- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03707197
Guided Meditation and Stress-Induced Eating
The Impact of 8 Weeks of a Digital Meditation Application on Stress-Induced Eating
Study Overview
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- University of California, Los Angeles
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meditation Group
The intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basic + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks
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Ten minutes of meditation per day for 8 weeks using a mobile application
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No Intervention: Wait-list Control Group
Wait-list control group participants will continue their normal activities and not engage in any form of meditation during the study period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reductions in perceived stress as measured by the Perceived Stress Scale
Time Frame: Baseline to post-intervention (8 weeks from baseline)
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Changes in the Perceived Stress Scale (range: 1-40; Cohen, Kamarck, & Mermelstein, 1988).
Higher scores indicate greater psychological distress.
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Baseline to post-intervention (8 weeks from baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reductions in stress-induced eating as measured by the Palatable Eating Motives Scale
Time Frame: Baseline to post-intervention (8 weeks from baseline)
|
Changes self-reporting using highly palatable foods to cope with stress, according to the Palatable Eating Motives Scale Coping subscale (range: 1-20) Burgess, Turan, Lokken, Morse, & Boggiano, 2014).
Higher scores indicate a higher likelihood of using palatable foods to cope with stress.
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Baseline to post-intervention (8 weeks from baseline)
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Reductions in reward-based eating as measured by the Reward-based Eating Drive
Time Frame: Baseline to post-intervention (8 weeks from baseline)
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Changes in self-reporting intrinsic rewards from consuming highly palatable foods, according to the Reward-based Eating Drive (RED) Scale (range: 1-45; Epel, et al. 2014).
Higher scores indicate a greater reward response from consuming palatable foods.
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Baseline to post-intervention (8 weeks from baseline)
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Collaborators and Investigators
Investigators
- Principal Investigator: Janet Tomiyama, Ph.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Meditation and Eating
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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