- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280812
Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94118
- University of California San Francisco (Laurel Heights)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PA intervention and Maintenance plus
3-month physical activity intervention and 6-month maintenance intervention-Plus program
|
This group will receive a mobile phone software program and a pedometer.
Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips.
Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
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Experimental: PA intervention and Maintenance regular
3-month physical activity intervention and 6-month maintenance - Regular program
|
This group will receive a mobile phone software program and a pedometer.
Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips.
Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
|
Active Comparator: Pedometer
Non-intervention group
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This group will receive a pedometer.
Over a 9-month period, participants in this group will be asked to wear a pedometer.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 USB Connection and 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) 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.
|
Baseline, 3, and 9 months
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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 USB Connection and 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) 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.
|
Baseline, 3 and 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
Time Frame: Baseline, 3 and 9 months
|
An interviewer-administered 7-day physical activity recall (PAR) is used to assess physical activities performed during the week preceding each visit. The PAR is a widely used and well-validated self-report recall instrument that assesses the frequency, duration, and intensity of physical activity. It yields several physical activity indexes (minutes of exercise at each level of exercise intensity, number of days exercised, and a rough estimate of caloric expenditure over the week). PAR estimates both work-related and non work-related physical activity and higher number indicates greater activity. |
Baseline, 3 and 9 months
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Modified Self-Efficacy for Physical Activity Survey
Time Frame: Baseline, 3 and 9 months
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The Self-Efficacy for Physical Activity will be used to measure how confident the participant is to engage in physical activity in a specific situation.
A sample item is, "I am confident I can participate in regular physical activity when I am tired."
The measure consists of five items on a scale of 1 to 5, "1" being "not at all confident" and "5" being "very confident."
The possible range of scores is from 5 to 25 points.
Higher scores indicate higher self-efficacy for physical activity.
Reported internal consistency ranges from 0.78 to 0.82.
This measure has been widely used in adult women and men.
Based on our pilot study, we added one additional question to this survey.
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Baseline, 3 and 9 months
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Social Support for Physical Activity (Family)
Time Frame: Baseline, 3 and 9 months
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The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months.
The measure comprises two subscales (friend and family support subscales).
Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often").
The ratings of all 12 items are summed for a subtotal score.
Internal consistency (Cronbach's alpha) of the measure was 0.83 in previous studies.
Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales.
Reported internal consistencies ranged between 0.80 to 0.93 for both scales.
|
Baseline, 3 and 9 months
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Social Support for Physical Activity (Friends)
Time Frame: Baseline, 3 and 9 months
|
The Social Support and Exercise Survey will be used to measure both friend and family social support related to physical activity during the past three months.
The measure comprises two subscales (friend and family support subscales).
Each subscale has 12 items with 5-point Likert scales (ranging from 1, "none" to 5, "very often").
The ratings of all 12 items are summed for a subtotal score.
Internal consistency (Cronbach's alpha) of the measure was 0.83 in previous studies.
Test-retest reliabilities of the measure have ranged from 0.79 to 0.90 for both scales.
Reported internal consistencies ranged between 0.80 to 0.93 for both scales.
|
Baseline, 3 and 9 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Yoshimi Fukuoka, Ph.D., University of California, San Francisco
Publications and helpful links
General Publications
- Fukuoka Y, Komatsu J, Suarez L, Vittinghoff E, Haskell W, Noorishad T, Pham K. The mPED randomized controlled clinical trial: applying mobile persuasive technologies to increase physical activity in sedentary women protocol. BMC Public Health. 2011 Dec 14;11:933. doi: 10.1186/1471-2458-11-933.
- Fukuoka Y, Gay C, Haskell W, Arai S, Vittinghoff E. Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial. JMIR Mhealth Uhealth. 2015 Apr 13;3(2):e34. doi: 10.2196/mhealth.3928.
- Fukuoka Y, Haskell W, Vittinghoff E. New insights into discrepancies between self-reported and accelerometer-measured moderate to vigorous physical activity among women - the mPED trial. BMC Public Health. 2016 Aug 11;16(1):761. doi: 10.1186/s12889-016-3348-7.
- Lindgren T, Hooper J, Fukuoka Y. Perceptions and Experiences of Women Participating in a Digital Technology-Based Physical Activity Intervention (the mPED Trial): Qualitative Study. JMIR Public Health Surveill. 2019 Dec 20;5(4):e13570. doi: 10.2196/13570.
- Zhou M, Fukuoka Y, Goldberg K, Vittinghoff E, Aswani A. Applying machine learning to predict future adherence to physical activity programs. BMC Med Inform Decis Mak. 2019 Aug 22;19(1):169. doi: 10.1186/s12911-019-0890-0.
- Fukuoka Y, Haskell W, Lin F, Vittinghoff E. Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women: The mPED Randomized Clinical Trial. JAMA Netw Open. 2019 May 3;2(5):e194281. doi: 10.1001/jamanetworkopen.2019.4281.
- Fukuoka Y, Lindgren TG, Mintz YD, Hooper J, Aswani A. Applying Natural Language Processing to Understand Motivational Profiles for Maintaining Physical Activity After a Mobile App and Accelerometer-Based Intervention: The mPED Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10042. doi: 10.2196/10042.
- Fukuoka Y, Zhou M, Vittinghoff E, Haskell W, Goldberg K, Aswani A. Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis. JMIR Public Health Surveill. 2018 Feb 1;4(1):e10. doi: 10.2196/publichealth.9138.
- Fukuoka Y, Lisha NE, Vittinghoff E. Comparing Asian American Women's Knowledge, Self-Efficacy, and Perceived Risk of Heart Attack to Other Racial and Ethnic Groups: The mPED Trial. J Womens Health (Larchmt). 2017 Sep;26(9):1012-1019. doi: 10.1089/jwh.2016.6156. Epub 2017 Apr 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P0031274
- 5R01HL104147-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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