Clinical trial NCT03707197: Guided Meditation and Stress-Induced Eating
Official title: The Impact of 8 Weeks of a Digital Meditation Application on Stress-Induced Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress-induced Eating
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: The University of California's Healthy Campus Network
name: Headspace Meditation Limited
First posted: 2018-10-16
Enrollment: 943
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to either digital meditation condition or waitlist-control condition
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the effects of a digital meditation intervention in a sample of UCLA employees who report mild to moderate stress. We will randomize University of California Los Angeles employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Detailed description: The aim of this study is to test the effects of a digital meditation intervention in a sample of UCLA employees who report mild to moderate stress. UCLA employees will be randomized to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.

Participants who are assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All participants will be asked to fill out short (no longer than 25 minutes) 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. All activities will take place online (via computer or smartphone).

Prior to randomization, participants will complete an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 1000 participants (500 per condition).

Eligibility criteria: Inclusion Criteria:

* Have access to a smartphone or computer everyday
* Are fluent in English
* Are a University of California, Los Angeles employee
* Report mild to moderate levels of stress
* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent
* Are at least 18 years of age

Exclusion Criteria:

* You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 6 months (defined as once or more per week for a duration of 20 minutes or more at each practice)

Primary outcomes:
measure: Reductions in perceived stress as measured by the Perceived Stress Scale
timeFrame: Baseline to post-intervention (8 weeks from baseline)
Secondary outcomes:
measure: Reductions in stress-induced eating as measured by the Palatable Eating Motives Scale
timeFrame: Baseline to post-intervention (8 weeks from baseline)
measure: Reductions in reward-based eating as measured by the Reward-based Eating Drive
timeFrame: Baseline to post-intervention (8 weeks from baseline)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Janet Tomiyama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: