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

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Behavioral: Meditation + healthy eating; Behavioral: Meditation; Behavioral: Healthy Eating

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03945214

K23AT011048-01 (U.S. NIH Grant/Contract)

17-23717-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

163 participants in 4 patient groups

Meditation group

Experimental group

Description:

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.

Treatment:

Behavioral: Meditation

Healthy eating group

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Eating

Mediation + Healthy eating group

Experimental group

Description:

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.

Treatment:

Behavioral: Meditation + healthy eating

Waitlist control condition

No Intervention group

Description:

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