Clinical trial NCT05719129: The Lasting Change Study
Official title: The Stanford Lasting Change Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psychological Wellness
Resilience, Psychological
Personal and Professional Fulfilment
Wearable Devices
Multiomics
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 1445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals that voluntarily chose to participate in DWD seminar.

Brief summary: The study approach is to leverage the most cutting-edge techniques of multi-omics biology, wearable physiology, and digital real-time psychology profiling and using machine learning models to understand the mechanisms underlying the strategies and techniques that enable participants the power to initiate and maintain sustainable behavior change.

Over the years, millions of people worldwide have attended immersive personal development seminars aiming to improve participants' health behaviors and wellness. Nevertheless, there's a scarcity of large-scale studies to assess their effects on behavior change and investigate their mechanism of action. A recent publication by the Science of Behavior Change Program (SOBC), launched by the National Institute of Health (NIH), recognized that: "science has not yet delivered a unified understanding of basic mechanisms of behavior change across a broad range of health-related behaviors, limiting progress in the development and translation of effective and efficacious behavioral intervention." As such, understanding the mechanisms underlying sustainable behavior change is key.


Eligibility criteria: Inclusion Criteria:

* 18-years-old and older
* English speaker
* Live in the US
* Participate in the DWD seminar (December 2-7, 2022)

Exclusion Criteria:

* Any physical or mental condition that limits the ability to participate in the study (e.g., answering e-questionnaires and wearing an electronic device)
* Serious active comorbidity or terminal illness
* Pregnancy
* Participation in any other clinical study focusing on psychological or behavioral intervention.

Primary outcomes:
measure: Mental performance biomarker index.
timeFrame: one-year
measure: Change from baseline in Oldenburg Burnout Inventory score (OLBI)
timeFrame: baseline through year one
measure: Change from baseline in Percieved Stress Scale score (PSS-10)
timeFrame: baseline through year one
measure: Change from baseline in well-being score.
timeFrame: baseline through year one
measure: Change from baseline in subjective health score.
timeFrame: baseline through year one
Secondary outcomes:
measure: Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-10)
timeFrame: baseline through year one
measure: Change from baseline in General Self-Efficacy Scale (GSE-10)
timeFrame: baseline through year one
measure: Change from baseline in Gratitude Questionnaire-Six Item Form (GQ-6)
timeFrame: baseline through year one
measure: Ecological Momentary Assessments (EMAs) score
timeFrame: baseline through year one
measure: Professional Fulfillment Index (PFI) score
timeFrame: baseline through year one
measure: WHO Quality of Life (WHO-QoL-BREF-26) score
timeFrame: baseline through year one
measure: Growth-Fixed Mindset score
timeFrame: baseline through year one
measure: Goals attainment score
timeFrame: baseline through year one
measure: Human Needs score
timeFrame: baseline through year one
measure: Participants experiences and 0pinions
timeFrame: Up to 5 years after completion of the intervention
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford university
state: California
Study officials:
affiliation: Stanford University
name: Mike Snyder, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University & Tel-Aviv University
name: Shahar Lev-Ari, PhD
role: PRINCIPAL_INVESTIGATOR
References: