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

August 25, 2023 updated by: University of California, San Francisco

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
Baseline to post-intervention, an anticipated average of 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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..
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
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.
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
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.
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
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.
Baseline to post-intervention, an anticipated average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aric Prather, PhD, UC San Francisco
  • Principal Investigator: Elissa Epel, PhD, UC San Francisco
  • Principal Investigator: Rachel Radin, PhD, UC San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2019

Primary Completion (Actual)

May 19, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 10, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-23717-2
  • K23AT011048-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Behavioral Symptoms

Clinical Trials on Meditation

3
Subscribe