StressSFUC+HealthNCT03945214
The Impact of 8 Weeks of Digital Meditation Application and Healthy Eating Program on Work Stress and Health Outcomes
A study testing Meditation, Healthy Eating and Meditation + healthy eating in people with Stress and Psychological, run by University of California, San Francisco at 1 site in United States.
Trial summary
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Behavioral Symptoms
- What is being tested?
- Meditation, Healthy Eating and Meditation + healthy eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- You may join if you
- Have access to a smartphone or computer every day
- Are fluent in English
- Are a UCSF employee
- Report mild to moderate levels of stress (as determined by a Perceived Stress Scale score of 15 or higher)
- Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and have received a signed and dated copy of the informed consent form
Show all 9Show fewer
- Are at least 18 years of age
- Express a willingness to be randomly assigned into the waitlist group or the intervention groups
- Report a Body Mass Index (BMI) of 25 kg/m2 or above
Who cannot join
- You may not join if you:
- Are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
Official title: Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
Read the detailed description
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
Participants assigned to the digital meditation intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. Participants assigned to the healthy eating intervention group will be asked to participate in a 50 minute motivational interviewing counseling session centered around healthy eating behaviors , three 10-minute booster phone calls at weeks 1, 4, and 8, and weekly participation in a digital mindful eating activity.
All study participants will be asked to fill out 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 assessment. Physiological assessments (body composition, blood spot) will be obtained at an in-person clinic visit at baseline and week 8. Fitness, sleep, and mood data will be gathered for seven consecutive days at baseline and week 8.
Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. Adherence in the digital meditation intervention will be tracked remotely. The goal is to recruit up to 165 participants
- Conditions
- Stress, Psychological, Behavioral Symptoms, Sleep, Health Behavior, Weight, Body
- Being tested
- Meditation, Healthy Eating, Meditation + healthy eating
- Keywords
- Stress, Health, Meditation, Eating, Mindfulness, Employees, Job strain, Burnout, Work, Mood, Affect, Work related stress, Blood pressure, Inflammation
- Medical subject headings
- Behavioral Symptoms, Health Behavior, Body Weight, Occupational Stress, Burnout, Psychological, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
10 minute per day, 8 week digital meditation
Healthy EatingBehavioural
A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals
Meditation + healthy eatingBehavioural
10 minute per day, 8 week digital meditation and a single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals
| Study group | Role | What they receive |
|---|---|---|
| Meditation group | Experimental | Participants in the meditation intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks. Receives: Behavioral: Meditation |
| Healthy eating group | Experimental | Participants in the healthy eating group will be required to attend an in-person 50-minute counseling session geared towards developing goals to improve eating behavior, along with three 10-minute booster phone calls at weeks 1, 4, and 8. They will be asked to engage with a digital-based mindful eating program once per week over the course of 8 weeks. Receives: Behavioral: Healthy Eating |
| Mediation + Healthy eating group | Experimental | Participants in the meditation + healthy eating intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks. They will also be required to attend an in-person 50-minute counseling session geared towards developing goals to improve eating behavior, along with three 10-minute booster phone calls at weeks 1, 4, and 8. They will be asked to engage with a digital-based mindful eating program once per week over the course of 8 weeks. Receives: Behavioral: Meditation + healthy eating |
| Waitlist control condition | No intervention | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ
The Food Acceptance and Action Questionnaire has a total score scale range of 10 to 60, with higher scores indicating greater acceptance of motivations to eat.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Secondary outcomes (4)
Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale)
The job strain- overcommitment measure (6 items) has items ranging from 1 to 4 (total score ranges from 6-24). The job strain-overcommitment score is calculated as the sum of items 17-22, with higher scores reflecting greater likelihood of experiencing over-commitment at work..
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale
The Mindful Attention Awareness Scale is a 15-item measure with each item ranging from a score of 1 to 6. To score the scale, we compute the average score across items, with a higher score reflecting higher levels of mindfulness.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in the Intentional Use of Palatable Food to Cope With Negative Feelings, as Determined by Total Score on the Palatable Eating Motives, Coping Subscale (PEMS)
The Palatable Eating Motives, Coping Subscale is a 4-item measure, with each item ranging from 1 (almost never/never) to 5 (almost always/always). A total coping sub scale score is determined by an average of the 4 items. Higher scores reflect greater use of palatable food to cope with negative emotions.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r)
The Trait Food Craving Questionnaire, reduced, is a 15-item measure of behavioral, cognitive, and physical aspects of cravings for different types of food. Item response choices range from 0 (never) to 5 (always), and the total score is a sum of the 15 items (total score ranges from 0-75). Higher scores reflect greater cravings to eat densely caloric snack.
Measured: Baseline to post-intervention, an anticipated average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start14 Feb 2019
- Primary completion19 May 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Factorial
- Model description
- Randomization to one of 4 conditions: 1. Digital meditation condition 2. Healthy eating condition 3. Digital meditation + healthy eating condition 4. Wait-list control
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace, Inc, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Aric Prather, PhD, Principal investigator, UC San FranciscoElissa Epel, PhD, Principal investigator, UC San FranciscoRachel Radin, PhD, Principal investigator, UC San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945214
- Sponsor's protocol ID
- 17-23717-2
- Other IDs
- K23AT011048-01
- Acronym
- SFUC+Health
- Status last verified
- Aug 2023
- First submitted
- 8 May 2019
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radin RM, Epel ES, Mason AE, Vaccaro J, Fromer E, Guan J, Prather AA. Impact of digital meditation on work stress and health outcomes among adults with overweight: A randomized controlled trial. PLoS One. 2023 Mar 1;18(3):e0280808. doi: 10.1371/journal.pone.0280808. eCollection 2023.
PubMed 36857330
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort
- ClinicalTrials.gov ID
- NCT03945214
- Acronym / sponsor ID
- SFUC+Health / 17-23717-2
- Conditions
- Stress, Psychological, Behavioral Symptoms, Sleep, Health Behavior, Weight, Body
- Keywords
- Stress, Health, Meditation, Eating, Mindfulness, Employees, Job strain, Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- The University of California's Healthy Campus Network, Headspace, Inc, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Posted 28 Aug 2023
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 the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
Detailed description
The aim of the present study is to test the effects of a digital meditation intervention and/or a healthy eating intervention in a sample of UCSF employees with overweight and obesity (BMI>=25kg/m2) who report mild to moderate stress. We will randomize UCSF employees to 8-weeks of a digital meditation intervention (using the commercially available application, Headspace), a healthy eating intervention, a digital meditation+healthy eating intervention, or a waitlist control condition.
Participants assigned to the digital meditation intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. Participants assigned to the healthy eating intervention group will be asked to participate in a 50 minute motivational interviewing counseling session centered around healthy eating behaviors , three 10-minute booster phone calls at weeks 1, 4, and 8, and weekly participation in a digital mindful eating activity.
All study participants will be asked to fill out 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 assessment. Physiological assessments (body composition, blood spot) will be obtained at an in-person clinic visit at baseline and week 8. Fitness, sleep, and mood data will be gathered for seven consecutive days at baseline and week 8.
Prior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. Adherence in the digital meditation intervention will be tracked remotely. The goal is to recruit up to 165 participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Randomization to one of 4 conditions: 1. Digital meditation condition 2. Healthy eating condition 3. Digital meditation + healthy eating condition 4. Wait-list control
| Arm | Type | Receives |
|---|---|---|
| Meditation group | Experimental | Behavioral: MeditationParticipants in the meditation intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks. |
| Healthy eating group | Experimental | Behavioral: Healthy EatingParticipants in the healthy eating group will be required to attend an in-person 50-minute counseling session geared towards developing goals to improve eating behavior, along with three 10-minute booster phone calls at weeks 1, 4, and 8. They will be asked to engage with a digital-based mindful eating program once per week over the course of 8 weeks. |
| Mediation + Healthy eating group | Experimental | Behavioral: Meditation + healthy eatingParticipants in the meditation + healthy eating intervention group will be assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks. They will also be required to attend an in-person 50-minute counseling session geared towards developing goals to improve eating behavior, along with three 10-minute booster phone calls at weeks 1, 4, and 8. They will be asked to engage with a digital-based mindful eating program once per week over the course of 8 weeks. |
| Waitlist control condition | No intervention | –Waitlist control group participants will continue their normal activities and not add any form of mediation 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 (9 listed)
- You may join if you
- Have access to a smartphone or computer every day
- Are fluent in English
- Are a UCSF employee
- Report mild to moderate levels of stress (as determined by a Perceived Stress Scale score of 15 or higher)
Key exclusion criteria (2 listed)
- Are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 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 |
|---|---|---|
| Meditation10 minute per day, 8 week digital meditation | Behavioural | Meditation group |
| Healthy EatingA single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals | Behavioural | Healthy eating group |
| Meditation + healthy eating10 minute per day, 8 week digital meditation and a single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals | Behavioural | Mediation + Healthy eating group |
Primary outcome
Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress
Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
The Food Acceptance and Action Questionnaire has a total score scale range of 10 to 60, with higher scores indicating greater acceptance of motivations to eat.
4 secondary outcomes
Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale)
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in the Intentional Use of Palatable Food to Cope With Negative Feelings, as Determined by Total Score on the Palatable Eating Motives, Coping Subscale (PEMS)
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r)
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36857330Radin RM, Epel ES, Mason AE, Vaccaro J, Fromer E, Guan J, Prather AA. Impact of digital meditation on work stress and health outcomes among adults with overweight: A randomized controlled trial. PLoS One. 2023 Mar 1;18(3):e0280808. doi: 10.1371/journal.pone.0280808. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Aric Prather, PhD principal investigator
UC San Francisco
Elissa Epel, PhD principal investigator
UC San Francisco
Rachel Radin, PhD principal investigator
UC San Francisco
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, Healthy Eating and Meditation + healthy eating in people with Stress and Psychological, run by University of California, San Francisco 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 9 inclusion and 2 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 28 Aug 2023. 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?
Yes. Results are posted in the registry (first posted 28 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale (time frame: Baseline to post-intervention, an anticipated average of 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03945214, which also lists 1 linked publication.
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 28 Aug 2023.