Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Physical Activity Clinical Trial

Official title:

Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03558828
• Other study ID #: 17053108-IRB01
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and improve cardiovascular health among sedentary employed women.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 301
• Est. completion date: September 30, 2024
• Est. primary completion date: August 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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")

Related Conditions & MeSH terms

• Physical Activity

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Step 3: PA Monitor
During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Locations

Country	Name	City	State
United States	Rush University College of Nursing	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Rush University Medical Center	Michigan State University, University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity-Steps	Daily steps measured with ActiGraph	Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
Primary	Physical activity-MVPA	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.	Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
Secondary	Cardiovascular health (1)	Aerobic fitness: participants step in place to a predesignated height for 2 minutes	Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
Secondary	Cardiovascular health (2)	Body composition: BMI (weight measured in pounds; height measured in inches)	Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52
Secondary	Cardiovascular health (3)	Body composition: waist measured in inches	Baseline plus change is being assessed at weeks 9-10, 35-36, and 51-52