NCT03945214: SFUC+Health

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

Completed NA Results posted Last updated 28 August 2023

What this trial tests

NA trial testing Meditation in Stress in 163 participants. Completed in 1 March 2021.

Timeline

14 February 2019

Primary endpoint
19 May 2020

1 March 2021

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	163
Start date	14 February 2019
Primary completion	19 May 2020
Estimated completion	1 March 2021
Sites	1 location across United States

Drugs / interventions tested

• Meditation
• Healthy Eating
• Meditation + healthy eating

Conditions studied

• Stress — all drugs for Stress →
• Psychological — all drugs for Psychological →
• Behavioral Symptoms — all drugs for Behavioral Symptoms →
• Sleep — all drugs for Sleep →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Stress or Psychological. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale Primary · 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

Group	Value	95% CI
Meditation Group	-5.972	± 0.944
Healthy Eating Group	-2	± 0.931
Mediation + Healthy Eating Group	-4.97	± 0.986
Waitlist Control Condition	-1.658	± 0.919

Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ Primary · 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.

Group	Value	95% CI
Meditation Group	0.257	± 1.372
Healthy Eating Group	1.8	± 1.372
Mediation + Healthy Eating Group	-0.828	± 1.507
Waitlist Control Condition	0.8108	± 1.334

Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale) Secondary · 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..

Group	Value	95% CI
Meditation Group	-1.576	± 0.534
Healthy Eating Group	-1.056	± 0.512
Mediation + Healthy Eating Group	-2.242	± 0.534
Waitlist Control Condition	-0.054	± 0.505

Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale Secondary · 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.

Group	Value	95% CI
Meditation Group	0.508	± 0.116
Healthy Eating Group	0.253	± 0.112
Mediation + Healthy Eating Group	0.423	± 0.122
Waitlist Control Condition	-0.013	± 0.108

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) Secondary · 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.

Group	Value	95% CI
Meditation Group	-0.573	± 0.168
Healthy Eating Group	-0.044	± .16
Mediation + Healthy Eating Group	-0.339	± .168
Waitlist Control Condition	-0.135	± .154

Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r) Secondary · 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.

Group	Value	95% CI
Meditation Group	-9	± 1.926
Healthy Eating Group	-5.939	± 1.836
Mediation + Healthy Eating Group	-7.483	± 1.959
Waitlist Control Condition	-4.378	± 1.734

Sponsor's own 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of digital meditation on work stress and health outcomes among adults with overweight: A randomized controlled trial.
   Radin RM, Epel ES, Mason AE, Vaccaro J, et al · · 2023 · cited 4× · PMID 36857330 · DOI 10.1371/journal.pone.0280808