The Lasting Change Study

Resilience, Psychological Clinical Trial

Official title:

The Stanford Lasting Change Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05719129
• Other study ID #: 66491
• Status: Active, not recruiting
• Start date: November 30, 2022
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. The Date With Destiny (DWD) seminar is among the largest worldwide, and tens of thousands of people have already attended and testified to its transformative effect. The main objective of the study is to uncover the underlying mechanism of behavior change through longitudinal data collection of psychometrics Ecological Momentary Assessments, physiology (wearables), and biology (multi-omics) in study participants. The study specific objectives include: (1) To evaluate the impact of DWD on sustainable behavior change; (2) To investigate the mechanism of behavior change by collecting longitudinal real-time measurements of psychometrics (e.g., Ecological Momentary Assessments [EMA]), physiological (e.g., heart rate, blood oxygen level, breathing rate, and EDA), and biological (multi-omics analyses) features in study participants; (3) To assess the effect of the DWD on professional fulfillment, resilience, and mental wellness.

Description:

The work is done partly as the doctorate thesis of Ziv Lautman (Stanford University, Department of Genetics).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Resilience, Psychological
• Wearable Devices

Intervention

Behavioral:
• Date With Destiny (DWD) Seminar
6 days of immersive seminar

Locations

Country	Name	City	State
United States	Stanford university	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental performance biomarker index	An algorithm will be used to create an index score using known biomarkers (psychosocial, physiological, and biological) related to participants' personalized mental performance. Higher index scores will indicate a better mental performance index.	one-year
Secondary	Change in participant mental wellness score	Mental wellness scores rated by participants	baseline through year one
Secondary	Participant resilence score	Resilience scores rated by participants	baseline through year one
Secondary	Participant professional fullfilment score	Professional fulfillment scores rated by participants	baseline through year one
Secondary	Participant self efficacy score	Self-efficacy scores rated by participants	baseline through year one
Secondary	Participant quality of life score	Quality of life scores rated by participants	baseline through year one
Secondary	Participant stress score	Stress scores rated by participants	baseline through year one
Secondary	Participant mindset score	Mindset growth scores rated by participants	baseline through year one
Secondary	Participant goals achievement score	Goal achievement scores rated by participants	baseline through year one
Secondary	Participant human needs score	Human needs fulfillment scores rated by participants	baseline through year one