Clinical trial NCT03558828: Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
Official title: Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Physical Activity
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
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Illinois at Chicago
name: Michigan State University
name: National Institute of Nursing Research (NINR)
First posted: 2018-06-15
Enrollment: 301
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.
Primary purpose: PREVENTION

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.

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.

Eligibility 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
* 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")

Primary outcomes:
measure: Physical Activity-Steps
timeFrame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.
measure: Physical Activity- Moderate to Vigorous Physical Activity (MVPA)
timeFrame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.
Secondary outcomes:
measure: Cardiovascular Health (1)
timeFrame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.
measure: Cardiovascular Health (2)
timeFrame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.
measure: Cardiovascular Health (3)
timeFrame: Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University College of Nursing
state: Illinois
Study officials:
affiliation: Michigan State University, College of Nursing
name: Susan Buchholz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.