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

Study Overview
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Brief Summary
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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
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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

Official Title
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Program on Work Stress and Health Outcomes in a Heterogeneous University Employee Cohort

Conditions
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Stress, Psychological, Behavioral Symptoms, Sleep, Health Behavior, Weight, Body

Intervention / Treatment
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* Behavioral: Meditation
* Behavioral: Healthy Eating
* Behavioral: Meditation + healthy eating


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Randomization to one of 4 conditions: Digital meditation condition Healthy eating condition Digital meditation + healthy eating condition Wait-list control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation group<br>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<br>* 10 minute per day, 8 week digital meditation<br>|
| Experimental: Healthy eating group<br>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<br>* A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals<br>|
| Experimental: Mediation + Healthy eating group<br>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<br>* 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<br>|
| No Intervention: Waitlist control condition<br>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?
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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 | 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 | 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) | 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 | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Health, Meditation, Eating, Mindfulness, Employees, Job strain, Burnout, Work, Mood, Affect, Work related stress, Blood pressure, Inflammation