Clinical trial NCT03724474: SMART Technology to Promote Heart Health in Midlife Adults
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Activity
Poor Quality Sleep
Hypertension
Keywords: Physical Activity
Sleep
Smartphones
Wearable Activity Monitors
Smart Coaches
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: Northern Arizona University
First posted: 2018-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Pretest-Posttest Control Group Design
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in weekly minutes of moderate-to-vigorous physical activity over 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
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