Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

NCT ID: NCT03558828

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 301 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2025-06-30

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.

Conditions

Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Step 1: PA Monitor

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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: 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).

Group Type: EXPERIMENTAL

Step 2: PA Monitor with Calls

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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: Maintenance

At Weeks 35-50 (maintenance phase) all participants in the study return to an enhanced physical activity monitor only treatment component.

Group Type: EXPERIMENTAL

Step 3: PA Monitor

Intervention Type: BEHAVIORAL

During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Step 3: PA Monitor

During Weeks 35-50, all women will receive enhanced physical activity monitors only.

Intervention Type: BEHAVIORAL

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")

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Buchholz, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University, College of Nursing

Locations

Rush University College of Nursing

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27251878 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27404642 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31899371 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36093873 (View on PubMed)

Buchholz 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.

Reference Type: BACKGROUND

PMID: 40328439 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01NR017635-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCT03558828

Identifier Type: REGISTRY

Identifier Source: secondary_id

DUNS: 068610245

Identifier Type: OTHER

Identifier Source: secondary_id

UEI: C155UU2TXCP3

Identifier Type: OTHER

Identifier Source: secondary_id

EIN: 1362174823A1

Identifier Type: OTHER

Identifier Source: secondary_id

17053108-IRB01

Identifier Type: -

Identifier Source: org_study_id