Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

• ClinicalTrials.gov Identifier: NCT01280812
• Recruitment Status: Completed
• First Posted: January 21, 2011
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); American Heart Association
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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: Control (pedometer only)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Applying Mobile Persuasive Technologies to Increase Physical Activity in Women
• Study Start Date: February 2011
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
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: Control (pedometer only); This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.

Outcome Measures

Primary Outcome Measures :

1. Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps [ Time Frame: Baseline, 3, and 9 months ]
   This Omron Active Style Pro HJA-350IT comes with a USB Connection and 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) 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.
2. Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day) [ Time Frame: Baseline, 3 and 9 months ]
   This Omron Active Style Pro HJA-350IT comes with a USB Connection and 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) 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.

Secondary Outcome Measures :

1. Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR) [ Time Frame: Baseline, 3 and 9 months ]

   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 several physical activity indexes (minutes of exercise at each level of exercise intensity, number of days exercised, and a rough estimate of caloric expenditure over the week).

   PAR estimates both work-related and non work-related physical activity and higher number indicates greater activity.

2. Modified Self-Efficacy for Physical Activity Survey [ Time Frame: Baseline, 3 and 9 months ]
   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.
3. Social Support for Physical Activity (Family) [ Time Frame: Baseline, 3 and 9 months ]
   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. 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.
4. Social Support for Physical Activity (Friends) [ Time Frame: Baseline, 3 and 9 months ]
   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. 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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 69 Years (Adult, Older Adult)
• Sexes 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

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01280812
• Other Study ID Numbers: P0031274; 5R01HL104147-02 ( U.S. NIH Grant/Contract )
• First Posted: January 21, 2011
• Results First Posted: September 23, 2020
• Last Update Posted: September 23, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of California, San Francisco:

mobile phone; physical activity; women; maintenance; health promotion; prevention