Clinical trial NCT03945214: The Impact of 8 Weeks of Digital Meditation Application and Healthy Eating Program on Work Stress and Health Outcomes
Official title: Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Psychological
Behavioral Symptoms
Sleep
Health Behavior
Weight, Body
Keywords: Stress
Health
Meditation
Eating
Mindfulness
Employees
Job strain
Burnout
Work
Mood
Affect
Work related stress
Blood pressure
Inflammation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The University of California's Healthy Campus Network
name: Headspace, Inc
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-05-10
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomization to one of 4 conditions:

1. Digital meditation condition
2. Healthy eating condition
3. Digital meditation + healthy eating condition
4. Wait-list control
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

You may join if you

* Have access to a smartphone or computer every day
* Are fluent in English
* Are a UCSF employee
* Report mild to moderate levels of stress (as determined by a Perceived Stress Scale score of 15 or higher)
* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and have received a signed and dated copy of the informed consent form
* Are at least 18 years of age
* Express a willingness to be randomly assigned into the waitlist group or the intervention groups
* Report a Body Mass Index (BMI) of 25 kg/m2 or above

Exclusion Criteria:

You may not join if you:

* Are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)

Primary outcomes:
measure: Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Secondary outcomes:
measure: Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale)
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in the Intentional Use of Palatable Food to Cope With Negative Feelings, as Determined by Total Score on the Palatable Eating Motives, Coping Subscale (PEMS)
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
measure: Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r)
timeFrame: Baseline to post-intervention, an anticipated average of 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: UC San Francisco
name: Aric Prather, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC San Francisco
name: Elissa Epel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC San Francisco
name: Rachel Radin, PhD
role: PRINCIPAL_INVESTIGATOR
References: