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The Impact of 8 Weeks of Digital Meditation Application and Healthy Eating Program on Work Stress and Health Outcomes (SFUC+Health)

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ClinicalTrials.gov Identifier: NCT03945214
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
UCSF Healthy Campus Network
Headspace, Inc
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stress Psychological Behavioral Symptoms Sleep Health Behavior Weight, Body Behavioral: Meditation Behavioral: Healthy Eating Behavioral: Meditation + healthy eating Not Applicable

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 as many as 150 participants.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention 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 (Investigator)
Masking Description: Investigator will be blind to condition throughout data accrual
Primary Purpose: Treatment
Official Title: Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Meditation group
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.
Behavioral: Meditation
10 minute per day, 8 week digital meditation

Experimental: Healthy eating group
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.
Behavioral: Healthy Eating
A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals

Experimental: Mediation + Healthy eating group
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.
Behavioral: Meditation + healthy eating
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

No Intervention: Waitlist control condition
Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.



Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Change in job strain, as determined by Siegrist Job Strain Scale [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
    The job strain measure is comprised of two sub scales, effort (5 items) and reward (11 items), each ranging from 1 to 4. The job strain score is calculated as the ratio of demand to reward, with a higher ratio reflecting more job strain.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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 an average of the 15 items. Higher scores reflect greater cravings to eat densely caloric snack.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

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
  • 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

Exclusion Criteria:

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)

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): NCT03945214


Contacts
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Contact: Julie Vaccaro, BS 4154763818 julie.vaccaro@ucsf.edu
Contact: Aric A Prather, PhD 4154767758 aric.prather@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94118
Contact: Sierra Semko    415-476-7758    sierra.semko@ucsf.edu   
Contact: Aric Prather, PhD    4154767758    aric.prather@ucs.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94118
Contact: Julie Vaccaro    415-476-7758    julie.vaccaro@ucsf.edu   
Contact: Rachel Radin, PhD    4154767758    rachel.radin@ucsf.edu   
Principal Investigator: Aric A Prather, PhD         
Principal Investigator: Elissa Epel, PhD         
Sponsors and Collaborators
University of California, San Francisco
UCSF Healthy Campus Network
Headspace, Inc
Investigators
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Principal Investigator: Aric Prather, PhD UC San Francisco
Principal Investigator: Elissa Epel, PhD UC San Francisco
Principal Investigator: Rachel Radin, PhD UC San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03945214     History of Changes
Other Study ID Numbers: 17-23717-2
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 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

Keywords provided by University of California, San Francisco:
Stress
Health
Meditation
Eating
Mindfulness
Employees
Job strain
Burnout
Work
Mood
Affect
Work related stress
Blood pressure
Inflammation

Additional relevant MeSH terms:
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Behavioral Symptoms
Body Weight
Signs and Symptoms