An interventional study of Data-driven lifestyle coaching in Healthy Adult, sponsored by McLaughlin Research Institute for Biomedical Sciences, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by McLaughlin Research Institute for Biomedical Sciences, Inc. · Not applicable, Interventional, and Supportive care
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.
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
Behaviorally
McLaughlin Research Institute for Biomedical Sciences, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Data-driven lifestyle coaching
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.
Enrollment rate
Percentage of individuals enrolled of total inviduals screened
Time frame: 4 months
Retention rate
Percentage of individuals enrolled that complete the study
Time frame: 4 months
Data completeness
Percentage of total enrolled individuals that complete each assay and assessment
Time frame: 4 months
Wearable device adherence
Percentage of time each individual wears the wearable device
Time frame: 4 months
Health advocate session completion rates
Percentage of planned health advocate sessions that participants attend
Time frame: 4 months
Plan to share: 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.
Supporting information: Statistical analysis plan
Time frame: Data will become available beginning 9 months after article publication and ending 36 months post-publication.
Access criteria: Deidentified individual participant data, including data dictionaries, will be shared with qualified researchers who provide a methodologically sound research proposal. Requests must include a statistical analysis plan and be approved by an independent review committee. Requesters must sign a data access agreement.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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McLaughlin Research Institute for Biomedical Sciences, Inc.