Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women

NCT07704749 | Not Yet Recruiting

• 1 other identifier: IRB-FY2026-236
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Risk Factors

Keywords

micro-movement; cardiometabolic syndrome; rural; women

Outcome Measures

Primary Outcomes (2)

• Study completion rate (feasibility)

  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)

  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 Outcomes (9)

• Change in waist circumference

  Baseline and 12 weeks

• Change in blood pressure

  Baseline and 12 weeks

• Change in fasting blood glucose

  Baseline and 12 weeks

• Change in triglycerides

  Baseline and 12 weeks

• Change in HDL cholesterol

  Baseline and 12 weeks

Study Arms (1)

RISE-W Intervention

EXPERIMENTAL

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

Interventions

RISE-W Micro-Movement Program BEHAVIORAL

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.

RISE-W Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center Clinical Research Institute

Lubbock, Texas, 79430, United States

Location

Related Publications (10)

• Wan KW, Dai ZH, Wong PS, Huang WY, Lei EF, Little JP, Lin FC, Tam BT. Effects of Exercise Snacks on Cardiometabolic Health and Body Composition in Adults: A Systematic Review and Meta-Analysis. Scand J Med Sci Sports. 2025 Aug;35(8):e70114. doi: 10.1111/sms.70114.

  PMID: 40814152 BACKGROUND

• Scott J, Dardas L, Sloane R, Wigington T, Noonan D, Simmons LA. Understanding Social Determinants of Cardiometabolic Disease Risk in Rural Women. J Community Health. 2020 Feb;45(1):1-9. doi: 10.1007/s10900-019-00710-0.

  PMID: 31372797 BACKGROUND

• Ridker PM, MacFadyen JG, Glynn RJ, Bradwin G, Hasan AA, Rifai N. Comparison of interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol as biomarkers of residual risk in contemporary practice: secondary analyses from the Cardiovascular Inflammation Reduction Trial. Eur Heart J. 2020 Aug 14;41(31):2952-2961. doi: 10.1093/eurheartj/ehaa160.

  PMID: 32221587 BACKGROUND

• National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.

  PMID: 12485966 BACKGROUND

• Ferguson T, Olds T, Curtis R, Blake H, Crozier AJ, Dankiw K, Dumuid D, Kasai D, O'Connor E, Virgara R, Maher C. Effectiveness of wearable activity trackers to increase physical activity and improve health: a systematic review of systematic reviews and meta-analyses. Lancet Digit Health. 2022 Aug;4(8):e615-e626. doi: 10.1016/S2589-7500(22)00111-X.

  PMID: 35868813 BACKGROUND

• Fahed G, Aoun L, Bou Zerdan M, Allam S, Bou Zerdan M, Bouferraa Y, Assi HI. Metabolic Syndrome: Updates on Pathophysiology and Management in 2021. Int J Mol Sci. 2022 Jan 12;23(2):786. doi: 10.3390/ijms23020786.

  PMID: 35054972 BACKGROUND

• Chan A, Chan D, Lee H, Ng CC, Yeo AHL. Reporting adherence, validity and physical activity measures of wearable activity trackers in medical research: A systematic review. Int J Med Inform. 2022 Apr;160:104696. doi: 10.1016/j.ijmedinf.2022.104696. Epub 2022 Jan 31.

  PMID: 35121356 BACKGROUND

• Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.

  PMID: 29403314 BACKGROUND

• Batsis JA, McClure AC, Weintraub AB, Kotz DF, Rotenberg S, Cook SB, Gilbert-Diamond D, Curtis K, Stevens CJ, Sette D, Rothstein RI. Feasibility and acceptability of a rural, pragmatic, telemedicine-delivered healthy lifestyle programme. Obes Sci Pract. 2019 Oct 17;5(6):521-530. doi: 10.1002/osp4.366. eCollection 2019 Dec.

  PMID: 31890242 BACKGROUND

• Alexe DI, Saha S, Choudhary PK, Alexe CI, Choudhary S, Tohanean DI. Exercise Snacks as a Strategy to Interrupt Sedentary Behavior: A Systematic Review of Health Outcomes and Feasibility. Healthcare (Basel). 2025 Dec 9;13(24):3216. doi: 10.3390/healthcare13243216.

  PMID: 41464286 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeni Page, PhD, APRN, ACNP-BC

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)