NCT03695263

Massive Individualized N-of-1 Experiments (MINEs)

Massive Individualized N-of-1 Experiments Using HackYourHealth: A New Paradigm for Promoting Health and Well-Being

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 483 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The project will enroll up to 10,000 adult volunteers in individualized experiments (N-of-1 trials) designed to assess the individual-level effects of any of five interventions on three outcomes. The five interventions are: gratitude journaling, mindfulness meditation, random acts of kindness, physical activity, and laughter therapy. The three outcomes are stress, cognitive focus, and happiness. Each participant will engage in the selected activity in 3 day intervals, separated at random by 3 day intervals of usual activity, for a total of six 3-day periods (18 days).

Detailed description

N-of-1 trials (single patient crossover experiments) are a uniquely powerful technique for estimating treatment effects in the individual. N-of-1 trials have been offered to hundreds or perhaps thousands of patients worldwide, but never at scale. HackYourHealth is a tool that supports the conduct of simple N-of-1 self-experiments to test if healthy activities that work in general (i.e., mindfulness meditation, physical activity, gratitude journaling, random acts of kindness, and laughter therapy), improve psychological well-being (stress, focus, happiness) in specific individuals. The tool supplies the experimental design, facilitates data analysis, and channels feedback to participants. The tool is flexible enough to support Massive Individualized N-of-1 Experiments (MINEs) at scale. Working with WNYC Radio in New York City, we will recruit and run 18-day N-of-1 trials up to 10,000 individuals. The purpose of this study is to conduct a formative evaluation of HackYourHealth in terms of its perceived usefulness and to explore heterogeneity in intervention response across the sample. We anticipate that the results will: 1) identify useful behavioral interventions for individual participants; 2) help to estimate generalizable treatment effects for the interventions of interest; 3) assess heterogeneity of treatment effects across subgroups; and 4) elucidate the user experience with N-of-1 trials. When complete, the study will support additional proposals designed to assess the utility of MINEs as applied to additional conditions and treatments.

Conditions

• Stress, Psychological
• Happiness
• Cognition

Interventions

Type	Name	Description
BEHAVIORAL	Choice of one of five behavioral interventions	All participants will choose one of the five intervention options.

Timeline

• Start date: 2019-04-15
• Primary completion: 2019-11-30
• Completion: 2019-12-30
• First posted: 2018-10-04
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States