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| Name | Class |
|---|---|
| WW International Inc | INDUSTRY |
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The goal of the proposed research project is to evaluate the acceptability and efficacy of an online multicomponent commercial weight loss program and to understand the relationship between program engagement and weight loss and health outcomes.
Technology is changing the opportunities to deliver behavioral weight loss programs and providing a way to extend their reach to wider audiences. Commercial programs that were once completely delivered via in person meetings at brick-and-mortar businesses are now expanding to virtual programs. WW (formerly known as Weight Watchers) is an industry leader and one of few commercial programs that has significant evidence for efficacy on weight loss. Their program currently includes a mobile app - that helps people follow the WW Program, rewards for consistent tracking and achieving milestones, an online community to connect with other users, and a 24/7 text chat with coaches.
Previous research by the investigators and others reveals that greater engagement in an online group-based weight loss program is associated with greater weight loss. We have found that an online group coaching program paired with a calorie tracking mobile app is effective at producing weight loss. WW is testing a new comprehensive program that involves an updated program paired with virtual workshops that offer actionable behavior change techniques for members, led by a trained WW coach. They have agreed to fund us to perform a one-arm trial of their new comprehensive program that includes a holistic approach to healthy lifestyle (activity, diet, and mindset). Findings will inform the continued development of this program. Our aims are as follows: 1) To examine the preliminary outcomes and acceptability of a multicomponent online commercial weight loss program that includes a mobile app, incentives for tracking, weekly virtual workshops, and an online community. Preliminary outcome is defined as weight change from baseline to 3 and 6-months. Secondary preliminary outcomes include changes in diet quality, physical activity, quality of life, sleep quality, and food cravings from baseline to 6 months. Acceptability of each program component and the overall program will be evaluated at 6 months. 2) To examine whether greater app use, greater engagement in the online community, and engagement with a higher number of peers (in the online community) predict greater weight loss at 3- and 6-months. 3) To examine the associations between total use of program components (and each individual program component) and change in weight. We hypothesize that greater use of program components (individually and total) will predict greater weight loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Modification Program | Experimental | This 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myWW App, Virtual Workshops, and Private Facebook Group | Behavioral | The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals each week. Participants will be encouraged to participate in a private Facebook group that gives participants an opportunity to receive motivational support from each other. Participants can post about their journey through photos, videos, and comments. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Days Diet Tracking Feature Was Used in App | Percent of days participants used the diet tracking feature in the WW app during the intervention to track their daily food intake. A day of use will be defined as a day where participants tracked any food item in the WW app. | 6 months |
| Intervention Acceptability | Percent of participants who agree or strongly agree that the program made them feel healthier. | 6 months |
| Percent Change in Weight From Baseline to 3 Months | Weight was measured using a smart scale at baseline and at the three month assessment. | Baseline to 3-months |
| Weight Change in Pounds From Baseline to 6 Months | Weight will be measured using a smart scale at all assessments. Weight change will be calculated as weight at 6 months in pounds minus baseline weight in pounds. Lower values mean more weight loss. | Baseline to 6-months |
| Number of Days Physical Activity Tracking Feature Was Used in App | Number of days participants used the physical activity feature in the WW app during the intervention. A day of use will be defined as any day in which any physical activity was logged. Total days possible = 168 days. | 6 months |
| Number of Weekly Virtual Workshops Attended | Number of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fruit Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruit intake. 1 assessed fruit intake. Change in fruit intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in fruit intake. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry Pagoto, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37271576 | Derived | Xu R, Bannor R, Cardel MI, Foster GD, Pagoto S. How much food tracking during a digital weight-management program is enough to produce clinically significant weight loss? Obesity (Silver Spring). 2023 Jul;31(7):1779-1786. doi: 10.1002/oby.23795. Epub 2023 Jun 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Modification Program | This 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research. myWW App, Virtual Workshops, and Private Facebook Group: The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Modification Program | This 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research. myWW App, Virtual Workshops, and Private Facebook Group: The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent of Days Diet Tracking Feature Was Used in App | Percent of days participants used the diet tracking feature in the WW app during the intervention to track their daily food intake. A day of use will be defined as a day where participants tracked any food item in the WW app. | Posted | Mean | Standard Deviation | percent of days of tracking food | 6 months |
|
6 months
The definition does 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 | Lifestyle Modification Program | This 6-month intervention includes the use of three components: WW's mobile app, virtual workshops, and a private online community. The WW Program involves: self-monitoring of weight, dietary intake, and physical activity; making dietary changes; increasing physical activity; shifting to a more helpful mindset; and learning behavioral strategies to manage these goals. Each week, participants will set goals and weigh-in with a coach via virtual workshop. Participants will be encouraged to use the app and private online community daily and attend weekly virtual workshops. The weekly virtual workshop led by a trained WW Coach features a behavior change technique and enables the participant to practice it to support their goals. These are actionable techniques and strategies that are grounded in scientific research. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart attack | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Participant reported via email on 3/30 that she was admitted to the hospital due to having a heart attack. We received the email morning of 3/31. This happened prior to the start date of the study. Stents were placed in 2 vessels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sherry Pagoto | University of Connecticut | 860-486-8979 | sherry.pagoto@uconn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2021 | Nov 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2021 | Nov 15, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 11, 2021 | Nov 15, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This project includes a one-arm trial to evaluate WW's new lifestyle modification program.
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|
| Number of Weekly Check Ins Attended | Number of weekly check ins completed by participants during the program. During the 6-month intervention, there were 24 opportunities for weekly check ins. Higher numbers mean more weekly check ins were completed. | 6 months |
| Number of Weeks Participants Engaged in the Private, Online Community | All posts, comments, and reactions made in the Facebook group were captured using Grytics for Facebook each of the 24 weeks of the intervention. Participants were considered engaged with the intervention by making at least one post, one comment, and/or one reaction (e.g., like) during the intervention week. Values could range from 0 to 24 weeks with higher numbers indicating more frequent engagement in the intervention. | 6 months |
| Weight Change in Pounds From Baseline to 3 Months | Weight will be assessed via digital scales provided to participants. Weight change will be calculated by subtracting weight in pounds at 3 months from baseline weight. Lower values indicate greater weight loss in pounds. | 3 months |
| Percent Weight Change From Baseline to 6 Months | Weight is assessed via digital scales provided to participants. Percent weight change will be calculated by subtracting 6 month weight in pounds from baseline weight in pounds, dividing by baseline weight in pounds, and then multiplying this number by 100. Lower values indicated greater weight loss. | 6 months |
| Baseline to 6-months |
| Change in Physical Activity | Changes in physical activity will be measured from baseline to 6-months using the Global Physical Activity Questionnaire (GPAQ). The GPAQ has questions assessing activity at work, travel to and from places, and recreational activities. The number of minutes spent on each activity is assigned a METs value to determine level of energy expenditure. The higher the METs value the higher the activity level. | Baseline to 6-months |
| Changes in Quality of Life | Changes in weight related quality of life will be measured from baseline to 6-months using the Impact of Weight on Quality of Life-Lite. This is a 31-item measure assessing physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Scores range from 0-100, with 100 representing the best quality of life. Change was calculated by subtracting 6 month scores from baseline scores. Higher values indicate greater increases in quality of life. | Baseline to 6-months |
| Changes in Sleep Quality | Changes in sleep quality will be measured from baseline to 6-months using the Pittsburgh Sleep Quality Index. This measure contains 10 items to assess sleep quality with a score possible score of 0 - 21. Lower scores represent better the sleep quality (< 5 is associated with good sleep quality; > 5 is associated with poor sleep quality. Change in sleep quality was calculated by subtracting 6 month scores from baseline scores. Lower values indicate improvements in sleep quality. | Baseline to 6-months |
| Changes in Food Cravings | Changes in food cravings will be measured from baseline to 6-months using the Food Craving Inventory. This inventory includes 28 foods that are scored based on level of craving ranging in answers from 1 (Never) to 5 (Always) for each. A mean is calculated across the 28 items. Scores then would range from a minimum of 1 to a maximum of 5. Higher scores indicate more frequent cravings. Change was calculated by subtracting 6 month scores from baseline scores. Higher scores indicate greater increases in food cravings. | Baseline to 6-months |
| Changes in Hunger | Changes in hunger will be measured from baseline to 6-months using the Hunger VAS (Visual Analogue Scale). This one-question measure asks "How hungry did you feel over the past week" and is composed of a slider with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants rated their hunger over the past week using a slider on a visual analog scale ranging from 0=not at all hungry to 100=extremely hungry. Change in hunger was then calculated by subtracting the hunger score at 6 months from the hunger score at baseline. Higher values indicate increases in hunger over time and lower values indicate decreases in hunger over time. | Baseline to 6-months |
| Changes in Positive Behavioral Automaticity | Changes in behavioral automaticity will be measured using the Self-Report Behavioral Automaticity Index (SRBAI). This 4-item measure assesses whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree. A mean score was calculated for each behavior. Then, mean scores were calculated for the 7 healthy behaviors to produce a positive behavioral automaticity score which could range from 1 to 7. Change in positive behavioral automaticity was then calculated by subtracting the 6 month value from the baseline value. Higher scores indicate greater behavioral automaticity for healthy behaviors. | Baseline to 6-months |
| Changes in Self-Compassion | Changes in self-compassion will be measured using the Self-Compassion Scale. This is a 26-item measure of self-compassion that consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Items were rated a scale ranging from 1=almost never to 5=almost always. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means. The total possible scores range from 1-5. Then to calculate change in self-compassion, we subtracted the 6 month value from the baseline value. Higher scores mean greater increases in self-compassion over time. | Baseline to 6-months |
| Change in Well-being | Changes in well-being will be measured using the WHO-5 Well Being Index (0-100 score where higher scores mean greater well-being). Change in well-being was then calculated by subtracting the 6 month score from the baseline score. Higher values indicate increases in well-being over time. | Baseline to 6-months |
| Change in Vegetable Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed vegetable intake. Change in vegetable intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in vegetable intake. | baseline to 6 months |
| Change in Salad Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed salad intake. Change in salad intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in salad intake. | baseline and 6 months |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
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| Primary | Intervention Acceptability | Percent of participants who agree or strongly agree that the program made them feel healthier. | Posted | Count of Participants | Participants | 6 months |
|
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| Primary | Percent Change in Weight From Baseline to 3 Months | Weight was measured using a smart scale at baseline and at the three month assessment. | Posted | Mean | Standard Deviation | Percent change | Baseline to 3-months |
|
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|
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| Primary | Weight Change in Pounds From Baseline to 6 Months | Weight will be measured using a smart scale at all assessments. Weight change will be calculated as weight at 6 months in pounds minus baseline weight in pounds. Lower values mean more weight loss. | Posted | Mean | Standard Deviation | weight change in pounds | Baseline to 6-months |
|
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| Primary | Number of Days Physical Activity Tracking Feature Was Used in App | Number of days participants used the physical activity feature in the WW app during the intervention. A day of use will be defined as any day in which any physical activity was logged. Total days possible = 168 days. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
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| Primary | Number of Weekly Virtual Workshops Attended | Number of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops. | Posted | Mean | Standard Deviation | number of weekly workshops attended | 6 months |
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| Primary | Number of Weekly Check Ins Attended | Number of weekly check ins completed by participants during the program. During the 6-month intervention, there were 24 opportunities for weekly check ins. Higher numbers mean more weekly check ins were completed. | Posted | Mean | Standard Deviation | number of weekly check-ins attended | 6 months |
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| Primary | Number of Weeks Participants Engaged in the Private, Online Community | All posts, comments, and reactions made in the Facebook group were captured using Grytics for Facebook each of the 24 weeks of the intervention. Participants were considered engaged with the intervention by making at least one post, one comment, and/or one reaction (e.g., like) during the intervention week. Values could range from 0 to 24 weeks with higher numbers indicating more frequent engagement in the intervention. | Posted | Mean | Standard Deviation | number of weeks a participant engaged | 6 months |
|
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| Primary | Weight Change in Pounds From Baseline to 3 Months | Weight will be assessed via digital scales provided to participants. Weight change will be calculated by subtracting weight in pounds at 3 months from baseline weight. Lower values indicate greater weight loss in pounds. | Posted | Mean | Standard Deviation | weight in pounds | 3 months |
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| Primary | Percent Weight Change From Baseline to 6 Months | Weight is assessed via digital scales provided to participants. Percent weight change will be calculated by subtracting 6 month weight in pounds from baseline weight in pounds, dividing by baseline weight in pounds, and then multiplying this number by 100. Lower values indicated greater weight loss. | Posted | Mean | Standard Deviation | percent weight change | 6 months |
|
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| Secondary | Change in Fruit Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruit intake. 1 assessed fruit intake. Change in fruit intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in fruit intake. | Posted | Mean | Standard Deviation | scores on scale of 0-5 | Baseline to 6-months |
|
|
|
| Secondary | Change in Physical Activity | Changes in physical activity will be measured from baseline to 6-months using the Global Physical Activity Questionnaire (GPAQ). The GPAQ has questions assessing activity at work, travel to and from places, and recreational activities. The number of minutes spent on each activity is assigned a METs value to determine level of energy expenditure. The higher the METs value the higher the activity level. | Posted | Mean | Standard Deviation | METs | Baseline to 6-months |
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| Secondary | Changes in Quality of Life | Changes in weight related quality of life will be measured from baseline to 6-months using the Impact of Weight on Quality of Life-Lite. This is a 31-item measure assessing physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Scores range from 0-100, with 100 representing the best quality of life. Change was calculated by subtracting 6 month scores from baseline scores. Higher values indicate greater increases in quality of life. | Posted | Mean | Standard Deviation | score on scale of 0-100 | Baseline to 6-months |
|
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| Secondary | Changes in Sleep Quality | Changes in sleep quality will be measured from baseline to 6-months using the Pittsburgh Sleep Quality Index. This measure contains 10 items to assess sleep quality with a score possible score of 0 - 21. Lower scores represent better the sleep quality (< 5 is associated with good sleep quality; > 5 is associated with poor sleep quality. Change in sleep quality was calculated by subtracting 6 month scores from baseline scores. Lower values indicate improvements in sleep quality. | Posted | Mean | Standard Deviation | score on a 0-21 scale | Baseline to 6-months |
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| Secondary | Changes in Food Cravings | Changes in food cravings will be measured from baseline to 6-months using the Food Craving Inventory. This inventory includes 28 foods that are scored based on level of craving ranging in answers from 1 (Never) to 5 (Always) for each. A mean is calculated across the 28 items. Scores then would range from a minimum of 1 to a maximum of 5. Higher scores indicate more frequent cravings. Change was calculated by subtracting 6 month scores from baseline scores. Higher scores indicate greater increases in food cravings. | Posted | Mean | Standard Deviation | mean scores on a scale | Baseline to 6-months |
|
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| Secondary | Changes in Hunger | Changes in hunger will be measured from baseline to 6-months using the Hunger VAS (Visual Analogue Scale). This one-question measure asks "How hungry did you feel over the past week" and is composed of a slider with words anchored at each end describing the extremes (Not at all hungry, Extremely hungry). Participants rated their hunger over the past week using a slider on a visual analog scale ranging from 0=not at all hungry to 100=extremely hungry. Change in hunger was then calculated by subtracting the hunger score at 6 months from the hunger score at baseline. Higher values indicate increases in hunger over time and lower values indicate decreases in hunger over time. | Posted | Mean | Standard Deviation | score on a 0-100 scale | Baseline to 6-months |
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| Secondary | Changes in Positive Behavioral Automaticity | Changes in behavioral automaticity will be measured using the Self-Report Behavioral Automaticity Index (SRBAI). This 4-item measure assesses whether Behavior X is something... "I do automatically", "I do without having to consciously remember", "I do without thinking", and "I start doing before I realize I'm doing it". Items are scored using a 7-point Likert scale ranging from strongly disagree to strongly agree. A mean score was calculated for each behavior. Then, mean scores were calculated for the 7 healthy behaviors to produce a positive behavioral automaticity score which could range from 1 to 7. Change in positive behavioral automaticity was then calculated by subtracting the 6 month value from the baseline value. Higher scores indicate greater behavioral automaticity for healthy behaviors. | Posted | Mean | Standard Deviation | score on a scale of 1-7 | Baseline to 6-months |
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| Secondary | Changes in Self-Compassion | Changes in self-compassion will be measured using the Self-Compassion Scale. This is a 26-item measure of self-compassion that consists of six subscales: self-kindness, self-judgement, common humanity, isolation, mindfulness, and over-identified. Items were rated a scale ranging from 1=almost never to 5=almost always. Subscales are computed by calculating the mean of subscale item responses. A total self-compassion score can be obtained by reverse scoring the negative subscale items (self-judgement, isolation, and over-identification) and computing a grand mean of all six subscale means. The total possible scores range from 1-5. Then to calculate change in self-compassion, we subtracted the 6 month value from the baseline value. Higher scores mean greater increases in self-compassion over time. | Posted | Mean | Standard Deviation | score on a scale from 1-5 | Baseline to 6-months |
|
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| Secondary | Change in Well-being | Changes in well-being will be measured using the WHO-5 Well Being Index (0-100 score where higher scores mean greater well-being). Change in well-being was then calculated by subtracting the 6 month score from the baseline score. Higher values indicate increases in well-being over time. | Posted | Mean | Standard Deviation | score on a 0-100 scale | Baseline to 6-months |
|
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| Secondary | Change in Vegetable Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed vegetable intake. Change in vegetable intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in vegetable intake. | Posted | Mean | Standard Deviation | scores on scale of 0-5 | baseline to 6 months |
|
|
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| Secondary | Change in Salad Intake Score | At baseline and 6 months, participants completed the National Health Interview Survey Five-Factor Screener, which contains 19 items that assess the consumption frequency (measured on a scale ranging from 0=never to 5=≥5 times per day) of different food groups, including fruits and vegetables. 1 assessed salad intake. Change in salad intake score was calculated by subtracting 6 month values from baseline values. Higher change scores indicate greater increases in salad intake. | Posted | Mean | Standard Deviation | scores on scale of 0-5 | baseline and 6 months |
|
|
|
| 0 |
| 153 |
| 13 |
| 153 |
| 0 |
| 153 |
|
| broken leg | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Participant broke leg in a motorcycle accident and was admitted to the hospital and had surgery to insert a pin to support the bone. Participant was casted and referred to physical therapy. |
|
| multiple sclerosis flare up | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Participant reported nerve pain in the face (trigeminal neuralgia) and went to a neurologist for care. Treatment involved medication. |
|
| diverticulitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Participant reported a diagnosis of diverticulitis on the AE form. Participant went to doctor and was put on antibiotics. |
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| Hernia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Participant indicated on the AE form that they had hernia surgery. |
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| Fall | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Participant indicated that they fell off of a cliff while hiking on vacation. They were taken to the hospital and had soft tissue injuries and lacerations treated. |
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| hysterectomy | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment | Participant stated on AE form that they had an emergency outpatient hysterectomy. They were on bedrest for 2 weeks during recovery. |
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| sarcoidosis | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | Participant indicated on AE form that they discovered swollen lymph nodes and were diagnosed with sarcoidosis. They received a lymph node biopsy and were put on hydroxychloroquine. |
|
| Sarcoidosis flare up | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment | Participant indicated on the 6 month survey they had a sarcoidosis flare up that affected their energy level. They were under their physician's care. |
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| tardive dyskinesia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Participant indicated on the 3 month survey that due to the medication they were taking they were diagnosed with tardive dyskinesia. |
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| thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment | Participant said they noticed their neck was slightly enlarged. They went to their doctor and was given a biopsy and a lobectomy which revealed stage 1 papillary thyroid cancer. The rest of the thyroid was removed. They are now cancer free. |
|
| eosinophilic gastrointestinal disease (EGID) | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Participant withdrew from the study after being diagnosed with EGID. Their doctor referred them to dietary counseling. |
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| tubal ligation | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment | Participant had an IUD embedded and had to have it surgically removed along with receiving a tubal ligation. |
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