Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women (RISE-W)

July 10, 2026 updated by: Texas Tech University Health Sciences Center

Rural Initiative for Inflammatory Screening & Engagement for Women

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Thought process Thought process Here are both, written to PRS conventions and ready to paste. Brief Summary is lay-facing and concise; Detailed Description carries the technical detail.

Brief Summary 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.

Detailed Description Background. Cardiometabolic syndrome (CMS) substantially increases the risk of cardiovascular disease, type 2 diabetes, and early mortality. Rural women experience disproportionately high rates of CMS due to structural and social barriers, and risk is often identified only after disease has progressed. Systemic inflammation contributes to CMS development, and biomarkers such as C-reactive protein (CRP) and interleukin-6 (IL-6) can rise before metabolic abnormalities appear, offering an opportunity for earlier risk identification. Physical inactivity and prolonged sedentary time contribute to metabolic dysregulation; brief, frequent bouts of movement supported by wearable trackers may help interrupt sedentary behavior.

Purpose. This pilot evaluates the feasibility of the Rural Initiative for Inflammatory Screening and Engagement for Women (RISE-W), a pragmatic prevention model designed to support early identification and reduction of cardiometabolic risk among physically inactive rural women receiving care at a federally qualified health center.

Design. Prospective, single-group, pre-post pilot interventional design. All enrolled participants receive the RISE-W intervention and serve as their own control, with outcomes assessed at baseline and at the conclusion of the 12-week intervention.

Objectives.

Evaluate the feasibility of integrating inflammatory biomarkers, metabolic screening, and cardiometabolic risk assessment into routine care.

Implement and assess the acceptability of and adherence to a low-burden prevention strategy incorporating micro-movement physical activity.

Examine preliminary changes in cardiometabolic risk indicators (inflammatory biomarkers, metabolic markers, blood pressure, and waist circumference) over 12 weeks.

Assess the feasibility of embedding the model within existing clinic workflows without increasing clinician workload.

Intervention. A 12-week pragmatic prevention strategy consisting of micro-movement physical activity: brief bouts of light-to-moderate movement each hour during waking hours (target of at least 10 hours per day), supported by a wearable activity tracker (Fitbit Inspire 3) providing automated hourly movement reminders and self-monitoring.

Assessments. At baseline, participants complete demographic and health questionnaires, a social determinants of health questionnaire, and menopausal staging, along with anthropometric measurements (waist circumference, height, weight), blood pressure, and fasting blood samples for metabolic indicators (fasting glucose, triglycerides, HDL) and inflammatory biomarkers (CRP, IL-6). Post-intervention assessments at 12 weeks (study day 84 ± 14 days) repeat anthropometric measures, blood pressure, and biomarker collection, and include a self-report follow-up survey and download of the full activity-tracker dataset.

Outcomes. Primary outcomes are change from baseline to 12 weeks in cardiometabolic risk indicators (waist circumference, systolic and diastolic blood pressure, fasting glucose, triglycerides, HDL) and inflammatory biomarkers (CRP, IL-6), together with feasibility and adherence metrics (assessment completion and adherence to micro-movement activity). Secondary outcomes include anthropometric change (weight, BMI), self-reported physical activity, and exploratory associations of menopausal status and social determinants of health with adherence and outcomes.

Sample size. A target of 125 participants was selected to evaluate feasibility metrics and provide preliminary estimates of effect size and variability to inform future larger trials; the study is not powered for formal hypothesis testing.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center Clinical Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Female, aged 18 to 80 years Physically inactive, defined as less than 150 minutes of moderate-intensity physical activity per week (by self-report) Metabolic syndrome, defined as three or more cardiometabolic risk factors consistent with NCEP ATP III criteria, based on documented diagnosis or clinical history: waist circumference >88 cm; blood pressure ≥130/85 mmHg; fasting blood glucose ≥100 mg/dL; triglycerides ≥150 mg/dL; HDL cholesterol <50 mg/dL 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 Working email address Able to understand and provide written informed consent in English or Spanish Receiving care at one of the three Larry Combest Community Health & Wellness Center sites

Exclusion Criteria:

Current pregnancy or planning to become pregnant during the study period Medical conditions that preclude safe participation in light-to-moderate physical activity (e.g., unstable cardiovascular disease, uncontrolled hypertension, severe musculoskeletal limitations), as determined by the PI through EHR review Participation in another structured lifestyle or cardiometabolic intervention study within the past 6 months (self-report) Use of medications or treatments that significantly alter inflammation or metabolism (e.g., systemic corticosteroids, recent chemotherapy), as determined by the PI through EHR review Inability to comply with study procedures, including wearing the activity tracker or completing follow-up assessments No access to a smartphone, or a smartphone unable to run the Fitbit application due to operating system incompatibility

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RISE-W Intervention
Participants receive the 12-week RISE-W micro-movement prevention program: brief bouts of light-to-moderate movement each waking hour (target ≥10 hours/day), supported by a wearable activity tracker that provides hourly movement reminders and enables self-monitoring.
Behavioral: RISE-W Micro-Movement Program
Brief, frequent bouts of light-to-moderate movement performed each waking hour (target ≥10 hours/day) over 12 weeks, supported by a Fitbit Inspire 3 activity tracker that delivers automated hourly movement reminders and enables self-monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study completion rate (feasibility)
Time Frame: Baseline through 12 weeks
Proportion of enrolled participants who complete both baseline and 12-week follow-up assessments. Reported as a percentage; higher indicates greater feasibility.
Baseline through 12 weeks
Adherence to micro-movement intervention (feasibility)
Time Frame: Over the 12-week intervention period
Adherence measured by the wearable activity tracker as the percentage of hourly movement goals met across the intervention period. Reported as a percentage; higher indicates greater adherence.
Over the 12-week intervention period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: Baseline and 12 weeks
Change in waist circumference measured in centimeters using a non-stretch tape per standardized protocol. A decrease indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in blood pressure
Time Frame: Baseline and 12 weeks
Change in systolic and diastolic blood pressure (mmHg), measured after 5-minute seated rest as the average of two readings. A decrease indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in fasting blood glucose
Time Frame: Baseline and 12 weeks
Change in fasting blood glucose (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in triglycerides
Time Frame: Baseline and 12 weeks
Change in triglycerides (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in HDL cholesterol
Time Frame: Baseline and 12 weeks
Change in high-density lipoprotein cholesterol (mg/dL) from a fasting venous sample. An increase indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in C-reactive protein (CRP)
Time Frame: Baseline and 12 weeks
Change in serum C-reactive protein (mg/L). A decrease indicates reduced systemic inflammation.
Baseline and 12 weeks
Change in interleukin-6 (IL-6)
Time Frame: Baseline and 12 weeks
Change in serum interleukin-6 (pg/mL). A decrease indicates reduced systemic inflammation.
Baseline and 12 weeks
Change in body weight and BMI
Time Frame: Baseline and 12 weeks
Change in body weight (kg) and body mass index (kg/m²) from calibrated clinic measurements. A decrease indicates reduced cardiometabolic risk.
Baseline and 12 weeks
Change in self-reported physical activity
Time Frame: Baseline and 12 weeks
Change in self-reported physical activity (frequency and duration) via structured survey. An increase indicates improved activity.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Investigators

  • Principal Investigator: Jeni Page, PhD, APRN, ACNP-BC, Texas Tech University Health Sciences Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 15, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-FY2026-236 (Other Identifier: Texas Tech University Health Sciences Center Institute of Telehealth and Digital Innovation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiometabolic Risk Factors

Clinical Trials on RISE-W Micro-Movement Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe