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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03707197
Other study ID # Meditation and Eating
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2018
Est. completion date September 11, 2020

Study information

Verified date November 2020
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 943
Est. completion date September 11, 2020
Est. primary completion date September 11, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of California, Los Angeles Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Los Angeles Headspace Meditation Limited, UCLA Healthy Campus Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reductions in perceived stress as measured by the Perceived Stress Scale Changes in the Perceived Stress Scale (range: 1-40; Cohen, Kamarck, & Mermelstein, 1988). Higher scores indicate greater psychological distress. Baseline to post-intervention (8 weeks from baseline)
Secondary Reductions in stress-induced eating as measured by the Palatable Eating Motives Scale 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. Baseline to post-intervention (8 weeks from baseline)
Secondary Reductions in reward-based eating as measured by the Reward-based Eating Drive 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. Baseline to post-intervention (8 weeks from baseline)