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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT03945214

Collaborator

UCSF Healthy Campus Network (Other), Headspace, Inc (Other)

164

Enrollment

Location

Arms

24.5

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

164 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Randomization to one of 4 conditions: Digital meditation condition Healthy eating condition Digital meditation + healthy eating condition Wait-list controlRandomization to one of 4 conditions:Digital meditation condition Healthy eating condition Digital meditation + healthy eating condition 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 :

Feb 14, 2019

Actual Primary Completion Date :

May 19, 2020

Actual Study Completion Date :

Mar 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Change in perceived stress score, as determined by the total score on the Perceived Stress Scale [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 [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

Change in job strain, as determined by Siegrist Job Strain Scale [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.
Change in subjective mindfulness, as determined by total score on the Mindful Attention Awareness Scale [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.
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) [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.
Change in food cravings, as determined by total score on the trait food craving questionnaire, reduced (FCQ-T-r) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)