Physical ActivityNCT03558828
Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
A study testing Step 1: PA Monitor, Step 1: PA Monitor + Text and Step 2: PA Monitor with Calls in people with Physical Activity, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Step 1: PA Monitor, Step 1: PA Monitor + Text and Step 2: PA Monitor with Calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2018to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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")
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University College of Nursing
Chicago, Illinois, 60612
About this study
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.
Read the 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
- Being tested
- Step 1: PA Monitor, Step 1: PA Monitor + Text, Step 2: PA Monitor with Calls, Step 2: PA Monitor with Meetings, Step 2: PA Monitor + Texts with Calls
- 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
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1: PA MonitorBehavioural
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 + TextBehavioural
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 CallsBehavioural
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 MeetingsBehavioural
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 CallsBehavioural
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 MeetingsBehavioural
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 MonitorBehavioural
During Weeks 35-50, all women will receive enhanced physical activity monitors only.
| Study group | Role | What they receive |
|---|---|---|
| Step1: Initial Treatment | Experimental | 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. Receives: Behavioral: Step 1: PA Monitor; Behavioral: Step 1: PA Monitor + Text |
| Step 2: Augmented Treatment | Experimental | 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). Receives: 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 |
| Step 3: Maintenance | Experimental | At Weeks 35-50 (maintenance phase) all participants in the study return to an enhanced physical activity monitor only treatment component. Receives: Behavioral: Step 3: PA Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity-Steps
Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.
Measured: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.
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.
Measured: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.
Secondary outcomes (3)
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.
Measured: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.
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
Measured: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.
Cardiovascular Health (3)
Body composition: Average waist circumference was measured in inches.
Measured: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start24 Aug 2018
- Primary completion28 Aug 2023
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago, Michigan State University, National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Susan Buchholz, PhD, Principal investigator, Michigan State University, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558828
- Sponsor's protocol ID
- 17053108-IRB01
- Other IDs
- 5R01NR017635-04, NCT03558828, DUNS: 068610245, UEI: C155UU2TXCP3, EIN: 1362174823A1
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2018
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchholz SW, Ingram D, Wilbur J, Fogg L, Sandi G, Moss A, Ocampo EV. Bilingual Text4Walking Food Service Employee Intervention Pilot Study. JMIR Mhealth Uhealth. 2016 Jun 1;4(2):e68. doi: 10.2196/mhealth.5328.
PubMed 27251878Wilbur J, Miller AM, Fogg L, McDevitt J, Castro CM, Schoeny ME, Buchholz SW, Braun LT, Ingram DM, Volgman AS, Dancy BL. Randomized Clinical Trial of the Women's Lifestyle Physical Activity Program for African-American Women: 24- and 48-Week Outcomes. Am J Health Promot. 2016 May;30(5):335-45. doi: 10.1177/0890117116646342.
PubMed 27404642Buchholz SW, Wilbur J, Halloway S, Schoeny M, Johnson T, Vispute S, Kitsiou S. Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women. Contemp Clin Trials. 2020 Feb;89:105921. doi: 10.1016/j.cct.2019.105921. Epub 2019 Dec 30.
PubMed 31899371Daniel M, Buchholz SW, Schoeny M, Halloway S, Kitsiou S, Johnson T, Vispute S, Kapp M, Wilbur J. Effects of the COVID-19 pandemic on recruitment for the working women walking program. Res Nurs Health. 2022 Oct;45(5):559-568. doi: 10.1002/nur.22258. Epub 2022 Sep 12.
PubMed 36093873Buchholz SW, Daniel M, Kitsiou S, Schoeny ME, Halloway S, Johnson TJ, Vispute S, Wilbur J. Working Women Walking Program: A Sequential Multiple Assignment Randomized Trial. J Phys Act Health. 2025 May 6;22(7):778-792. doi: 10.1123/jpah.2024-0790. Print 2025 Jul 1.
PubMed 40328439Daniel M, Buchholz SW, Schoeny ME, Kitsiou S, Halloway S, Johnson T, Vispute S, Wilbur J. Moderators of adaptive interventions for physical activity outcomes in the Working Women Walking program: a sequential multiple assignment randomized trial design. Ann Behav Med. 2026 Jan 7;60(1):kaag010. doi: 10.1093/abm/kaag010.
PubMed 42847366
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
- ClinicalTrials.gov ID
- NCT03558828
- Acronym / sponsor ID
- 17053108-IRB01
- Conditions
- Physical Activity
- Keywords
- physical activity, women, sedentary, accelerometer, text message, group meeting, personal call, workplace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- University of Illinois Chicago, Michigan State University, National Institute of Nursing Research (NINR)
- Study start
- 24 Aug 2018 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
| Arm | Type | Receives |
|---|---|---|
| Step1: Initial Treatment | Experimental | Behavioral: Step 1: PA Monitor, Behavioral: Step 1: PA Monitor + TextParticipants 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. |
| Step 2: Augmented Treatment | Experimental | 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 MeetingsAt 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). |
| Step 3: Maintenance | Experimental | Behavioral: Step 3: PA MonitorAt Weeks 35-50 (maintenance phase) all participants in the study return to an enhanced physical activity monitor only treatment component. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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")
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1: PA MonitorThe 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. | Behavioural | Step1: Initial Treatment |
| Step 1: PA Monitor + TextThe 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. | Behavioural | Step1: Initial Treatment |
| Step 2: PA Monitor with CallsNonresponders 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. | Behavioural | Step 2: Augmented Treatment |
| Step 2: PA Monitor with MeetingsNonresponders 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. | Behavioural | Step 2: Augmented Treatment |
| Step 2: PA Monitor + Texts with CallsNonresponders 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. | Behavioural | Step 2: Augmented Treatment |
| Step 2: PA Monitor + Texts with MeetingsNonresponders 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. | Behavioural | Step 2: Augmented Treatment |
| Step 3: PA MonitorDuring Weeks 35-50, all women will receive enhanced physical activity monitors only. | Behavioural | Step 3: Maintenance |
Primary outcome
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.
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.
3 secondary outcomes
Cardiovascular Health (1)
Time frame: 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.
Cardiovascular Health (3)
Time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27251878Buchholz SW, Ingram D, Wilbur J, Fogg L, Sandi G, Moss A, Ocampo EV. Bilingual Text4Walking Food Service Employee Intervention Pilot Study. JMIR Mhealth Uhealth. 2016 Jun 1;4(2):e68. doi: 10.2196/mhealth.5328.
- Background: PubMed 27404642Wilbur J, Miller AM, Fogg L, McDevitt J, Castro CM, Schoeny ME, Buchholz SW, Braun LT, Ingram DM, Volgman AS, Dancy BL. Randomized Clinical Trial of the Women's Lifestyle Physical Activity Program for African-American Women: 24- and 48-Week Outcomes. Am J Health Promot. 2016 May;30(5):335-45. doi: 10.1177/0890117116646342.
- Background: PubMed 31899371Buchholz SW, Wilbur J, Halloway S, Schoeny M, Johnson T, Vispute S, Kitsiou S. Study protocol for a sequential multiple assignment randomized trial (SMART) to improve physical activity in employed women. Contemp Clin Trials. 2020 Feb;89:105921. doi: 10.1016/j.cct.2019.105921. Epub 2019 Dec 30.
- Background: PubMed 36093873Daniel M, Buchholz SW, Schoeny M, Halloway S, Kitsiou S, Johnson T, Vispute S, Kapp M, Wilbur J. Effects of the COVID-19 pandemic on recruitment for the working women walking program. Res Nurs Health. 2022 Oct;45(5):559-568. doi: 10.1002/nur.22258. Epub 2022 Sep 12.
- Background: PubMed 40328439Buchholz SW, Daniel M, Kitsiou S, Schoeny ME, Halloway S, Johnson TJ, Vispute S, Wilbur J. Working Women Walking Program: A Sequential Multiple Assignment Randomized Trial. J Phys Act Health. 2025 May 6;22(7):778-792. doi: 10.1123/jpah.2024-0790. Print 2025 Jul 1.
- Derived from this study: PubMed 42847366Daniel M, Buchholz SW, Schoeny ME, Kitsiou S, Halloway S, Johnson T, Vispute S, Wilbur J. Moderators of adaptive interventions for physical activity outcomes in the Working Women Walking program: a sequential multiple assignment randomized trial design. Ann Behav Med. 2026 Jan 7;60(1):kaag010. doi: 10.1093/abm/kaag010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Buchholz, PhD principal investigator
Michigan State University, College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step 1: PA Monitor, Step 1: PA Monitor + Text and Step 2: PA Monitor with Calls in people with Physical Activity, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity-Steps (time frame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03558828, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.