Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

Physical Activity Clinical Trial

Official title:

Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280812
• Other study ID #: P0031274
• Secondary ID: 5R01HL104147-02
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: September 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Sedentary Lifestyle

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of California San Francisco (Laurel Heights)	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	American Heart Association, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	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.	Baseline, 3, and 9 months
Primary	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 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.	Baseline, 3 and 9 months
Secondary	Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)	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.	Baseline, 3 and 9 months
Secondary	Modified Self-Efficacy for Physical Activity Survey	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.	Baseline, 3 and 9 months
Secondary	Social Support for Physical Activity (Family)	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.	Baseline, 3 and 9 months
Secondary	Social Support for Physical Activity (Friends)	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.	Baseline, 3 and 9 months