Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Heart Association
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01280812
First received: November 23, 2010
Last updated: June 9, 2014
Last verified: June 2014
  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

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
American Heart Association
Investigators
Principal Investigator: Yoshimi Fukuoka, Ph.D. University of California, San Francisco
  More Information

Publications:
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 October 22, 2014