Physical Activity
Conditions
Keywords
physical activity, women, sedentary, accelerometer, text message, group meeting, personal call, workplace, cost-effectiveness, Sequential Multiple Assignment Randomized Trial, adaptive intervention, Actigraph, Fitbit, iCardia
Brief summary
This study employs a Sequential Multiple Assignment Randomized Trial (SMART) and aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity and improve cardiovascular health among sedentary employed women.
Detailed description
The long-term goal of this research program is to develop cost-effective strategies to increase moderate- intensity physical activity among sedentary women. Fewer than half of U.S. women meet recommendations for moderate-intensity physical activity, and thereby are at increased risk for cardiovascular disease. When provided a physical activity program, between 25-60% of women either fail to adopt it or fail to adhere after six months. Physical activity health benefits are further negatively impacted by the fact that sedentary behavior at many worksites exacerbates low physical activity. Among efficacious treatments for increasing physical activity for women, four have had promising results: (1) enhanced physical activity monitor treatment (PA monitor with goal setting and a physical activity prescription); (2) motivational text messages; (3) motivational personal calls; and (4) group meetings. While each of these treatments has proven efficacy, they differ on resource use and cost, and there is heterogeneity in response. When treatments have heterogeneity of response, adaptive interventions can help close that gap. Adaptive interventions start with an initial treatment and then transition to an augmented treatment for non-responders. This study aims to determine the most effective adaptive intervention combining four efficacious treatments (enhanced physical activity monitor, motivational text messages, motivational personal calls, group meetings) to increase physical activity (step counts per day, minutes moderate/vigorous physical activity per week) and improve cardiovascular health (aerobic fitness, body composition) among sedentary employed women. The investigators will also assess treatment effects on intervention targets (physical activity benefits, physical activity barriers, physical activity self-efficacy, and social support). A Sequential Multiple Assignment Randomized Trial (SMART) design will address the following aims: 1) Among non-responders to the initial treatments (enhanced physical activity monitor and enhanced physical activity monitor+ motivational text messages), compare the two augmented treatments (motivational personal calls and group meetings); 2a) Compare the two initial treatments and; 2b) Compare the four adaptive interventions embedded in the SMART on physical activity and cardiovascular health; 3) Identify mediators and moderators of the initial and augmented treatments on physical activity and cardiovascular health; 4) Compare the cost-effectiveness of the four adaptive interventions from the societal perspective which includes both program costs and participant costs. The investigators will recruit 312 sedentary women, aged 18 to 70, who are employed at a large urban academic medical center. Data will be collected on physical activity (self- report, device), cardiovascular health, physical activity benefits, physical activity barriers, physical activity self-efficacy, social support, and program and participant costs. Data will be collected at baseline, weeks 9-10 (when response to initial treatment is assessed), weeks 35-36, and weeks 51-52. The investigators expect to identify an optimal adaptive intervention for improving physical activity and cardiovascular health that minimizes costs and burden to women who respond to less intensive treatments, while maximizing benefits for those who need a more intensive approach.
Interventions
The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor.
The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor. In addition, these participants will receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent.
Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34.
Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34.
Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent. In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34.
Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment. The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34. In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent. In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34.
During Weeks 35-50, all women will receive enhanced physical activity monitors only.
Sponsors
Study design
Intervention model description
A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
Eligibility
Inclusion criteria
* Female employee at study site * Aged 18 to 70 * Able to speak/read English * Owns a smartphone with text messaging capability * Willing to receive text messages at the proposed pace * We will include participants who have Type 1 diabetes, or Type 2 diabetes with an A1C ≥ 9.0%, or have an A1C of ≥ 6.5% without a prior diabetes diagnosis, only if they have been given clearance by their health care provider * Without a disability that inhibits walking as determined by the PAR-Q & You (Physical Activity Readiness Questionnaire)
Exclusion criteria
* Major signs/symptoms of pulmonary or cardiovascular disease * Systolic BP ≥ 160 and/or diastolic BP ≥ 100 * Sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day (somewhat active)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity-Steps | Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps. | Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week. |
| Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA. | Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Health (1) | Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness. | Aerobic fitness: participants step in place to a predesignated height for 2 minutes and the average number of steps taken in 2 minutes are counted. |
| Cardiovascular Health (2) | Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI. | Body composition: Average BMI (weight measured in pounds; height measured in inches) was measured utilizing BMI calculation formula: BMI = Weight (kg) / Height (m)² |
| Cardiovascular Health (3) | Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement. | Body composition: Average waist circumference was measured in inches. |
Countries
United States
Participant flow
Recruitment details
Response to reviewer's comment #2- Each arm includes a specific title and time period. For Column #7 during the maintenance period, a total of 301 participants were analyzed. If we were to include 301 again in this column, the total would add up to 602, which would count the same participants twice. To avoid the double-counting and to keep the total participant number as 301, I've added column #7 but entered n as 0 in the maintenance period column. Comment #3. Response: footnote removed
Pre-assignment details
Excluded: 453 * Unable to be reached: 163 * Not Interested: 193 * Ineligible: 97 * failed phone screening: 14 * failed health screening: 33 * failed physical activity screening: 50
Participants by arm
| Arm | Count |
|---|---|
| Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor Only Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor only: In this group, participants were randomly assigned to an enhanced physical activity monitor only, which included Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor-only treatment group. | 149 |
| Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor + Text Messages Step1: Initial Treatment (weeks 1-8) enhanced physical activity monitor +motivational text messaging: In this group, participants were randomly assigned to an enhanced physical activity monitor (Fitbit with goal setting, a physical activity prescription, and self-monitoring of daily steps) + text messages. For baseline characteristics, this step includes both responders and non-responders from the physical activity monitor + text messages treatment group. | 152 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | dropped before the intervention | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 4 | 3 | 3 | 5 | 2 | 3 |
Baseline characteristics
| Characteristic | Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor Only | Step1: Initial Treatment (Weeks 1-8) Enhanced Physical Activity Monitor + Text Messages | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 149 Participants | 152 Participants | 301 Participants |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 11.6 | 46.1 years STANDARD_DEVIATION 11.2 | 45.6 years STANDARD_DEVIATION 11.4 |
| Average daily minutes of moderate/vigorous PA (MVPA) | 13.5 Number pf MVPA minutes/day (M, 95% CI) | 13.7 Number pf MVPA minutes/day (M, 95% CI) | 13.6 Number pf MVPA minutes/day (M, 95% CI) |
| Average daily steps | 4913.95 Number of steps (M, 95% CI) | 5082.05 Number of steps (M, 95% CI) | 4998 Number of steps (M, 95% CI) |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 16 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 44 Participants | 48 Participants | 92 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 14 Participants | 34 Participants |
| Race (NIH/OMB) White | 78 Participants | 74 Participants | 152 Participants |
| Region of Enrollment United States | 149 participants | 152 participants | 301 participants |
| Sex: Female, Male Female | 149 Participants | 152 Participants | 301 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 81 | 0 / 38 | 0 / 35 | 0 / 35 | 0 / 36 |
| other Total, other adverse events | 3 / 76 | 0 / 81 | 0 / 38 | 0 / 35 | 0 / 35 | 0 / 36 |
| serious Total, serious adverse events | 0 / 76 | 0 / 81 | 0 / 38 | 0 / 35 | 0 / 35 | 0 / 36 |
Outcome results
Physical Activity- Moderate to Vigorous Physical Activity (MVPA)
Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.
Population: Total N=301 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Physical Activity Monitor Only | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 17.4 Number of MVPA minutes/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 18.0 Number of MVPA minutes/day |
| Enhanced Physical Activity Monitor Only+ Personal Calls | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 18.8 Number of MVPA minutes/day |
| Enhanced Physical Activity Monitor Only+ Group Meetings | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 17.9 Number of MVPA minutes/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 18.6 Number of MVPA minutes/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings | Physical Activity- Moderate to Vigorous Physical Activity (MVPA) | 17.7 Number of MVPA minutes/day |
Physical Activity-Steps
Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.
Population: Total N=301 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Physical Activity Monitor Only | Physical Activity-Steps | 5637.2 Number of steps/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages | Physical Activity-Steps | 5863.3 Number of steps/day |
| Enhanced Physical Activity Monitor Only+ Personal Calls | Physical Activity-Steps | 5603.9 Number of steps/day |
| Enhanced Physical Activity Monitor Only+ Group Meetings | Physical Activity-Steps | 5631.6 Number of steps/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls | Physical Activity-Steps | 5636.7 Number of steps/day |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings | Physical Activity-Steps | 5322.0 Number of steps/day |
Cardiovascular Health (1)
Aerobic fitness: participants step in place to a predesignated height for 2 minutes and the average number of steps taken in 2 minutes are counted.
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.
Population: Total N=301 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Physical Activity Monitor Only | Cardiovascular Health (1) | 85.7 Number of steps/2 minutes |
| Enhanced Physical Activity Monitor+ Motivational Text Messages | Cardiovascular Health (1) | 87.1 Number of steps/2 minutes |
| Enhanced Physical Activity Monitor Only+ Personal Calls | Cardiovascular Health (1) | 86.3 Number of steps/2 minutes |
| Enhanced Physical Activity Monitor Only+ Group Meetings | Cardiovascular Health (1) | 89.9 Number of steps/2 minutes |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls | Cardiovascular Health (1) | 86 Number of steps/2 minutes |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings | Cardiovascular Health (1) | 88.7 Number of steps/2 minutes |
Cardiovascular Health (2)
Body composition: Average BMI (weight measured in pounds; height measured in inches) was measured utilizing BMI calculation formula: BMI = Weight (kg) / Height (m)²
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.
Population: Total N=301 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Physical Activity Monitor Only | Cardiovascular Health (2) | 31.8 weight (pounds)/height (Inches)^2x703 |
| Enhanced Physical Activity Monitor+ Motivational Text Messages | Cardiovascular Health (2) | 32.4 weight (pounds)/height (Inches)^2x703 |
| Enhanced Physical Activity Monitor Only+ Personal Calls | Cardiovascular Health (2) | 31.3 weight (pounds)/height (Inches)^2x703 |
| Enhanced Physical Activity Monitor Only+ Group Meetings | Cardiovascular Health (2) | 31.6 weight (pounds)/height (Inches)^2x703 |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls | Cardiovascular Health (2) | 32.2 weight (pounds)/height (Inches)^2x703 |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings | Cardiovascular Health (2) | 32.1 weight (pounds)/height (Inches)^2x703 |
Cardiovascular Health (3)
Body composition: Average waist circumference was measured in inches.
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.
Population: Total N=301 participants were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Enhanced Physical Activity Monitor Only | Cardiovascular Health (3) | 38.1 Inches |
| Enhanced Physical Activity Monitor+ Motivational Text Messages | Cardiovascular Health (3) | 38.7 Inches |
| Enhanced Physical Activity Monitor Only+ Personal Calls | Cardiovascular Health (3) | 38.4 Inches |
| Enhanced Physical Activity Monitor Only+ Group Meetings | Cardiovascular Health (3) | 39 Inches |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Personal Calls | Cardiovascular Health (3) | 39.8 Inches |
| Enhanced Physical Activity Monitor+ Motivational Text Messages+ Group Meetings | Cardiovascular Health (3) | 38.7 Inches |