The Lasting Change Study

NCT05719129 | Active Not Recruiting

• 1 other identifier: 66491, 68645
• Study Type: observational
• Target: 1,445
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Wellness; Resilience, Psychological; Personal and Professional Fulfilment; Wearable Devices; Multiomics

Outcome Measures

Primary Outcomes (5)

• 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. This outcome is assessed in the DWD group only.

  one-year

• Change from baseline in Oldenburg Burnout Inventory score (OLBI)

  Participant self-report burnout assessed by OBLI survey, a 16-item questionarie assesing disengagement and exhaustion with a score range of 16-64, where higher scores indicate higher burnout; assessed in all participants.

  baseline through year one

• Change from baseline in Percieved Stress Scale score (PSS-10)

  Participant self-report perceived stress assessed by the Perceived Stress Scale (PSS-10), a 10-item questionnaire with a score range of 0-40, where higher scores indicate greater perceived stress; assessed in all participants.

  baseline through year one

• Change from baseline in well-being score.

  Participant self-report well-being assessed by the PERMA-H Profiler, a 23-item questionnaire measuring psychological well-being across five domains: positive and negative emotions, engagement, relationships, meaning, and accomplishment (range 0-10 per item, higher scores indicate greater well-being); assessed in all participants.

  baseline through year one

• Change from baseline in subjective health score.

  Participant self-report subjective health assessed by the health domain in the PERMA-H Profiler (range 0-10 per item, higher scores indicate higher subjective health); assessed in all participants.

  baseline through year one

Secondary Outcomes (10)

• Change from baseline in Connor-Davidson Resilience Scale (CD-RISC-10)

  baseline through year one

• Change from baseline in General Self-Efficacy Scale (GSE-10)

  baseline through year one

• Change from baseline in Gratitude Questionnaire-Six Item Form (GQ-6)

  baseline through year one

• Ecological Momentary Assessments (EMAs) score

  baseline through year one

• Professional Fulfillment Index (PFI) score

  baseline through year one

Study Arms (2)

DWD participants

Individuals that voluntarily chose to participate in DWD seminar.

Behavioral: Date With Destiny (DWD) Seminar

Matched control group

Individuals that voluntarily chose to from the US population matched by gender, age, education, ethnicity and income

Interventions

Date With Destiny (DWD) Seminar BEHAVIORAL

6 days of immersive seminar

DWD participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals that voluntarily chose to participate in DWD seminar.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford university

Palo Alto, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A subgroup of up to 300 participants will also undergo a microbiome sampling and will provide saliva and fasted blood samples at (see details below): (a) up to two weeks before DWD, as baseline; (b) at the end of the event. (c) one month after the event; (d) 3 months after the event; (e) 6 months after the event; (f) and one year after the event.

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Chronology as Topic

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Time; Physical Phenomena

Study Officials

• Mike Snyder, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Shahar Lev-Ari, PhD

  Stanford University & Tel-Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Dept. of Genetics

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 8, 2023
• Study Start: November 30, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)