SMART Technology to Promote Heart Health in Midlife Adults

NCT ID: NCT03724474

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2020-08-31

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.

Conditions

Physical Activity; Poor Quality Sleep; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Be SMART Condition

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.

Group Type: EXPERIMENTAL

Be SMART

Intervention Type: BEHAVIORAL

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).

Fitbit Only Condition

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.

Group Type: ACTIVE_COMPARATOR

Be SMART

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northern Arizona University

OTHER

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Greg Dominick

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1168721-1

Identifier Type: -

Identifier Source: org_study_id