Behavioral Symptoms, Health Behavior, Psychological, Sleep, Stress, Weight, Body
Conditions
Keywords
Stress, Health, Meditation, Eating, Mindfulness, Employees, Job strain, Burnout, Work, Mood, Affect, Work related stress, Blood pressure, Inflammation
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
Interventions
BEHAVIORALMeditation
10 minute per day, 8 week digital meditation
BEHAVIORALHealthy 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
BEHAVIORALMeditation + 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
Sponsors
The University of California's Healthy Campus Network
Headspace, Inc
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Investigator will be blind to condition throughout data accrual
Intervention model description
Randomization to one of 4 conditions: 1. Digital meditation condition 2. Healthy eating condition 3. Digital meditation + healthy eating condition 4. Wait-list control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale | 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 |
| Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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.. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Meditation: 10 minute per day, 8 week digital meditation | 38 |
| 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.
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 | 41 |
| 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.
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 | 40 |
| Waitlist Control Condition Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. | 42 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 | 7 | 4 |
Baseline characteristics
| Characteristic | Meditation Group | Healthy Eating Group | Mediation + Healthy Eating Group | Waitlist Control Condition | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 39 Participants | 40 Participants | 42 Participants | 158 Participants |
| Age, Continuous | 38.63 years STANDARD_DEVIATION 11.01 | 39.29 years STANDARD_DEVIATION 12.43 | 35.40 years STANDARD_DEVIATION 8.03 | 38.33 years STANDARD_DEVIATION 12.55 | 37.92 years STANDARD_DEVIATION 11.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 6 Participants | 2 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 36 Participants | 34 Participants | 40 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 8 Participants | 13 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 7 Participants | 7 Participants | 4 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 23 Participants | 19 Participants | 20 Participants | 22 Participants | 84 Participants |
| Region of Enrollment United States | 38 participants | 41 participants | 40 participants | 42 participants | 161 participants |
| Sex: Female, Male Female | 27 Participants | 34 Participants | 27 Participants | 28 Participants | 116 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 13 Participants | 14 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 41 | 0 / 41 | 0 / 42 |
| other Total, other adverse events | 0 / 39 | 0 / 41 | 0 / 41 | 0 / 42 |
| serious Total, serious adverse events | 0 / 39 | 0 / 41 | 0 / 41 | 0 / 42 |
Outcome results
Primary
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.
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 136 total participants completed both baseline and follow-up (8 week) measures of the FAAQ.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ | 0.257 units on a scale | Standard Error 1.372 |
| Healthy Eating Group | Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ | 1.8 units on a scale | Standard Error 1.372 |
| Mediation + Healthy Eating Group | Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ | -0.828 units on a scale | Standard Error 1.507 |
| Waitlist Control Condition | Change in Food Action and Acceptance and Action Questionnaire (FAAQ), as Determined by the Summary Score on the FAAQ | 0.8108 units on a scale | Standard Error 1.334 |
Primary
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
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 144 total participants completed both baseline and follow-up (8 week) measures of PSS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale | -5.972 units on a scale | Standard Error 0.944 |
| Healthy Eating Group | Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale | -2 units on a scale | Standard Error 0.931 |
| Mediation + Healthy Eating Group | Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale | -4.97 units on a scale | Standard Error 0.986 |
| Waitlist Control Condition | Change in Perceived Stress Score, as Determined by the Total Score on the Perceived Stress Scale | -1.658 units on a scale | Standard Error 0.919 |
Secondary
Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r)
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.
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 129 total participants completed both baseline and follow-up (8 week) measures of the FCQ-T-r.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r) | -9 units on a scale | Standard Error 1.926 |
| Healthy Eating Group | Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r) | -5.939 units on a scale | Standard Error 1.836 |
| Mediation + Healthy Eating Group | Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r) | -7.483 units on a scale | Standard Error 1.959 |
| Waitlist Control Condition | Change in Food Cravings, as Determined by Total Score on the Trait Food Craving Questionnaire, Reduced (FCQ-T-r) | -4.378 units on a scale | Standard Error 1.734 |
Secondary
Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale
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.
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 132 total participants completed both baseline and follow-up (8 week) measures of the MAAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale | 0.508 units on a scale | Standard Error 0.116 |
| Healthy Eating Group | Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale | 0.253 units on a scale | Standard Error 0.112 |
| Mediation + Healthy Eating Group | Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale | 0.423 units on a scale | Standard Error 0.122 |
| Waitlist Control Condition | Change in Subjective Mindfulness, as Determined by Total Score on the Mindful Attention Awareness Scale | -0.013 units on a scale | Standard Error 0.108 |
Secondary
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)
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.
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 133 total participants completed both baseline and follow-up (8 week) measures of the PEMS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | 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) | -0.573 units on a scale | Standard Error 0.168 |
| Healthy Eating Group | 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) | -0.044 units on a scale | Standard Error 0.16 |
| Mediation + Healthy Eating Group | 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) | -0.339 units on a scale | Standard Error 0.168 |
| Waitlist Control Condition | 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) | -0.135 units on a scale | Standard Error 0.154 |
Secondary
Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale)
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..
Time frame: Baseline to post-intervention, an anticipated average of 8 weeks
Population: Please note that while 163 participants were originally randomized, 2 of those individuals were found to be ineligible post-randomization (due to BMI being measured \<25 kg/m2 during in-person visit). Furthermore, of the 161 participants included in baseline analyses, only 139 total participants completed both baseline and follow-up (8 week) measures of Work Overcommitment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Meditation Group | Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale) | -1.576 units on a scale | Standard Error 0.534 |
| Healthy Eating Group | Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale) | -1.056 units on a scale | Standard Error 0.512 |
| Mediation + Healthy Eating Group | Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale) | -2.242 units on a scale | Standard Error 0.534 |
| Waitlist Control Condition | Change in Work Overcommitment, as Determined by Siegrist Job Strain Scale (Effort-Reward Imbalance Scale) | -0.054 units on a scale | Standard Error 0.505 |