A Micro-randomized Trial of HeartSteps, an mHealth Intervention for Increasing Physical Activity

NCT03225521 | Completed

• 2 other identifiers: HUM001031275R01HL125440
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

  30-minute window after each available decision point

  30 minutes

• Daily step count

  Daily step count on the day following treatment

  24 hour day

Secondary Outcomes (1)

• Thumbs up/down

  30-minute window while message is available

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. The randomization probability is 0.6 for receiving a message and 0.4 for not receiving a message. For activity planning, at each decision point, the participant is randomized to either receive evening planning or not at that decision time. The randomization probability for receiving planning is 0.5, and 0.5 for not receiving planning.

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

Interventions

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

HeartSteps is an Android-based mHealth intervention that contains two main intervention components: contextually-tailored suggestions for activity and planning of the next day's activity. Activity suggestions provide individuals with actionable suggestions for how they can be active in their current context. Delivered suggestions are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. HeartSteps can deliver a user activity suggestions up to five times a day. Evening planning asks users to create or choose a plan of how they will be active on the following day. Planning can be delivered once a day, in the evening.

HeartSteps intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English speakers,
• between 18 and 60 years of age,
• could walk for exercise without discomfort, and
• either had a full-time daytime job or a regular schedule outside the home (e.g., students)
• have a personal phone running Android 5.0 or higher or willing to use a study-provided phone as their primary phone for the duration of the study.

You may not qualify if:

• Need medical supervision to exercise
• Currently using an activity tracker (e.g., FitBit)

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (4)

• Boruvka A, Almirall D, Witkiewitz K, Murphy SA. Assessing Time-Varying Causal Effect Moderation in Mobile Health. J Am Stat Assoc. 2018;113(523):1112-1121. doi: 10.1080/01621459.2017.1305274. Epub 2017 Mar 29.

  PMID: 30467446 BACKGROUND

• Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.

  PMID: 26651463 BACKGROUND

• Liao P, Klasnja P, Tewari A, Murphy SA. Sample size calculations for micro-randomized trials in mHealth. Stat Med. 2016 May 30;35(12):1944-71. doi: 10.1002/sim.6847. Epub 2015 Dec 28.

  PMID: 26707831 BACKGROUND

• Klasnja P, Smith S, Seewald NJ, Lee A, Hall K, Luers B, Hekler EB, Murphy SA. Efficacy of Contextually Tailored Suggestions for Physical Activity: A Micro-randomized Optimization Trial of HeartSteps. Ann Behav Med. 2019 May 3;53(6):573-582. doi: 10.1093/abm/kay067.

  PMID: 30192907 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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: Each participant-time point is randomized between intervention or no intervention (delivery of a contextually tailored activity suggestion or no suggestion; planning or no planning)

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: July 18, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

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