Stress-induced EatingNCT03707197
Guided Meditation and Stress-Induced Eating
A study testing Meditation in people with Stress-induced Eating, run by University of California, Los Angeles at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress-induced Eating
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 943 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 11 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90024
About this study
Official title: The Impact of 8 Weeks of a Digital Meditation Application on Stress-Induced Eating
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.
Read the 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).
- Conditions
- Stress-induced Eating
- Being tested
- Meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Ten minutes of meditation per day for 8 weeks using a mobile application
| Study group | Role | What they receive |
|---|---|---|
| Meditation Group | Experimental | 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 Receives: Behavioral: Meditation |
| Wait-list Control Group | No intervention | Wait-list control group participants will continue their normal activities and not engage in any form of meditation during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-intervention (8 weeks from baseline)
Secondary outcomes (2)
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.
Measured: Baseline to post-intervention (8 weeks from baseline)
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.
Measured: Baseline to post-intervention (8 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start15 Oct 2018
- Primary completion11 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress-induced EatingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to either digital meditation condition or waitlist-control condition
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace Meditation Limited
- Responsible party
- Principal investigator, A. Janet Tomiyama, University of California, Los Angeles
- Investigators
- Janet Tomiyama, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707197
- Sponsor's protocol ID
- Meditation and Eating
- Status last verified
- Nov 2020
- First submitted
- 9 Oct 2018
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of 8 Weeks of a Digital Meditation Application on Stress-Induced Eating
- ClinicalTrials.gov ID
- NCT03707197
- Acronym / sponsor ID
- Meditation and Eating
- Conditions
- Stress-induced Eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace Meditation Limited
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization to either digital meditation condition or waitlist-control condition
| Arm | Type | Receives |
|---|---|---|
| Meditation Group | Experimental | Behavioral: MeditationThe 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 |
| Wait-list Control Group | No intervention | –Wait-list control group participants will continue their normal activities and not engage in any form of meditation during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeditationTen minutes of meditation per day for 8 weeks using a mobile application | Behavioural | Meditation Group |
Primary outcome
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.
2 secondary outcomes
Reductions in stress-induced eating as measured by the Palatable Eating Motives Scale
Time frame: Baseline to post-intervention (8 weeks from baseline)
Reductions in reward-based eating as measured by the Reward-based Eating Drive
Time frame: Baseline to post-intervention (8 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Tomiyama, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation in people with Stress-induced Eating, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in perceived stress as measured by the Perceived Stress Scale (time frame: Baseline to post-intervention (8 weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020; AzTrials last refreshed its copy on 1 Nov 2026.