Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

July 23, 2025 updated by: Rush University Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
301

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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")

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Step1: Initial Treatment
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
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.
Experimental: Step 2: Augmented Treatment

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

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.
Experimental: Step 3: Maintenance
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
During Weeks 35-50, all women will receive enhanced physical activity monitors only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.
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.
Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.
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
Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.
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.
Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
University of Illinois at Chicago
Michigan State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Buchholz, PhD, Michigan State University, College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 24, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17053108-IRB01
  • DUNS: 068610245 (Other Identifier: Rush University Medical Center)
  • 5R01NR017635-04 (U.S. NIH Grant/Contract)
  • NCT03558828 (Registry Identifier: clinicaltrials.gov)
  • UEI: C155UU2TXCP3 (Other Identifier: Rush University Medical Center)
  • EIN: 1362174823A1 (Other Identifier: Rush University Medical Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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