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Sedentary LifestyleNCT01280812

Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

A study testing Mobile phone based physical activity intervention with maintenance plus and Mobile phone based physical activity intervention with maintenance regular in people with Sedentary Lifestyle and Physical Activity, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 69 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sedentary Lifestyle, Physical Activity
What is being tested?
Mobile phone based physical activity intervention with maintenance plus and Mobile phone based physical activity intervention with maintenance regular
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteUnited States
Study dates
Feb 2011to Apr 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 69 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California San Francisco (Laurel Heights)

    San Francisco, California, 94118

Other trials in United States

About this study

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.

Read the 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.

Being tested
Mobile phone based physical activity intervention with maintenance plus, Mobile phone based physical activity intervention with maintenance regular, Control (pedometer only)
Keywords
mobile phone, physical activity, women, maintenance, health promotion, prevention
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile phone based physical activity intervention with maintenance plusBehavioural

    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.

  • Mobile phone based physical activity intervention with maintenance regularBehavioural

    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.

  • Control (pedometer only)Behavioural

    This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.

Study groups in NCT01280812
Study groupRoleWhat they receive
PA intervention and Maintenance plusExperimental3-month physical activity intervention and 6-month maintenance intervention-Plus program
Receives: Behavioral: Mobile phone based physical activity intervention with maintenance plus
PA intervention and Maintenance regularExperimental3-month physical activity intervention and 6-month maintenance - Regular program
Receives: Behavioral: Mobile phone based physical activity intervention with maintenance regular
PedometerActive comparatorNon-intervention group
Receives: Behavioral: Control (pedometer only)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline, 3, and 9 months

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

    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.

    Measured: Baseline, 3 and 9 months

Secondary outcomes (4)
  1. Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)

    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 average kcal/kg/day.

    Measured: Baseline, 3 and 9 months

  2. Modified Self-Efficacy for Physical Activity Survey

    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.

    Measured: Baseline, 3 and 9 months

  3. Social Support for Physical Activity (Family)

    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 (possible ranges from 12 to 60). 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. Higher scores indicate greater support.

    Measured: Baseline, 3 and 9 months

  4. Social Support for Physical Activity (Friends)

    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 (possible ranges from 12 to 60). 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.

    Measured: Baseline, 3 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01280812
Sponsor's protocol ID
P0031274
Other IDs
5R01HL104147-02
Status last verified
Apr 2025
First submitted
23 Nov 2010
Last updated
29 Apr 2025
Data monitoring committee
Yes
Individual data sharing
No

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.

    PubMed 22168267
  • 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.

    PubMed 25872754
  • 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.

    PubMed 27514368
  • 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.

    PubMed 31859677
  • 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.

    PubMed 31438926
  • 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.

    PubMed 31125101
  • 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.

    PubMed 29925491
  • 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.

    PubMed 29391341
  • 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.

    PubMed 28418750

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone based physical activity intervention with maintenance plus and Mobile phone based physical activity intervention with maintenance regular in people with Sedentary Lifestyle and Physical Activity, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps (time frame: Baseline, 3, and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01280812, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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