Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

Not Applicable

Completed

• Conditions: Sedentary Lifestyle; Physical Activity
• Interventions: Behavioral: Mobile phone based physical activity intervention with maintenance plus; Behavioral: Control (pedometer only); Behavioral: Mobile phone based physical activity intervention with maintenance regular

• Registration Number: NCT01280812
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-02
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-03-24
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Results First Posted: 2020-09-23
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PA intervention and Maintenance plus	Mobile phone based physical activity intervention with maintenance plus	3-month physical activity intervention and 6-month maintenance intervention-Plus program
Pedometer	Control (pedometer only)	Non-intervention group
PA intervention and Maintenance regular	Mobile phone based physical activity intervention with maintenance regular	3-month physical activity intervention and 6-month maintenance - Regular program

Primary Outcome Measures

Name	Time	Method
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	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.
Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)	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

Name	Time	Method
Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)	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.
Modified Self-Efficacy for Physical Activity Survey	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.
Social Support for Physical Activity (Family)	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.
Social Support for Physical Activity (Friends)	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.

Trial Locations

Locations (1)

University of California San Francisco (Laurel Heights); 🇺🇸 San Francisco, California, United States