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Trial record 7 of 3071 for:    Recruiting, Not yet recruiting, Available Studies | Physical

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

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ClinicalTrials.gov Identifier: NCT03558828
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Rush University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Step 1: PA Monitor Behavioral: Step 1: PA Monitor + Text 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 Behavioral: Step 3: PA Monitor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Physical activity [ Time Frame: Baseline to 50 weeks ]
    Step counts per day



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Insufficiently active (based on self-report, does not meet recommended moderate- or vigorous-intensity physical activity guidelines [moderate-intensity physical activity, <150 minutes/week; vigorous-intensity physical activity, < 75 minutes/week] or inactive [no leisure time physical activity in the past month or no moderate or high intensity physical activity for 10 or more minutes])
  • 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")

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03558828


Contacts
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Contact: Susan Buchholz, PhD 3125633590 susan_buchholz@rush.edu
Contact: Peter Cummings, MPH 3129425861 Peter_Cummings@rush.edu

Locations
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United States, Illinois
Rush University College of Nursing Recruiting
Chicago, Illinois, United States, 60612
Contact: Susan W Buchholz, PhD    312-563-3590    susan_buchholz@rush.edu   
Contact: JoEllen Wilbur, PhD    3129428947    Joellen_Wilbur@rush.edu   
Sponsors and Collaborators
Rush University Medical Center
University of Illinois at Chicago
Investigators
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Principal Investigator: Susan Buchholz, PhD Rush University Medical Center, College of Nursing
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Statistical Analysis Plan  [PDF] March 21, 2018
Study Protocol  [PDF] October 4, 2018
Informed Consent Form  [PDF] September 4, 2018


Publications:
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03558828     History of Changes
Other Study ID Numbers: 17053108-IRB01
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
physical activity
women
sedentary
accelerometer
text message
group meeting
personal call
workplace
cost-effectiveness
Sequential Multiple Assignment Randomized Trial
adaptive intervention
Actigraph
Fitbit
iCardia