NCT01280812

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

September 23, 2020

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

4.2 years

First QC Date

November 23, 2010

Results QC Date

March 24, 2017

Last Update Submit

April 25, 2025

Conditions

Keywords

mobile phonephysical activitywomenmaintenancehealth promotionprevention

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, 3, and 9 months

  • 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.

    Baseline, 3 and 9 months

Secondary Outcomes (4)

  • 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

Study Arms (3)

PA intervention and Maintenance plus

EXPERIMENTAL

3-month physical activity intervention and 6-month maintenance intervention-Plus program

Behavioral: Mobile phone based physical activity intervention with maintenance plus

PA intervention and Maintenance regular

EXPERIMENTAL

3-month physical activity intervention and 6-month maintenance - Regular program

Behavioral: Mobile phone based physical activity intervention with maintenance regular

Pedometer

ACTIVE COMPARATOR

Non-intervention group

Behavioral: Control (pedometer only)

Interventions

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.

PA intervention and Maintenance regular

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.

PA intervention and Maintenance plus

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

Pedometer

Eligibility Criteria

Age25 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco (Laurel Heights)

San Francisco, California, 94118, United States

Location

Related Publications (9)

  • 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.

    PMID: 22168267BACKGROUND
  • 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.

    PMID: 25872754BACKGROUND
  • 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.

    PMID: 27514368BACKGROUND
  • 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.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Maintenance

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Results Point of Contact

Title
Yoshimi Fukuoka, PhD, RN, FAAN
Organization
UC San Francisco

Study Officials

  • Yoshimi Fukuoka, Ph.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2010

First Posted

January 21, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

April 29, 2025

Results First Posted

September 23, 2020

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations