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Completed

NCT Number: NCT03558828

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rush University College of Nursing

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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")

Treatment and study plan

Step 1: PA Monitor

Behavioral

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.

Step 1: PA Monitor + Text

Behavioral

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.

Step 2: PA Monitor with Calls

Behavioral

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.

Step 2: PA Monitor with Meetings

Behavioral

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.

Step 2: PA Monitor + Texts with Calls

Behavioral

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.

Step 2: PA Monitor + Texts with Meetings

Behavioral

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.

Step 3: PA Monitor

Behavioral

During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Primary outcomes

  1. Physical Activity-Steps

    Time frame: 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.

  2. Physical Activity- Moderate to Vigorous Physical Activity (MVPA)

    Time frame: 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 outcomes

  1. Cardiovascular Health (1)

    Time frame: 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.

  2. Cardiovascular Health (2)

    Time frame: 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

  3. Cardiovascular Health (3)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Michigan State University
  • National Institute of Nursing Research (NINR)
  • University of Illinois at Chicago

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Jun 15, 2018
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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