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Completed

NCT Number: NCT03945214

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Body Weight Burnout, Psychological Health Behavior Inflammation Occupational Diseases Occupational Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Psychological Signs and Symptoms Sleep Stress, Psychological Weight, Body

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Meditation

Behavioral

10 minute per day, 8 week digital meditation

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

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

Primary outcomes

  1. Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale

    Time frame: 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

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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..

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

    Time frame: 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.

  3. 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)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SFUC+Health

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 10, 2019
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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