Recruiting

Observational Study

Sponsor:

McLaughlin Research Institute for Biomedical Sciences, Inc.

Code:

NCT07872995

Conditions

Healthy Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Data-driven lifestyle coaching

Study Details

Brief 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 four months.

This study has three primary goals.

1. Identify scientific, behavioral, operational, and institutional learnings to inform future, larger-scale precision health research.
2. Explore how data from diverse rural populations can contribute to understanding diseases and resilience factors across environments.
3. Build frameworks for scalable community engagement, data collection, and feedback models.

Conditions

Healthy Adult

Study ID

NCT07872995

Start date

Jul 15, 2026

Status verified date

Oct, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Data-driven lifestyle intervention

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.

Interventions

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.

Primary outcome measure

  • Enrollment rate [ Time Frame: 4 months ]
  • Retention rate [ Time Frame: 4 months ]
  • Data completeness [ Time Frame: 4 months ]
  • Wearable device adherence [ Time Frame: 4 months ]
  • Health advocate session completion rates [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Tiffany R Hensley-McBain, PhD

406-454-6016thmcbain@mclaughlinresearch.org

Locations

Weissman Hood Institute at Touro University

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Director

406-454-6016thmcbain@mclaughlinresearch.org

More Information

Sponsor

McLaughlin Research Institute for Biomedical Sciences, Inc.

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • Lifestyle Intevention
  • Rural
  • Phenomic
  • Genomic
  • Personalized
  • Wellness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by McLaughlin Research Institute for Biomedical Sciences, Inc. on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.