Testing Adaptive Interventions to Improve Physical Activity for Sedentary Women

NCT03558828 | Completed Results DMC

• 6 other identifiers: 17053108-IRB015R01NR017635-04NCT03558828DUNS: 068610245UEI: C155UU2TXCP3EIN: 1362174823A1
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Physical Activity-Steps

  Physical activity-Steps: Average daily steps were measured with ActiGraph worn on the right hip during waking hours for one week.

  Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for steps.

• Physical Activity- Moderate to Vigorous Physical Activity (MVPA)

  Average daily minutes of Moderate to Vigorous Physical Activity (MVPA) were measured with ActiGraph worn on the right hip during waking hours for one week.

  Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for MVPA.

Secondary Outcomes (3)

• Cardiovascular Health (1)

  Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for aerobic fitness.

• Cardiovascular Health (2)

  Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for BMI.

• Cardiovascular Health (3)

  Baseline plus change is being assessed after 8 weeks, 34 weeks, and 50 weeks for waist measurement.

Study Arms (3)

Step1: Initial Treatment

EXPERIMENTAL

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; Behavioral: Step 1: PA Monitor + Text

Step 2: Augmented Treatment

EXPERIMENTAL

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; Behavioral: Step 2: PA Monitor with Meetings; Behavioral: Step 2: PA Monitor + Texts with Calls; Behavioral: Step 2: PA Monitor + Texts with Meetings

Step 3: Maintenance

EXPERIMENTAL

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

Interventions

Step 1: PA Monitor 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.

Step1: Initial Treatment

Step 1: PA Monitor + Text 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.

Step1: Initial Treatment

Step 2: PA Monitor with Calls 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: Augmented Treatment

Step 2: PA Monitor with Meetings 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: Augmented Treatment

Step 2: PA Monitor + Texts with Calls 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: Augmented Treatment

Step 2: PA Monitor + Texts with Meetings 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 2: Augmented Treatment

Step 3: PA Monitor BEHAVIORAL

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

Step 3: Maintenance

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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")

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Illinois at Chicago: collaborator
• Michigan State University: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Rush University College of Nursing

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 27251878 BACKGROUND

• 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.

  PMID: 27404642 BACKGROUND

• 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.

  PMID: 31899371 BACKGROUND

• 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.

  PMID: 36093873 BACKGROUND

• 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.

  PMID: 40328439 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Manju Daniel
• Organization: Rush University College of Nursing

manju_n_daniel@rush.edu

312.942.3460

Study Officials

• Susan Buchholz, PhD

  Michigan State University, College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Sequential Multiple Assignment Randomized Trial (SMART) design is used for this study.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: June 15, 2018
• Study Start: August 24, 2018
• Primary Completion: August 28, 2023
• Study Completion: June 30, 2025
• Last Updated: August 3, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)