Healthy AdultDRIVENCT07872995
Data-driven Rural Interventions for Vitality and Endurance Pilot Study
A study testing Data-driven lifestyle coaching in people with Healthy Adult, run by McLaughlin Research Institute for Biomedical Sciences, Inc. at 1 site in United States.
Trial summary
The study aims to explore whether data driven, personalized wellness interventions-based on integrated genomic, clinical, behavioral, and functional data- are feasible in a rural facing setting and can produce measurable improvements in cardiometabolic, cognitive, mental health, and functional wellness outcomes within… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- Data-driven lifestyle coaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >18 years of age or older at enrollment ● Weight is greater than or equal to 110 lbs
- Able and willing to comprehend and sign the informed consent document
- Able and willing to perform required physical performance tests
- Able and willing to provide study samples
- Able and willing to participate in study procedures
- Able and willing to complete surveys, cognitive assessments, and questionnaires in English only
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- Able and willing to wear a fitness tracker as continuously as possible for the duration of the study.
- Weissman Hood Institute at Touro University Protocol # MRI010 Data-driven Rural Interventions for Vitality and Endurance (DRIVE) Pilot page 5 of 36
- ● Has or has ready access to a PC, tablet, or smartphone with an internet connection required for procedures that they consent to
Who cannot join
- A diagnosis of dementia
- Self-reported pregnancy or breastfeeding
- Individuals not fluent in written and spoken English
- Self-reported chronic or end-stage disease that would interfere with their participation in the study
- Severe and non-correctable hearing and visual impairment that would interfere with the ability to complete study measures
- Individuals for whom the total volume of blood would exceed 550 mL over an 8-week period and/or more than two draws within one week for combined clinical and research purposes. ● Any other vulnerable subject at the time of enrollment as specified above
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, 1 recruiting
- Recruiting
Weissman Hood Institute at Touro University
Great Falls, Montana, 59405
Director, 406-454-6016, thmcbain@mclaughlinresearch.org
About this study
The study aims to explore whether data driven, personalized wellness interventions-based on integrated genomic, clinical, behavioral, and functional data- are feasible in a rural facing setting and can produce measurable improvements in cardiometabolic, cognitive, mental health, and functional wellness outcomes within four months.
This study has three primary goals.
- Identify scientific, behavioral, operational, and institutional learnings to inform future, larger-scale precision health research.
- Explore how data from diverse rural populations can contribute to understanding diseases and resilience factors across environments.
- Build frameworks for scalable community engagement, data collection, and feedback models.
Read the detailed description
Lifestyle interventions that demonstrate efficacy in clinical trials often require modification for use in outpatient or community-based settings in the real world. Indeed, implementation in rural populations will require identifying logistical adaptations with the least potential to impact efficacy. Taken together, this study aims to address key gaps in implementing personalized wellness approaches in rural populations. With this study, investigators will integrate genomic, clinical, behavioral, and functional data to support personalized wellness interventions, addressing key scientific and behavioral questions, as outlined below. The DRIVE study, will addresses the following questions:
- Scientifically
- Does genomic, clinical, behavioral, and functional data from rural adults provide relevant precision health insights?
- Do physical, mental and cognitive health risks, trajectories, or clinical data points differ between rural populations and prior (non-rural) study findings? If so, are there more informative biomarkers for rural populations?
- What biological, behavioral, and environmental interventions are most influential for increased health metrics and outcomes in rural populations?
- Behaviorally
- Examine recruiting, engagement, retention, and compliance. Identify motivational factors and barriers to each.
- Understand the impact of coaching and other feedback approaches on participant anxiety and empowerment.
- Identify participant perspective re: the number of assessments and participatory requirements
- Conditions
- Healthy Adult
- Being tested
- Data-driven lifestyle coaching
- Keywords
- Lifestyle Intevention, Rural, Phenomic, Genomic, Personalized, Wellness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data-driven lifestyle coachingOther
Using the combination of an individual's biological data (including genomics), activity data, behavioral data, and other incoming streams of health information, the health advocate will tailor the lifestyle intervention for each participant. All information to support healthy behavior will be based on standard, published, and well-researched health data.
| Study group | Role | What they receive |
|---|---|---|
| Data-driven lifestyle intervention | Experimental | Individuals will complete genomic and phenomic assessments and then meet with a health advocate to guide personalized wellness action plans over a 4 month period. Receives: Other: Data-driven lifestyle coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Percentage of individuals enrolled of total inviduals screened
Measured: 4 months
Retention rate
Percentage of individuals enrolled that complete the study
Measured: 4 months
Data completeness
Percentage of total enrolled individuals that complete each assay and assessment
Measured: 4 months
Wearable device adherence
Percentage of time each individual wears the wearable device
Measured: 4 months
Health advocate session completion rates
Percentage of planned health advocate sessions that participants attend
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start15 Jul 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McLaughlin Research Institute for Biomedical Sciences, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872995
- Sponsor's protocol ID
- MRI010
- Acronym
- DRIVE
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant level data collected during the trial will be shared at the time of publication of the results as supplemental material or in publicly available databases.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-driven Rural Interventions for Vitality and Endurance Pilot Study
- ClinicalTrials.gov ID
- NCT07872995
- Acronym / sponsor ID
- DRIVE / MRI010
- Conditions
- Healthy Adult
- Keywords
- Lifestyle Intevention, Rural, Phenomic, Genomic, Personalized, Wellness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McLaughlin Research Institute for Biomedical Sciences, Inc.University, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Oct 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.
The study aims to explore whether data driven, personalized wellness interventions-based on integrated genomic, clinical, behavioral, and functional data- are feasible in a rural facing setting and can produce measurable improvements in cardiometabolic, cognitive, mental health, and functional wellness outcomes within four months.
This study has three primary goals.
- Identify scientific, behavioral, operational, and institutional learnings to inform future, larger-scale precision health research.
- Explore how data from diverse rural populations can contribute to understanding diseases and resilience factors across environments.
- Build frameworks for scalable community engagement, data collection, and feedback models.
Detailed description
Lifestyle interventions that demonstrate efficacy in clinical trials often require modification for use in outpatient or community-based settings in the real world. Indeed, implementation in rural populations will require identifying logistical adaptations with the least potential to impact efficacy. Taken together, this study aims to address key gaps in implementing personalized wellness approaches in rural populations. With this study, investigators will integrate genomic, clinical, behavioral, and functional data to support personalized wellness interventions, addressing key scientific and behavioral questions, as outlined below. The DRIVE study, will addresses the following questions:
- Scientifically
- Does genomic, clinical, behavioral, and functional data from rural adults provide relevant precision health insights?
- Do physical, mental and cognitive health risks, trajectories, or clinical data points differ between rural populations and prior (non-rural) study findings? If so, are there more informative biomarkers for rural populations?
- What biological, behavioral, and environmental interventions are most influential for increased health metrics and outcomes in rural populations?
- Behaviorally
- Examine recruiting, engagement, retention, and compliance. Identify motivational factors and barriers to each.
- Understand the impact of coaching and other feedback approaches on participant anxiety and empowerment.
- Identify participant perspective re: the number of assessments and participatory requirements
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data-driven lifestyle intervention | Experimental | Other: Data-driven lifestyle coachingIndividuals will complete genomic and phenomic assessments and then meet with a health advocate to guide personalized wellness action plans over a 4 month period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults >18 years of age or older at enrollment ● Weight is greater than or equal to 110 lbs
- Able and willing to comprehend and sign the informed consent document
- Able and willing to perform required physical performance tests
- Able and willing to provide study samples
- Able and willing to participate in study procedures
Key exclusion criteria (6 listed)
- A diagnosis of dementia
- Self-reported pregnancy or breastfeeding
- Individuals not fluent in written and spoken English
- Self-reported chronic or end-stage disease that would interfere with their participation in the study
- Severe and non-correctable hearing and visual impairment that would interfere with the ability to complete study measures
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 |
|---|---|---|
| Data-driven lifestyle coachingUsing the combination of an individual's biological data (including genomics), activity data, behavioral data, and other incoming streams of health information, the health advocate will tailor the lifestyle intervention for each participant. All information to support healthy behavior will be based on standard, published, and well-researched health data. | Other | Data-driven lifestyle intervention |
Primary outcome
Enrollment rate
Time frame: 4 months
Percentage of individuals enrolled of total inviduals screened
Retention rate
Time frame: 4 months
Percentage of individuals enrolled that complete the study
Data completeness
Time frame: 4 months
Percentage of total enrolled individuals that complete each assay and assessment
Wearable device adherence
Time frame: 4 months
Percentage of time each individual wears the wearable device
Health advocate session completion rates
Time frame: 4 months
Percentage of planned health advocate sessions that participants attend
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 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant level data collected during the trial will be shared at the time of publication of the results as supplemental material or in publicly available databases.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data-driven lifestyle coaching in people with Healthy Adult, run by McLaughlin Research Institute for Biomedical Sciences, Inc. 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Oct 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?
Contact Tiffany R Hensley-McBain, PhD (406-454-6016, thmcbain@mclaughlinresearch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.