Applying Mobile Persuasive Technologies to Increase Physical Activity in Women

Conditions

Physical Activity, Sedentary Lifestyle

Keywords

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

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.

Teri Lindgren, Julie Hooper, Yoshimi Fukuoka

JMIR Public Health and Surveillance2019-09-0624 citations

10.2196/13570

Applying machine learning to predict future adherence to physical activity programs.

Zhou M, Fukuoka Y, Goldberg K, Vittinghoff E, Aswani A.

2019-08-2225 citations

10.1186/s12911-019-0890-0

Short- and Long-term Effects of a Mobile Phone App in Conjunction With Brief In-Person Counseling on Physical Activity Among Physically Inactive Women

Yoshimi Fukuoka, William L. Haskell, Feng Lin, Eric Vittinghoff

JAMA Network Open2019-05-2480 citations

10.1001/jamanetworkopen.2019.4281

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

Yoshimi Fukuoka, Teri Lindgren, Yonatan Mintz, Julie Hooper, Anil Aswani

JMIR mhealth and uhealth2018-04-2431 citations

10.2196/10042

Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis

Yoshimi Fukuoka, Mo Zhou, Eric Vittinghoff, William L. Haskell, Ken Goldberg et al. (6 authors)

JMIR Public Health and Surveillance2018-02-0138 citations

10.2196/publichealth.9138

New insights into discrepancies between self-reported and accelerometer-measured moderate to vigorous physical activity among women - the mPED trial.

Fukuoka Y, Haskell W, Vittinghoff E.

2016-08-1136 citations

10.1186/s12889-016-3348-7

Identifying Factors Associated With Dropout During Prerandomization Run-in Period From an mHealth Physical Activity Education Study: The mPED Trial

Yoshimi Fukuoka, Caryl Gay, William L. Haskell, Shoshana Arai, Eric Vittinghoff

JMIR mhealth and uhealth2015-04-1357 citations

10.2196/mhealth.3928

Interventions

BEHAVIORALMobile 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.

BEHAVIORALMobile 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.

BEHAVIORALControl (pedometer only)

This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 69 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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 Universal Serial Bus (USB) Connection and personal computer (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) metabolic equivalents (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 Universal Serial Bus (USB) Connection and personal computer (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) metabolic equivalents (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

Measure	Time frame	Description
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 average kcal/kg/day.
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 (possible ranges from 12 to 60). 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. Higher scores indicate greater support.
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 (possible ranges from 12 to 60). 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
PA Intervention and Maintenance Plus 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.	70
PA Intervention and Maintenance Regular 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.	71
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.	69
Total	210

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	1	1
Overall Study	Withdrawal by Subject	2	1	0

Baseline characteristics

Characteristic	PA Intervention and Maintenance Plus	PA Intervention and Maintenance Regular	Pedometer	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	10 Participants	10 Participants	4 Participants	24 Participants
Age, Categorical Between 18 and 65 years	60 Participants	61 Participants	65 Participants	186 Participants
Age, Continuous	52.0 years STANDARD_DEVIATION 11.2	53.6 years STANDARD_DEVIATION 11.7	51.7 years STANDARD_DEVIATION 10.1	52.4 years STANDARD_DEVIATION 11
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	4 Participants	3 Participants	13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants	67 Participants	66 Participants	197 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	14 Participants	14 Participants	13 Participants	41 Participants
Race (NIH/OMB) Black or African American	4 Participants	4 Participants	9 Participants	17 Participants
Race (NIH/OMB) More than one race	4 Participants	7 Participants	9 Participants	20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	48 Participants	46 Participants	38 Participants	132 Participants
Region of Enrollment United States	70 participants	71 participants	69 participants	210 participants
Sex: Female, Male Female	70 Participants	71 Participants	69 Participants	210 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 70	0 / 71	0 / 69
other Total, other adverse events	11 / 70	10 / 71	6 / 69
serious Total, serious adverse events	1 / 70	1 / 71	3 / 69

Outcome results

Primary

Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps

This Omron Active Style Pro HJA-350IT comes with a Universal Serial Bus (USB) Connection and personal computer (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) metabolic equivalents (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

Population: Intention to treat (ITT) analysis

Arm	Measure	Group	Value (MEAN)	Dispersion
PA Intervention and Maintenance Plus	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 3 months	8709 Steps/Day	Standard Deviation 3910
PA Intervention and Maintenance Plus	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at baseline	5837 Steps/Day	Standard Deviation 3235
PA Intervention and Maintenance Plus	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 9 months	7807 Steps/Day	Standard Deviation 4093
PA Intervention and Maintenance Regular	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at baseline	5063 Steps/Day	Standard Deviation 2526
PA Intervention and Maintenance Regular	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 3 months	8096 Steps/Day	Standard Deviation 3903
PA Intervention and Maintenance Regular	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 9 months	6909 Steps/Day	Standard Deviation 3704
Control	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at baseline	5384 Steps/Day	Standard Deviation 2920
Control	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 9 months	6265 Steps/Day	Standard Deviation 3524
Control	Accelerometer (Omron Active Style Pro HJA-350IT) Measured Daily Steps	Mean total daily steps at 3 months	6608 Steps/Day	Standard Deviation 3719

Comparison: Intent to treat analysisMixed Models Analysis

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 Universal Serial Bus (USB) Connection and personal computer (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) metabolic equivalents (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.