Clinical Trials Directory

Trials / Completed

CompletedNCT03945214

The Impact of 8 Weeks of Digital Meditation Application and Healthy Eating Program on Work Stress and Health Outcomes

Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort

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

Summary

The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI\>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.

Detailed description

The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI\>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition. Participants assigned to the digital meditation intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. Participants assigned to the healthy eating intervention group will be asked to participate in a 50 minute motivational interviewing counseling session centered around healthy eating behaviors , three 10-minute booster phone calls at weeks 1, 4, and 8, and weekly participation in a digital mindful eating activity. All study participants will be asked to fill out questionnaires at baseline, week 4, week 8 (post-intervention), and a 4-month follow-up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow-up assessment. Physiological assessments (body composition, blood spot) will be obtained at an in-person clinic visit at baseline and week 8. Fitness, sleep, and mood data will be gathered for seven consecutive days at baseline and week 8. Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. Adherence in the digital meditation intervention will be tracked remotely. The goal is to recruit up to 165 participants

Conditions

Interventions

TypeNameDescription
BEHAVIORALMeditation10 minute per day, 8 week digital meditation
BEHAVIORALHealthy EatingA single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals
BEHAVIORALMeditation + healthy eating10 minute per day, 8 week digital meditation and a single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals

Timeline

Start date
2019-02-14
Primary completion
2020-05-19
Completion
2021-03-01
First posted
2019-05-10
Last updated
2023-08-28
Results posted
2023-08-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03945214. Inclusion in this directory is not an endorsement.