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

Stress Clinical Trial

— SFUC+Health  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945214
• Other study ID #: 17-23717-2
• Secondary ID: K23AT011048-01
• Status: Completed
• Phase: N/A
• Start date: February 14, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 1, 2021
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Meditation
10 minute per day, 8 week digital meditation
• 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
• 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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	Headspace, Inc, National Center for Complementary and Integrative Health (NCCIH), UCSF Healthy Campus Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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