NCT03558828

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Physical Activity

Interventions

Type	Name	Description
BEHAVIORAL	Step 1: PA 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.
BEHAVIORAL	Step 1: PA Monitor + Text	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.
BEHAVIORAL	Step 2: PA Monitor with Calls	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.
BEHAVIORAL	Step 2: PA Monitor with Meetings	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.
BEHAVIORAL	Step 2: PA Monitor + Texts with Calls	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.
BEHAVIORAL	Step 2: PA Monitor + Texts with Meetings	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.
BEHAVIORAL	Step 3: PA Monitor	During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Timeline

• Start date: 2018-08-24
• Primary completion: 2023-08-28
• Completion: 2025-06-30
• First posted: 2018-06-15
• Last updated: 2025-08-03
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States