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

NCT ID: NCT03945214

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2021-03-01

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.

Detailed 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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Meditation

Intervention Type: BEHAVIORAL

10 minute per day, 8 week digital meditation

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.

Group Type: EXPERIMENTAL

Healthy Eating

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Meditation + healthy eating

Intervention Type: 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

Waitlist control condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Meditation

10 minute per day, 8 week digital meditation

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of California's Healthy Campus Network

OTHER

Sponsor Role: collaborator

Headspace, Inc

UNKNOWN

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aric Prather, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Elissa Epel, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Rachel Radin, PhD

Role: PRINCIPAL_INVESTIGATOR

UC San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36857330 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23AT011048-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-23717-2

Identifier Type: -

Identifier Source: org_study_id