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Guided Meditation and Stress-Induced Eating

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ClinicalTrials.gov Identifier: NCT03707197
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
UCLA Healthy Campus Network
Headspace Meditation Limited
Information provided by (Responsible Party):
A. Janet Tomiyama, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Stress-induced Eating Behavioral: Meditation Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization to either digital meditation condition or waitlist-control condition
Masking: Single (Investigator)
Masking Description: Investigator will be blind to condition throughout data accrual.
Primary Purpose: Treatment
Official Title: The Impact of 8 Weeks of a Digital Meditation Application on Stress-Induced Eating
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

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
Behavioral: Meditation
Ten minutes of meditation per day for 8 weeks using a mobile application

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



Primary Outcome Measures :
  1. Reductions in perceived stress as measured by the Perceived Stress Scale [ Time Frame: Baseline to post-intervention (8 weeks from baseline) ]
    Changes in the Perceived Stress Scale (range: 1-40; Cohen, Kamarck, & Mermelstein, 1988). Higher scores indicate greater psychological distress.


Secondary Outcome Measures :
  1. 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.

  2. Reductions in reward-based eating as measured by the Reward-based Eating Drive [ Time Frame: Baseline to post-intervention (8 weeks from baseline) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707197


Contacts
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Contact: Janet Tomiyama, Ph.D. 3108259092 tomiyama@ucla.edu
Contact: Lauren T Hofschneider, MA 6269913075 lhofschneider@ucla.edu

Locations
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United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Lauren T Tiongco-Hofschneider, MA    626-991-3075    lhofschneider@ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
UCLA Healthy Campus Network
Headspace Meditation Limited
Investigators
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Principal Investigator: Janet Tomiyama, Ph.D. University of California, Los Angeles

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Responsible Party: A. Janet Tomiyama, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03707197     History of Changes
Other Study ID Numbers: Meditation and Eating
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No