Guided Meditation and Stress-Induced Eating
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03707197|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress-induced Eating||Behavioral: Meditation||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomization to either digital meditation condition or waitlist-control condition|
|Masking Description:||Investigator will be blind to condition throughout data accrual.|
|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|
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
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
- 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.
- 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.
- 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.
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
|Contact: Janet Tomiyama, Ph.D.||email@example.com|
|Contact: Lauren T Hofschneider, MAfirstname.lastname@example.org|
|United States, California|
|University of California, Los Angeles||Recruiting|
|Los Angeles, California, United States, 90024|
|Contact: Lauren T Tiongco-Hofschneider, MA 626-991-3075 email@example.com|
|Principal Investigator:||Janet Tomiyama, Ph.D.||University of California, Los Angeles|