Adaptive Physical Activity Interventions for Low Physical Activity

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Pulmonary disease, Cardiovascular disease, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 95

301 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Adaptive Physical Activity Interventions for Low Physical Activity?

Research shows that using activity monitors and providing feedback can increase physical activity levels, as seen in patients with chronic obstructive pulmonary disease (COPD). These interventions, which include feedback and self-monitoring, have been found to improve daily steps and standing time, suggesting that similar strategies could be effective in increasing physical activity in other populations. ^{1 2 3 4 5}

Is using physical activity monitors safe for humans?

The studies reviewed do not report any safety concerns related to using physical activity monitors, suggesting they are generally safe for humans. ^{3 6 7 8 9}

What makes the Adaptive Physical Activity Interventions treatment unique for low physical activity?

This treatment is unique because it adapts to each person's progress, changing components like monitoring, texts, calls, and meetings based on how well someone is doing. This dynamic approach is different from traditional methods that use the same plan for everyone, making it more personalized and potentially more effective. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Susan Buchholz, PhD

Principal Investigator

Michigan State University, College of Nursing

Eligibility Criteria

This trial is for sedentary women aged 18-70 who work at the study site, own a smartphone, can speak/read English, and are able to walk. Women with certain types of diabetes may join if cleared by their doctor. It's not for those with high blood pressure, heart/lung disease symptoms or who already take enough steps daily.

Inclusion Criteria

Able to speak/read English

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

I am willing to receive text messages as required.

Exclusion Criteria

I have significant symptoms related to lung or heart disease.

Sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat active")

Systolic BP ≥ 160 and/or diastolic BP ≥ 100

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomly assigned to an enhanced physical activity monitor or enhanced physical activity monitor with motivational text messaging for 8 weeks

8 weeks

Baseline visit

Augmented Treatment

Non-responders to initial treatment receive additional personal calls or group meetings from weeks 9-34

26 weeks

Assessment at weeks 9-10

Maintenance

All participants return to an enhanced physical activity monitor only treatment component from weeks 35-50

16 weeks

Assessment at weeks 35-36

Follow-up

Participants are monitored for physical activity and cardiovascular health outcomes

2 weeks

Final assessment at weeks 51-52

Treatment Details

Interventions

• Step 1: PA Monitor
• Step 1: PA Monitor + Text
• Step 2: PA Monitor + Texts with Calls
• Step 2: PA Monitor + Texts with Meetings
• Step 2: PA Monitor with Calls
• Step 2: PA Monitor with Meetings
• Step 3: PA Monitor

Trial Overview The study tests which combination of four treatments (activity monitor enhancements, motivational texts/calls, group meetings) works best to increase physical activity and improve heart health in inactive working women using a SMART design.

Participant Groups

Group I: Step1: Initial Treatment Experimental Treatment 2 Interventions

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 II: Step 3: Maintenance Experimental Treatment 1 Intervention

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

Group III: Step 2: Augmented Treatment Experimental Treatment 4 Interventions

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).

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Findings from Research

A novel Internet-mediated, pedometer-based exercise intervention for veterans with COPD led to significant improvements in health-related quality of life (HRQL) domains, particularly in Symptoms and Impact, after 4 months.

Participants in the intervention group increased their daily step counts by an average of 779 steps compared to the control group, indicating that the program effectively encouraged physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. Moy, ML., Collins, RJ., Martinez, CH., et al.[2022]

Interventions using activity trackers during and after inpatient care can significantly increase physical activity levels in patients, with a small positive effect size (SMD = 0.34) observed in 13 studies involving 1435 patients.

However, these increases in physical activity did not lead to significant improvements in physical functioning, indicating that while activity trackers can motivate patients to move more, they may not directly enhance overall physical capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. de Leeuwerk, ME., Bor, P., van der Ploeg, HP., et al.[2022]

A review of 22 studies on electronic activity monitor systems (EAMSs) showed that they can effectively enhance physical activity and weight loss in nonclinical populations, particularly when used for 6 weeks to 12 months.

Interventions that included multiple features of EAMSs, along with additional support like personal coaching, led to better health outcomes, but simply adding EAMSs to existing programs without unique components did not significantly improve results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Use of an Electronic Activity Monitor System as a Component of Physical Activity and Weight-Loss Interventions in Nonclinical Populations: A Systematic Review. Sypes, EE., Newton, G., Lewis, ZH.[2020]

An adaptive intervention for physical activity, which adjusted daily step goals based on individual performance, led to a significant increase in steps per day (2,728 steps) compared to a static intervention (1,598 steps) over a 6-month period with 20 participants.

The study demonstrated that the adaptive approach was more effective in promoting physical activity, suggesting that such dynamic goal-setting methods could be integrated into mobile health technologies to benefit larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptive physical activity intervention for overweight adults: a randomized controlled trial. Adams, MA., Sallis, JF., Norman, GJ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

An Internet-Mediated Pedometer-Based Program Improves Health-Related Quality-of-Life Domains and Daily Step Counts in COPD: A Randomized Controlled Trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance prOgram following PUlmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Impact of feedback on physical activity levels of individuals with chronic obstructive pulmonary disease during pulmonary rehabilitation: A feasibility study. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Interventions to Increase Physical Activity in Patients with COPD: A Comprehensive Review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of physical activity interventions using activity trackers during or after inpatient care: a systematic review and meta-analysis of randomized controlled trials. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Investigating the Use of an Electronic Activity Monitor System as a Component of Physical Activity and Weight-Loss Interventions in Nonclinical Populations: A Systematic Review. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Technical Assistance Received by Older Adults to Use Commercially Available Physical Activity Monitors (Ready Steady 3.0 Trial): Ad-Hoc Descriptive Longitudinal Study. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

The influence of wearing schemes and supportive telephone calls on adherence in accelerometry measurement: results of a randomized controlled trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The Physical Activity Vital Sign: a primary care tool to guide counseling for obesity. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

An adaptive physical activity intervention for overweight adults: a randomized controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Self-monitoring moderate-vigorous physical activity versus steps/day is more effective in chronic disease exercise programs. [2022]

12. Ireland pubmed.ncbi.nlm.nih.gov

Australian patients' perception of the efficacy of the physical activity referral scheme (PARS). [2022]

13. England pubmed.ncbi.nlm.nih.gov

Effect of a 1-year intervention comprising brief counselling sessions and low-dose physical activity recommendations in Japanese adults, and retention of the effect at 2 years: a randomized trial. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Convergent validity of 3 low cost motion sensors with the ActiGraph accelerometer. [2019]