Clinical trial NCT01280812: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Official title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Physical Activity
Keywords: mobile phone
physical activity
women
maintenance
health promotion
prevention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Heart Association
First posted: 2011-01-21
Enrollment: 210
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps
timeFrame: Baseline, 3, and 9 months
measure: Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)
timeFrame: Baseline, 3 and 9 months
Secondary outcomes:
measure: Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
timeFrame: Baseline, 3 and 9 months
measure: Modified Self-Efficacy for Physical Activity Survey
timeFrame: Baseline, 3 and 9 months
measure: Social Support for Physical Activity (Family)
timeFrame: Baseline, 3 and 9 months
measure: Social Support for Physical Activity (Friends)
timeFrame: Baseline, 3 and 9 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco (Laurel Heights)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Yoshimi Fukuoka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.