Applying Mobile Persuasive Technologies to Increase Physical Activity in Women - Full Text View

Purpose

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.

Condition	Intervention
Sedentary Lifestyle Physical Activity	Behavioral: Mobile phone based physical activity intervention with maintenance plus Behavioral: Mobile phone based physical activity intervention with maintenance regular Behavioral: Pedometer only


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Physical activity measured by Omron Active Style Pro HJA-350IT [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-reported physical activity measured by the 7-day Physical Activity Recall [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Self-efficacy for physical activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Social support for physical activity [ Time Frame: 9 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	192
Study Start Date:	February 2011
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PA intervention and Maintenance plus 3-month physical activity intervention and 6-month maintenance intervention-Plus program	Behavioral: Mobile phone based physical activity intervention with maintenance plus 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.
Experimental: PA intervention and Maintenance regular 3-month physical activity intervention and 6-month maintenance - Regular program	Behavioral: Mobile phone based physical activity intervention with 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.
Active Comparator: Pedometer Non-intervention group	Behavioral: Pedometer only This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.

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


Ages Eligible for Study:	25 Years to 69 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280812

Locations


United States, California
University of California San Francisco (Laurel Heights)
San Francisco, California, United States, 94118

Sponsors and Collaborators

University of California, San Francisco

National Heart, Lung, and Blood Institute (NHLBI)

American Heart Association

Investigators


Principal Investigator:	Yoshimi Fukuoka, Ph.D.	University of California, San Francisco

More Information

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.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01280812 History of Changes
Other Study ID Numbers:	P0031274, 5R01HL104147-02
Study First Received:	November 23, 2010
Last Updated:	June 9, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:


mobile phone physical activity women	maintenance health promotion prevention

ClinicalTrials.gov processed this record on March 03, 2015