SMART Technology to Promote Heart Health in Midlife Adults

NCT03724474 | Unknown

• 1 other identifier: 1168721-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physical Activity; Poor Quality Sleep; Hypertension

Keywords

Physical Activity; Sleep; Smartphones; Wearable Activity Monitors; Smart Coaches

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Study Arms (2)

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.

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.

Behavioral: Be SMART

Interventions

Be SMART 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).

Be SMART Condition; Fitbit Only Condition

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead
• Northern Arizona University: collaborator

MeSH Terms

Conditions

Motor Activity; Hypertension

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Pretest-Posttest Control Group Design

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 30, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 30, 2018

Record last verified: 2018-10