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Clinical Trials/NCT01280812
NCT01280812CompletedNot Applicable

Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

University of California, San Francisco2 sites in 1 country210 target enrollmentStarted: February 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
210
Locations
2
Primary Endpoint
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps

Study Overview

Brief Summary

The primary purpose of this study is to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity compared to the control group.

Detailed Description

Physical inactivity is associated with increased risk of co-morbidity and premature mortality. Given the rapid growth of mobile phone technology and the increasing number of users, the investigators developed an interactive mobile phone-based physical activity intervention for sedentary women. The investigators propose to conduct a randomized, controlled trial to assess the efficacy of the mobile phone-based physical activity intervention on increasing physical activity over a 3-month period. 192 sedentary women will be randomized in a 2-to-1 ratio to a 3-month mobile phone-based physical activity intervention group or to a control group. To provide insight into how best to maximize the potential for sustained physical activity after completion of the 3-month program, women in the intervention group who complete the physical activity program will be further randomized into a 6-month maintenance intervention-PLUS program (pedometer plus mobile phone diary) or to a 6-month maintenance intervention-REGULAR program (pedometer only). Unlike a conventional maintenance follow-up in which all subjects continue in their respective randomization arms, re-randomizing subjects into either a maintenance intervention-REGULAR group or a maintenance intervention-PLUS group will allow us to examine the "dose-response" of the maintenance methods if the intervention is effective.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 69 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Sedentary lifestyle at work and/or during leisure time
  • Intend to be physically active
  • Female, age >25 to 69
  • Access to a home telephone or a mobile phone
  • Speak and read English

Exclusion Criteria

  • Known medical conditions or other physical problems that need special attention in an exercise program
  • Plan a trip abroad during the first 4 months of the study period.
  • Pregnant/Delivered a baby during the last 6 months
  • Known severe hearing or speech problem
  • Body Mass Index (BMI) > 43.0 kg/m2
  • Currently participate in lifestyle modification programs or research studies that may potentially confound the results of the study
  • History of bariatric surgery or future plans for bariatric surgery in the next 12 months

Outcomes

Primary Outcomes

Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps

Time Frame: Baseline, 3, and 9 months

This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.

Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)

Time Frame: Baseline, 3 and 9 months

This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (PC) Software. The Active Style Pro HJA-350IT can display daily steps. The advantage of using the Omron Active Style Pro HJA-350IT is that the Omron Active Style Pro HJA-350IT will automatically reset the step count every evening at midnight while still allowing participants to view the past 7 days of step counts. Another advantage of using this Omron Active Style Pro HJA-350IT is that a researcher can select 1 of 4 Omron Active Style Pro HJA-350IT screen displays: (1) Steps display only, (2) metabolic equivalents (MET) display only, (3) 24-hour clock display (does not show any physical activity information), and (4) Steps, MET, and weekly average activities during the last four weeks. Data from the most recent 150 days performance will also be automatically stored so they can be directly downloaded to a computer.

Secondary Outcomes

  • Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)(Baseline, 3 and 9 months)
  • Modified Self-Efficacy for Physical Activity Survey(Baseline, 3 and 9 months)
  • Social Support for Physical Activity (Family)(Baseline, 3 and 9 months)
  • Social Support for Physical Activity (Friends)(Baseline, 3 and 9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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