Cardiometabolic Risk FactorsRISE-WNCT07704749
Fitbit-Tracked Micromovement for Cardiometabolic Health in Rural Women
A study testing RISE-W Micro-Movement Program in people with Cardiometabolic Risk Factors, run by Texas Tech University Health Sciences Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- RISE-W Micro-Movement Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Texas Tech University Health Sciences Center Clinical Research Institute
Lubbock, Texas, 79430
CRI Research Assistant, 806-743-4222, clinicalresearch@ttuhsc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- RISE-W Micro-Movement Program
- Keywords
- micro-movement, cardiometabolic syndrome, rural, women
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RISE-W Micro-Movement ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: RISE-W Micro-Movement Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Over the 12-week intervention period
Secondary outcomes (9)
Change in waist circumference
Change in waist circumference measured in centimeters using a non-stretch tape per standardized protocol. A decrease indicates reduced cardiometabolic risk.
Measured: Baseline and 12 weeks
Change in blood pressure
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.
Measured: Baseline and 12 weeks
Change in fasting blood glucose
Change in fasting blood glucose (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Measured: Baseline and 12 weeks
Change in triglycerides
Change in triglycerides (mg/dL) from a fasting venous sample. A decrease indicates reduced cardiometabolic risk.
Measured: Baseline and 12 weeks
Change in HDL cholesterol
Change in high-density lipoprotein cholesterol (mg/dL) from a fasting venous sample. An increase indicates reduced cardiometabolic risk.
Measured: Baseline and 12 weeks
Change in C-reactive protein (CRP)
Change in serum C-reactive protein (mg/L). A decrease indicates reduced systemic inflammation.
Measured: Baseline and 12 weeks
Change in interleukin-6 (IL-6)
Change in serum interleukin-6 (pg/mL). A decrease indicates reduced systemic inflammation.
Measured: Baseline and 12 weeks
Change in body weight and BMI
Change in body weight (kg) and body mass index (kg/m²) from calibrated clinic measurements. A decrease indicates reduced cardiometabolic risk.
Measured: Baseline and 12 weeks
Change in self-reported physical activity
Change in self-reported physical activity (frequency and duration) via structured survey. An increase indicates improved activity.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeni Page, PhD, APRN, ACNP-BC, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704749
- Sponsor's protocol ID
- IRB-FY2026-236
- Other IDs
- IRB-FY2026-236
- Acronym
- RISE-W
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40814152Scott 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.
PubMed 31372797Ridker 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.
PubMed 32221587National 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.
PubMed 12485966Ferguson 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.
PubMed 35868813Fahed 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.
PubMed 35054972Chan 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.
PubMed 35121356Bell 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.
PubMed 29403314Batsis 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.
PubMed 31890242Alexe 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.
PubMed 41464286
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rural Initiative for Inflammatory Screening & Engagement for Women
- ClinicalTrials.gov ID
- NCT07704749
- Acronym / sponsor ID
- RISE-W / IRB-FY2026-236
- Conditions
- Cardiometabolic Risk Factors
- Keywords
- micro-movement, cardiometabolic syndrome, rural, women
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Texas Tech University Health Sciences CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| RISE-W Intervention | Experimental | Behavioral: RISE-W Micro-Movement ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RISE-W Micro-Movement ProgramBrief, 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. | Behavioural | RISE-W Intervention |
Primary outcome
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.
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.
9 secondary outcomes
Change in waist circumference
Time frame: Baseline and 12 weeks
Change in blood pressure
Time frame: Baseline and 12 weeks
Change in fasting blood glucose
Time frame: Baseline and 12 weeks
Change in triglycerides
Time frame: Baseline and 12 weeks
Change in HDL cholesterol
Time frame: Baseline and 12 weeks
Change in C-reactive protein (CRP)
Time frame: Baseline and 12 weeks
Change in interleukin-6 (IL-6)
Time frame: Baseline and 12 weeks
Change in body weight and BMI
Time frame: Baseline and 12 weeks
Change in self-reported physical activity
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 40814152Wan 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.
- Background: PubMed 31372797Scott 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.
- Background: PubMed 32221587Ridker 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.
- Background: PubMed 12485966National 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.
- Background: PubMed 35868813Ferguson 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.
- Background: PubMed 35054972Fahed 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.
- Background: PubMed 35121356Chan 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.
- Background: PubMed 29403314Bell 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.
- Background: PubMed 31890242Batsis 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.
- Background: PubMed 41464286Alexe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Texas Tech University Health Sciences Center Clinical Research Institute
Lubbock, United States
Jeni Page, PhD, APRN, ACNP-BC principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RISE-W Micro-Movement Program in people with Cardiometabolic Risk Factors, run by Texas Tech University Health Sciences Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study completion rate (feasibility) (time frame: Baseline through 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07704749, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.