An mHealth Mobile Application Supporting Maintenance of Physical Activity Among Men and Women With High Blood Pressure

NCT03937674 | Completed DMC

• 1 other identifier: 1257484
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this research is to evaluate the efficacy of contextually tailored activity suggestions and activity planning for increasing physical activity among sedentary adults.

Conditions

Physical Activity

Keywords

Physical Activity; Mobile Health; Self Monitoring; Wearable Sensors; Tailored Health Communication; Implementation Intentions; Mobile Apps; Anti-Sedentary Behavior; Opportunistic Physical Activity; Health Belief Model

Outcome Measures

Primary Outcomes (2)

• 30 minute step count

  step count within the 30-minute window after each available decision point when activity suggestions are randomized. Assessed using the Fitbit Versa Activity tracker.

  30 minutes

• Daily step count

  Daily step count on the day of treatment. Assessed using the Fitbit Versa activity tracker.

  24 hours

Secondary Outcomes (1)

• MVPA

  24 hours

Study Arms (1)

HeartSteps Intervention

EXPERIMENTAL

For activity suggestions, at each available decision time, each participant is randomly assigned to either receive an activity suggestion or not.

Behavioral: HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults.

Interventions

HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults. BEHAVIORAL

HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.

HeartSteps Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Recent blood pressure readings that falls in the stage 1 hypertension range by new AHA/ACC guidelines \[\>= 130 systolic\]
• Owns an iPhone
• Able to walk for 10 minutes without pain
• Expresses desire during study screen to increase physical activity

You may not qualify if:

• Taking hypertension meds
• Any diagnosis where physical activity would be counterindicated
• Recent acute cardio vascular event
• Major psychiatric illness

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of Michigan: collaborator
• University of California, San Diego: collaborator
• Harvard University: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Pedja V Klasnja, PhD

  Kaiser Permente Washington Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At each "decision time"-a time point when an intervention component can be delivered-each day of the study each participant is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; morning motivational message or no motivational message)

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 6, 2019
• Study Start: May 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: December 4, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)