- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558828
Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University College of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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). |
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. 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. 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. 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.
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During Weeks 35-50, all women will receive enhanced physical activity monitors only.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity-Steps
Time Frame: Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Daily steps measured with ActiGraph
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Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Physical activity-MVPA
Time Frame: Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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In our original protocol, MVPA outcome was minutes of moderate-to-vigorous physical activity/week measured with ActiGraph; however, given our concerns that days with <10 hours of wear time may be systematically different than those with >10 hours of wear time, MVPA is being reported on average minutes per valid day.
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Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiovascular health (1)
Time Frame: Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Aerobic fitness: participants step in place to a predesignated height for 2 minutes
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Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Cardiovascular health (2)
Time Frame: Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Body composition: BMI (weight measured in pounds; height measured in inches)
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Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Cardiovascular health (3)
Time Frame: Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Body composition: waist measured in inches
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Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan Buchholz, PhD, Michigan State University, College of Nursing
Publications and helpful links
General 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.
- Wilbur 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.
- Buchholz 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.
- Daniel 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17053108-IRB01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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