Fitbit-Tracked Micromovement for Cardiometabolic Risk Factors

(RISE-W Trial)

Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Texas Tech University Health Sciences Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot study tests whether a low-burden prevention program can be integrated into routine care to identify and reduce cardiometabolic risk in rural women. Rural women face high rates of cardiometabolic syndrome, a cluster of conditions (elevated blood pressure, abdominal obesity, abnormal cholesterol, and high blood sugar) that raises the risk of heart disease and diabetes, yet often face barriers to prevention and screening.

The study enrolls physically inactive adult women with multiple cardiometabolic risk factors who receive care at a rural federally qualified health center. At a baseline visit, participants complete surveys and clinical assessments including inflammatory biomarkers (C-reactive protein and interleukin-6), metabolic labs, blood pressure, waist circumference, menopausal status, and social determinants of health. Participants then take part in a 12-week program of brief, frequent daily movement supported by a wearable activity tracker. Assessments are repeated at 12 weeks.

Because this is a single-group pilot, every participant receives the program and serves as her own comparison. The study evaluates whether the model is feasible to run within routine clinic workflows and examines preliminary changes in cardiometabolic and inflammatory risk indicators. Findings will inform larger studies of scalable prevention strategies for rural women.

Who Is on the Research Team?

JP

Jeni Page, PhD, APRN, ACNP-BC

Principal Investigator

Texas Tech University Health Sciences Center

Are You a Good Fit for This Trial?

This trial is for adult women living in rural areas who are physically inactive and have several risk factors for heart disease or diabetes, such as high blood pressure, large waist size, abnormal cholesterol, or high blood sugar. Participants must receive care at a rural health center.

Inclusion Criteria

Receiving care at one of the three Larry Combest Community Health & Wellness Center sites
Access to a personal or household smartphone (Apple iOS 16.4 or higher, or Android OS 11.0 or higher) capable of installing the Fitbit application; no cellular data plan required
Physically inactive, defined as less than 150 minutes of moderate-intensity physical activity per week by self-report
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Exclusion Criteria

No access to a smartphone or a smartphone unable to run the Fitbit application due to operating system incompatibility
Current pregnancy or planning to become pregnant during the study period
Medical conditions that preclude safe participation in light-to-moderate physical activity as determined by the PI through EHR review, including unstable cardiovascular disease, uncontrolled hypertension, severe musculoskeletal limitations
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What Are the Treatments Tested in This Trial?

Interventions

  • RISE-W Micro-Movement Program

Trial Overview

The study tests a 12-week program where participants use a wearable activity tracker (like a Fitbit) to encourage brief daily movement. All participants get the same program and their health markers are checked before and after the program.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RISE-W InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials
107
Recruited
11,500+