Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Step 1: PA Monitor
* Behavioral: Step 1: PA Monitor + Text
* Behavioral: Step 2: PA Monitor with Calls
* Behavioral: Step 2: PA Monitor with Meetings
* Behavioral: Step 2: PA Monitor + Texts with Calls
* Behavioral: Step 2: PA Monitor + Texts with Meetings
* Behavioral: Step 3: PA Monitor


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step1: Initial Treatment<br>Participants will be randomly assigned to one of the two initial treatment components: a) enhanced physical activity monitor only (physical activity monitor with goal setting and a physical activity prescription) treatment, or b) enhanced physical activity monitor+ motivational text messaging treatment for 8 weeks (early adoption phase). All participants will be given a physical activity step goal The initial treatment time period is from Weeks 1-8. | Behavioral: Step 1: PA Monitor<br>* 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.<br>Behavioral: Step 1: PA Monitor + Text<br>* 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.<br>|
| Experimental: Step 2: Augmented Treatment<br>At Week 8, it will be determined if a women has met her physical activity step goal. If she has, then she will be classified as a responder, and will continue with the same initial treatment component for weeks 9-34 (later adoption). If a woman has not met her physical activity step goal she will be classified as a non-responder. In addition to the initial treatment component non-responders to initial treatments will be randomly assigned to one of two augmented treatment components: a) personal calls, or b) group meetings for Weeks 9-34 (later adoption phase). | Behavioral: Step 2: PA Monitor with Calls<br>* 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.<br>Behavioral: Step 2: PA Monitor with Meetings<br>* 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.<br>Behavioral: Step 2: PA Monitor + Texts with Calls<br>* 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.<br>Behavioral: Step 2: PA Monitor + Texts with Meetings<br>* 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.<br>|
| Experimental: Step 3: Maintenance<br>At Weeks 35-50 (maintenance phase) all participants in the study return to an enhanced physical activity monitor only treatment component. | Behavioral: Step 3: PA Monitor<br>* During Weeks 35-50, all women will receive enhanced physical activity monitors only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity-Steps | Daily steps measured with ActiGraph | Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 | 
| Physical activity-MVPA | Minutes of moderate-to-vigorous physical activity/week measured with ActiGraph | Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular health (1) | Aerobic fitness: participants step in place to a predesignated height for 2 minutes | Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 | 
| Cardiovascular health (2) | Body composition: BMI (weight measured in pounds; height measured in inches) | Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 | 
| Cardiovascular health (3) | Body composition: waist measured in inches | Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adaptive intervention, Actigraph, Fitbit, iCardia, physical activity, women, sedentary, accelerometer, text message, group meeting, personal call, workplace, cost-effectiveness, Sequential Multiple Assignment Randomized Trial