mid-life adults (N=60). Secondly, this study will quantify the extent to which Be SMART participants (n=30) achieve their weekly goals and if goal achievement impacts changes in blood pressure at 3 months. Hypothesis 3a: Changes in MVPA and sleep metrics will be related to changes in blood pressure. Hypothesis 3b, the degree of goal achievement will be related to changes in blood pressure.
- Conditions
- Physical Activity, Poor Quality Sleep, Hypertension
- Being tested
- Be SMART
- Keywords
- Physical Activity, Sleep, Smartphones, Wearable Activity Monitors, Smart Coaches
- Medical subject headings
- Motor Activity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Be SMARTBehavioural
The behavioral intervention will examine 12-week changes in sleep metrics and physical activity, compared to baseline measures, between subjects randomly assigned to a treatment (Be SMART) and an active control (Fitbit Only) condition (n=30, respectively).
| Study group | Role | What they receive |
|---|---|---|
| Be SMART Condition | Experimental | Subjects randomly assigned to the Be SMART condition (n=30) will first meet with a credentialed health coach to help create personally relevant weekly, short-term (6-weeks) and long-term (12-weeks) PA and sleep goals, and an initial action and coping plan. At 6- weeks (study mid-point), Be SMART subjects will complete a short telephonic "booster" session with the health coach. Throughout the 12-week intervention, our agent-based feedback system will communicate weekly messages via short message service (SMS) based on their weekly goal achievement, informed by the continuous collection of their Fitbit data. In addition, subjects in the Be SMART condition will also take their morning blood pressure using a blue-tooth enabled device that wirelessly sends this data to the Be SMART server. Receives: Behavioral: Be SMART |
| Fitbit Only Condition | Active comparator | Subjects who are randomly assigned to the active control condition (n=30) will receive a Fitbit device and wireless blood pressure monitor (same as Be SMART condition). However, subjects in the Fitbit Only condition will not meet with a health coach for establishing SMART goals and creating an action/coping plan, nor will Fitbit Only subjects receive any feedback messages or prompts from the Be SMART server, although data from their Fitbit devices will be continuously collected throughout the q12 week intervention. Receives: Behavioral: Be SMART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly minutes of moderate-to-vigorous physical activity over 12 weeks
Participants will wear an accelerometer for 7 consecutive days at baseline and 12 weeks to assess physical activity intensity (e.g. light, moderate, vigorous)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Pretest-Posttest Control Group Design
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Arizona University
- Responsible party
- Principal investigator, Greg Dominick, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03724474
- Sponsor's protocol ID
- 1168721-1
- Acronym
- BeSMART
- Status last verified
- Oct 2018
- First submitted
- 4 Oct 2018
- Last updated
- 30 Oct 2018
- 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 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mobile and Wearable Technology to Promote Physical Activity and Sleep Among Midlife Adults: the Bio-Behavioral Systems to Motivate and Reinforce Heart Health (BeSMART) Trial
- ClinicalTrials.gov ID
- NCT03724474
- Acronym / sponsor ID
- BeSMART / 1168721-1
- Conditions
- Physical Activity, Poor Quality Sleep, Hypertension
- Keywords
- Physical Activity, Sleep, Smartphones, Wearable Activity Monitors, Smart Coaches
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Northern Arizona University
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 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.
This study aims to increase weekly minutes of moderate-to-vigorous physical activity and improve sleep quality in a sample of mid-life adults between ages 50 and 64 years.
Detailed description
This 2-year study will develop, test, and refine a cloud-based feedback system, and evaluate the impact of a 3 month randomized controlled feasibility pilot intervention - the Bio-behavioral systems to Motivate and Reinforce Heart Health trial (Be SMART) on changes in moderate-to-vigorous physical activity (MVPA) and sleep among mid-life adults between ages 50 and 64 years.
Aim 1 will examine the acceptability of the Be SMART system. We will conduct a 6-week proof- of-concept study in 10 mid-life adults to specifically examine recruitment plausibility, adherence and attrition rates, satisfaction, and implementation fidelity.
Aim 2 will quantify the impact of the Be SMART intervention (n=30) on changes in MVPA and sleep metrics compared to a Fitbit-only condition (n=30) among mid-life adults (N=60). Hypothesis 2a: At 3 months, participants in the Be SMART condition will show significantly greater weekly minutes of MVPA compared to the Fitbit-only condition, controlling for baseline. Hypothesis 2b: At 3 months, participants in the Be SMART condition will be significantly more likely to report adequate sleep duration, shorter sleep latency, and earlier sleep timing, compared to the Fitbit-only condition, controlling for baseline.
Aim 3 will explore the extent to which changes in MVPA and sleep metrics impact blood pressure changes among mid-life adults (N=60). Secondly, this study will quantify the extent to which Be SMART participants (n=30) achieve their weekly goals and if goal achievement impacts changes in blood pressure at 3 months. Hypothesis 3a: Changes in MVPA and sleep metrics will be related to changes in blood pressure. Hypothesis 3b, the degree of goal achievement will be related to changes in blood pressure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Pretest-Posttest Control Group Design
| Arm | Type | Receives |
|---|---|---|
| Be SMART Condition | Experimental | Behavioral: Be SMARTSubjects randomly assigned to the Be SMART condition (n=30) will first meet with a credentialed health coach to help create personally relevant weekly, short-term (6-weeks) and long-term (12-weeks) PA and sleep goals, and an initial action and coping plan. At 6- weeks (study mid-point), Be SMART subjects will complete a short telephonic "booster" session with the health coach. Throughout the 12-week intervention, our agent-based feedback system will communicate weekly messages via short message service (SMS) based on their weekly goal achievement, informed by the continuous collection of their Fitbit data. In addition, subjects in the Be SMART condition will also take their morning blood pressure using a blue-tooth enabled device that wirelessly sends this data to the Be SMART server. |
| Fitbit Only Condition | Active comparator | Behavioral: Be SMARTSubjects who are randomly assigned to the active control condition (n=30) will receive a Fitbit device and wireless blood pressure monitor (same as Be SMART condition). However, subjects in the Fitbit Only condition will not meet with a health coach for establishing SMART goals and creating an action/coping plan, nor will Fitbit Only subjects receive any feedback messages or prompts from the Be SMART server, although data from their Fitbit devices will be continuously collected throughout the q12 week intervention. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 50-64 years of age
- Prehypertensive (120/80 mmHg - 139/89 mmHg) or stage 1 hypertensive (140/90 mmHg - 159/99 mmHg)
- Physically inactive (<100 minutes of MVPA in the previous week)
- Report insufficient sleep duration (<6 hours/night on >7 nights in the past month)
- Own a smartphone
Key exclusion criteria (11 listed)
- Younger than 50 years; older than 64 years
- Not prehypertensive or blood pressure is >159/99 mmHg
- Physically active (>100 min of MVPA in the previous week)
- Report sufficient sleep duration (>6 hours/night on 7 or more nights in the past month)
- Does not own a smartphone
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 |
|---|---|---|
| Be SMARTThe behavioral intervention will examine 12-week changes in sleep metrics and physical activity, compared to baseline measures, between subjects randomly assigned to a treatment (Be SMART) and an active control (Fitbit Only) condition (n=30, respectively). | Behavioural | Be SMART Condition, Fitbit Only Condition |
Primary outcome
Change in weekly minutes of moderate-to-vigorous physical activity over 12 weeks
Time frame: 12 weeks
Participants will wear an accelerometer for 7 consecutive days at baseline and 12 weeks to assess physical activity intensity (e.g. light, moderate, vigorous)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Be SMART in people with Physical Activity and Poor Quality Sleep, run by University of Delaware.
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 11 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 weekly minutes of moderate-to-vigorous physical activity over 12 weeks (time frame: 12 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 30 Oct 2018.