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

NCT03945214 | Completed Results

• 2 other identifiers: 17-23717-2K23AT011048-01
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stress; Health; Meditation; Eating; Mindfulness; Employees; Job strain; Burnout; Work; Mood; Affect; Work related stress; Blood pressure; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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

  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)

  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)

  Baseline to post-intervention, an anticipated average of 8 weeks

Study Arms (4)

Meditation group

EXPERIMENTAL

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

Healthy eating group

EXPERIMENTAL

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

Mediation + Healthy eating group

EXPERIMENTAL

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

Waitlist control condition

NO INTERVENTION

Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.

Interventions

Meditation BEHAVIORAL

10 minute per day, 8 week digital meditation

Meditation group

Healthy Eating BEHAVIORAL

A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals

Healthy eating group

Meditation + healthy eating BEHAVIORAL

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

Mediation + Healthy eating group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• The University of California's Healthy Campus Network: collaborator
• Headspace, Inc: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (1)

• Radin RM, Epel ES, Mason AE, Vaccaro J, Fromer E, Guan J, Prather AA. Impact of digital meditation on work stress and health outcomes among adults with overweight: A randomized controlled trial. PLoS One. 2023 Mar 1;18(3):e0280808. doi: 10.1371/journal.pone.0280808. eCollection 2023.

  PMID: 36857330 DERIVED

MeSH Terms

Conditions

Behavioral Symptoms; Health Behavior; Body Weight; Occupational Stress; Burnout, Psychological; Inflammation

Interventions

Meditation; Diet, Healthy

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Occupational Diseases; Stress, Psychological; Pathologic Processes

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Rachel Radin
• Organization: University of California San Francisco

rachel.radin@ucsf.edu

845-641-9569

Study Officials

• Aric Prather, PhD

  UC San Francisco

  PRINCIPAL INVESTIGATOR

• Elissa Epel, PhD

  UC San Francisco

  PRINCIPAL INVESTIGATOR

• Rachel Radin, PhD

  UC San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be blind to condition throughout data accrual
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization to one of 4 conditions: 1. Digital meditation condition 2. Healthy eating condition 3. Digital meditation + healthy eating condition 4. Wait-list control

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: February 14, 2019
• Primary Completion: May 19, 2020
• Study Completion: March 1, 2021
• Last Updated: August 28, 2023
• Results First Posted: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)