Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT01280812
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), American Heart Association (Other)
• Enrollment: 210
• Location: 1
• Arms: 3
• Duration (Months): 49.9
• Patients Per Site Per Month: 4.2

Study Details

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)	N/A

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
• 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: Feb 1, 2011
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 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 [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) [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) [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 [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) [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) [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

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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
• Other Study ID Numbers: P0031274; 5R01HL104147-02
• First Posted: Jan 21, 2011
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of California, San Francisco: mobile phone; physical activity; women; maintenance; health promotion; prevention

Study Results

Participant Flow

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Pedometer
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Period Title: Overall Study
STARTED	70	71	69
COMPLETED	67	69	68
NOT COMPLETED	3	2	1

Baseline Characteristics

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Pedometer	Total
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.	Total of all reporting groups
Overall Participants	70	71	69	210
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	60 85.7%	61 85.9%	65 94.2%	186 88.6%
>=65 years	10 14.3%	10 14.1%	4 5.8%	24 11.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.0 (11.2)	53.6 (11.7)	51.7 (10.1)	52.4 (11.0)
Sex: Female, Male (Count of Participants)
Female	70 100%	71 100%	69 100%	210 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 8.6%	4 5.6%	3 4.3%	13 6.2%
Not Hispanic or Latino	64 91.4%	67 94.4%	66 95.7%	197 93.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	14 20%	14 19.7%	13 18.8%	41 19.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	4 5.7%	4 5.6%	9 13%	17 8.1%
White	48 68.6%	46 64.8%	38 55.1%	132 62.9%
More than one race	4 5.7%	7 9.9%	9 13%	20 9.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	70 100%	71 100%	69 100%	210 100%

Outcome Measures

1. Primary Outcome

Title	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps
Description	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.
Time Frame	Baseline, 3, and 9 months

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Measure Participants	70	71	69
Mean total daily steps at baseline	5837 (3235)	5063 (2526)	5384 (2920)
Mean total daily steps at 3 months	8709 (3910)	8096 (3903)	6608 (3719)
Mean total daily steps at 9 months	7807 (4093)	6909 (3704)	6265 (3524)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PA Intervention and Maintenance Plus, PA Intervention and Maintenance Regular, Control
	Comments	Intent to treat analysis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Net)
	Estimated Value	1100
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 3000
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PA Intervention and Maintenance Plus, PA Intervention and Maintenance Regular, Control
	Comments	Intent to treat analysis.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	We use linear mixed models (LMMs) to assess effects of the interventions on trends in daily measurements of step counts, steps per hour, moderate physical activity, vigorous physical activity, and MVPA.
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1100
	Confidence Interval	(2-Sided) 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 3000
	Estimation Comments

2. Primary Outcome

Title	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Moderate to Vigorous Physical Activity (Minutes Per Day)
Description	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.
Time Frame	Baseline, 3 and 9 months

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT) analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Pedometer
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group 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.
Measure Participants	70	71	69
Mean Daily MVPA at baseline	43.5 (29.6)	38.0 (24.4)	45.7 (33.4)
Mean Daily MVPA at 3 months	67.6 (34.9)	61.6 (33.3)	53.0 (38.0)
Mean Daily MVPA at 9 months	60.1 (33.7)	56.6 (36.4)	50.8 (34.4)

3. Secondary Outcome

Title	Self-reported Physical Activity Measured by the 7-day Physical Activity Recall (PAR)
Description	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.
Time Frame	Baseline, 3 and 9 months

Outcome Measure Data

Analysis Population Description

Intention to treat analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Measure Participants	70	71	69
kcal/kg/day at baseline	33.1 (1.07)	32.9 (1.09)	32.9 (1.42)
kcal/kg/day at 3 months	34.5 (1.75)	34.8 (2.14)	33.7 (1.78)
kcal/kg/day at 9 months	34.3 (2.22)	33.8 (1.90)	34.1 (2.69)

4. Secondary Outcome

Title	Modified Self-Efficacy for Physical Activity Survey
Description	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.
Time Frame	Baseline, 3 and 9 months

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Measure Participants	70	71	69
Self-efficacy at baseline	19.0 (4.79)	19.8 (5.09)	18.8 (3.95)
Self-efficacy at 3 months	18.1 (4.50)	18.0 (5.13)	19.1 (5.53)
Self-efficacy at 9 months	18.3 (4.93)	17.8 (5.24)	19.2 (5.13)

5. Secondary Outcome

Title	Social Support for Physical Activity (Family)
Description	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.
Time Frame	Baseline, 3 and 9 months

Outcome Measure Data

Analysis Population Description

Intention to treat analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Measure Participants	70	71	69
PA social support from family at baseline	32.8 (9.16)	31.5 (10.9)	32.0 (9.18)
PA social support from family at 3 months	34.8 (10.7)	35.6 (11.2)	31.6 (9.94)
PA social support from family at 9 months	34.3 (11.1)	34.5 (9.86)	33.4 (11.0)

6. Secondary Outcome

Title	Social Support for Physical Activity (Friends)
Description	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.
Time Frame	Baseline, 3 and 9 months

Outcome Measure Data

Analysis Population Description

Intention to treat analysis

Arm/Group Title	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.	3-month physical activity intervention and 6-month maintenance - Regular program 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.	Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
Measure Participants	70	71	69
PA social support from friend at baseline	31.8 (8.11)	31.5 (8.21)	31.1 (8.91)
PA social support from friend at 3 months	34.7 (8.36)	35.1 (8.48)	31.1 (8.35)
PA social support from friend at 9 months	35.4 (9.17)	33.9 (9.17)	31.8 (8.74)

Adverse Events

Time Frame	9 months in total: -Intervention (Plus and Regular Groups) versus Control Group during the 3-month intervention period and the 6-month maintenance period.
Arm/Group Title	PA Intervention and Maintenance Plus		PA Intervention and Maintenance Regular		Control
Arm/Group Description	3-month physical activity intervention and 6-month maintenance intervention-Plus program 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.		3-month physical activity intervention and 6-month maintenance intervention regular program 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 stop using the app (activity diary).		Non-intervention group Pedometer only: This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
All Cause Mortality
	PA Intervention and Maintenance Plus		PA Intervention and Maintenance Regular		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/71 (0%)		0/69 (0%)
Serious Adverse Events
	PA Intervention and Maintenance Plus		PA Intervention and Maintenance Regular		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/70 (1.4%)		1/71 (1.4%)		3/69 (4.3%)
Gastrointestinal disorders
Hospitalization	0/70 (0%)	0	1/71 (1.4%)	1	0/69 (0%)	0
Infections and infestations
Hospitalization	1/70 (1.4%)	1	0/71 (0%)	0	0/69 (0%)	0
Musculoskeletal and connective tissue disorders
Hospitalization	0/70 (0%)	0	0/71 (0%)	0	1/69 (1.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization	0/70 (0%)	0	0/71 (0%)	0	2/69 (2.9%)	2
Reproductive system and breast disorders
Hospitalization	0/70 (0%)	0	0/71 (0%)	0	1/69 (1.4%)	1
Other (Not Including Serious) Adverse Events
	PA Intervention and Maintenance Plus		PA Intervention and Maintenance Regular		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/70 (15.7%)		10/71 (14.1%)		6/69 (8.7%)
Cardiac disorders
Emergency Department or Urgent Care Facility Visit	0/70 (0%)	0	0/71 (0%)	0	1/69 (1.4%)	1
Ear and labyrinth disorders
Emergency Department or Urgent Care Facility Visit	1/70 (1.4%)	1	1/71 (1.4%)	1	0/69 (0%)	0
Eye disorders
Emergency Department or Urgent Care Facility Visits	1/70 (1.4%)	1	0/71 (0%)	0	0/69 (0%)	0
Gastrointestinal disorders
Emergency Department or Urgent Care Facility Visit	0/70 (0%)	0	1/71 (1.4%)	1	3/69 (4.3%)	3
Infections and infestations
Emergency Department or Urgent Care Facility Visit	0/70 (0%)	0	1/71 (1.4%)	1	0/69 (0%)	0
Injury, poisoning and procedural complications
Emergency Department or Urgent Care Facility Visit	3/70 (4.3%)	4	3/71 (4.2%)	3	0/69 (0%)	0
Investigations
Emergency Department or Urgent Care Facility Visit	1/70 (1.4%)	1	0/71 (0%)	0	0/69 (0%)	0
Musculoskeletal and connective tissue disorders
Emergency Department or Urgent Care Facility Visit	5/70 (7.1%)	5	2/71 (2.8%)	2	1/69 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Emergency Department or Urgent Care Facility Visit	1/70 (1.4%)	1	1/71 (1.4%)	1	1/69 (1.4%)	1
Vascular disorders
Emergency Department or Urgent Care Facility Visit	0/70 (0%)	0	1/71 (1.4%)	1	0/69 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.