NCT03724474

SMART Technology to Promote Heart Health in Midlife Adults

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Physical Activity
• Poor Quality Sleep
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Be SMART	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).

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-05-01
• Completion: 2020-08-01
• First posted: 2018-10-30
• Last updated: 2018-10-30