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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011048-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of California's Healthy Campus Network | OTHER |
| Headspace, Inc | UNKNOWN |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | 10 minute per day, 8 week digital meditation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | Baseline to post-intervention, an anticipated average of 8 weeks |
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Inclusion Criteria:
You may join if you
Exclusion Criteria:
You may not join if you:
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| Name | Affiliation | Role |
|---|---|---|
| Aric Prather, PhD | UC San Francisco | Principal Investigator |
| Elissa Epel, PhD | UC San Francisco | Principal Investigator |
| Rachel Radin, PhD | UC San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36857330 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 |
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Randomization to one of 4 conditions:
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Investigator will be blind to condition throughout data accrual
| 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 |
|
| 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. | 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) | 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. | 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) | 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. | Baseline to post-intervention, an anticipated average of 8 weeks |
| 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 |
| FG002 | 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 |
| FG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
| COMPLETED |
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| NOT COMPLETED |
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Please note that while 163 participants were originally randomized, our total sample for analysis at baseline was 161 participants. This discrepancy is due to the discovery that 2 of the randomized participants were actually ineligible for the study (BMI was <25 kg/m2 when measured in person).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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.. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline to post-intervention, an anticipated average of 8 weeks |
|
1 year
They do not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 39 | 0 | 39 | 0 | 39 |
| EG001 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
| EG002 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
| EG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. | 0 | 42 | 0 | 42 | 0 | 42 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rachel Radin | University of California San Francisco | 845-641-9569 | rachel.radin@ucsf.edu |
| Jul 17, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D015438 | Health Behavior |
| D001835 | Body Weight |
| D000073397 | Occupational Stress |
| D000077062 | Burnout, Psychological |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | 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 |
| OG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
|
|
| OG002 | 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 |
| OG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
|
|
| OG002 | 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 |
| OG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
|
|
| OG002 | 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 |
| OG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
|
|
| OG002 | 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 |
| OG003 | Waitlist Control Condition | Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period. |
|
|