Trial Outcomes & Findings for The Impact of 8 Weeks of Digital Meditation Application and Healthy Eating Program on Work Stress and Health Outcomes (NCT NCT03945214)

NCT ID: NCT03945214

Last Updated: 2023-08-28

Results Overview

The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 163 participants
• Primary outcome timeframe: Baseline to post-intervention, an anticipated average of 8 weeks
• Results posted on: 2023-08-28

Participant Flow

Participant milestones

Measure	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	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	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	Waitlist Control Condition Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
Overall Study STARTED	39	41	41	42
Overall Study COMPLETED	36	37	34	38
Overall Study NOT COMPLETED	3	4	7	4

Reasons for withdrawal

Measure	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	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	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	Waitlist Control Condition Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
Overall Study Lost to Follow-up	3	4	7	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Meditation Group n=38 Participants 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	Healthy Eating Group n=41 Participants 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	Mediation + Healthy Eating Group n=40 Participants 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	Waitlist Control Condition n=42 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.	Total n=161 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	39 Participants n=7 Participants	40 Participants n=5 Participants	42 Participants n=4 Participants	158 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Age, Continuous	38.63 years STANDARD_DEVIATION 11.01 • n=5 Participants	39.29 years STANDARD_DEVIATION 12.43 • n=7 Participants	35.40 years STANDARD_DEVIATION 8.03 • n=5 Participants	38.33 years STANDARD_DEVIATION 12.55 • n=4 Participants	37.92 years STANDARD_DEVIATION 11.18 • n=21 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	34 Participants n=7 Participants	27 Participants n=5 Participants	28 Participants n=4 Participants	116 Participants n=21 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants	14 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	36 Participants n=7 Participants	34 Participants n=5 Participants	40 Participants n=4 Participants	141 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	13 Participants n=4 Participants	32 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	22 Participants n=4 Participants	84 Participants n=21 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment United States	38 participants n=5 Participants	41 participants n=7 Participants	40 participants n=5 Participants	42 participants n=4 Participants	161 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress

Outcome measures

Measure	Meditation Group n=36 Participants 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	Healthy Eating Group n=37 Participants 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	Mediation + Healthy Eating Group n=33 Participants 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	Waitlist Control Condition n=38 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	-2 units on a scale Standard Error 0.931	-4.97 units on a scale Standard Error 0.986	-1.658 units on a scale Standard Error 0.919

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation Group n=35 Participants 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	Healthy Eating Group n=35 Participants 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	Mediation + Healthy Eating Group n=29 Participants 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	Waitlist Control Condition n=37 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	1.8 units on a scale Standard Error 1.372	-0.828 units on a scale Standard Error 1.507	0.8108 units on a scale Standard Error 1.334

SECONDARY outcome

Timeframe: 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.

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..

Outcome measures

Measure	Meditation Group n=33 Participants 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	Healthy Eating Group n=36 Participants 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	Mediation + Healthy Eating Group n=33 Participants 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	Waitlist Control Condition n=37 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	-1.056 units on a scale Standard Error 0.512	-2.242 units on a scale Standard Error 0.534	-0.054 units on a scale Standard Error 0.505

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation Group n=32 Participants 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	Healthy Eating Group n=34 Participants 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	Mediation + Healthy Eating Group n=29 Participants 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	Waitlist Control Condition n=37 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	0.253 units on a scale Standard Error 0.112	0.423 units on a scale Standard Error 0.122	-0.013 units on a scale Standard Error 0.108

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation Group n=31 Participants 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	Healthy Eating Group n=34 Participants 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	Mediation + Healthy Eating Group n=31 Participants 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	Waitlist Control Condition n=37 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	-0.044 units on a scale Standard Error .16	-0.339 units on a scale Standard Error .168	-0.135 units on a scale Standard Error .154

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Meditation Group n=30 Participants 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	Healthy Eating Group n=33 Participants 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	Mediation + Healthy Eating Group n=29 Participants 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	Waitlist Control Condition n=37 Participants Waitlist control group participants will continue their normal activities and not add any form of mediation during the study period.
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	-5.939 units on a scale Standard Error 1.836	-7.483 units on a scale Standard Error 1.959	-4.378 units on a scale Standard Error 1.734

Adverse Events

Meditation Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Eating Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mediation + Healthy Eating Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rachel Radin

University of California San Francisco

Phone: 845-641-9569

Email: rachel.radin@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place