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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to discover the most effective ways to motivate sedentary women to become active and enhance heart health. It tests various combinations of tools, such as fitness trackers (called PA Monitors), motivational texts, personal calls, and group meetings, to determine the most effective approach. Women who work at the study site, speak English, own a smartphone, and do not already walk frequently may be suitable candidates. This study is particularly relevant for those managing diabetes with their doctor's approval.

As an unphased trial, it offers participants the opportunity to contribute to innovative strategies for improving heart health and motivation.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that wearable fitness trackers are safe and effective in encouraging increased physical activity. Studies consistently find that these devices help boost moderate to vigorous exercise levels without major safety concerns.

Motivational text messages sent with trackers also yield positive results. These texts can enhance motivation and remind individuals to stay active, with no significant safety issues reported.

Researchers have explored adding personal calls or group meetings for extra support and motivation. While specific safety data on these combinations is limited, the individual components, such as trackers and texts, are well-tolerated.

In summary, these strategies—whether used alone or together—are generally safe. They aim to promote healthier habits without posing significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these adaptive physical activity interventions because they offer a personalized approach to boosting activity levels. Unlike standard options that might include general fitness advice or fixed exercise programs, these treatments dynamically adjust based on individual progress. For instance, participants might start with just a physical activity monitor and later receive motivational texts, personal calls, or group meetings if they need extra support. This tailored method aims to keep people engaged and motivated, potentially leading to better long-term results in increasing physical activity.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in sedentary employed women?

This trial will evaluate different adaptive physical activity interventions for individuals with low physical activity. Research has shown that fitness trackers can help people move more and sit less. Participants will initially receive either an enhanced physical activity monitor or an enhanced monitor with motivational text messaging. Studies have found that motivational text messages with these trackers can increase activity levels. For those who do not meet their physical activity goals, additional interventions such as personal phone calls or group meetings will be tested. When personal phone calls are added, participants often become more active. Group meetings can also enhance these efforts, leading to better overall health. Together, these methods seem promising for encouraging movement and improving heart health, especially for those who are usually inactive. ^{1 3 6 7 8}

Who Is on the Research Team?

Susan Buchholz, PhD

Principal Investigator

Michigan State University, College of Nursing

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8791066/

Effectiveness of physical activity monitors in adults: systematic ...

Main outcome measures. The three primary outcomes of interest were physical activity, moderate to vigorous physical activity, and sedentary time ...

2.

bmj.com

bmj.com/content/376/bmj-2021-068047

Effectiveness of physical activity monitors in adults

PAM based interventions are safe and effectively increase physical activity and moderate to vigorous physical activity.

3.

jospt.org

jospt.org/doi/10.2519/jospt.2022.10874

Adding Physical Activity Coaching and an Activity Monitor ...

Adding targeted physical activity coaching and an activity monitor did not reduce pain intensity or disability more than an attention control approach.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12285027/

Effectiveness of different intervention designs for improving ...

All four physical activity interventions significantly improved daily step count by 1576 to 3287 over the brief 16-week duration compared with ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2451865425000900

The use of consumer-grade physical activity monitors

Of the participants, 40% reported using a PA monitor in the past month. Demographics and psychosocial determinants of PA explained 12% of PA ...

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2782127

Interventions Using Wearable Physical Activity Trackers ...

The findings suggest that use of wearable PA trackers (especially pedometers) is associated with increased PA levels among people with cardiometabolic ...

7.

eurapa.biomedcentral.com

eurapa.biomedcentral.com/articles/10.1186/s11556-023-00320-9

Physical activity monitoring-based interventions in geriatric ...

To identify and analyze the components applied in interventions using physical activity (PA) monitoring in geriatric patients and determine their feasibility ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12271070/

The use of consumer-grade physical activity monitors

Consumer-grade physical activity (PA) monitors are used to optimize enrollment in clinical trials, to evaluate PA behavior, or to promote PA.