Trial Outcomes & Findings for Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program (NCT NCT04302389)
NCT ID: NCT04302389
Last Updated: 2025-08-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
153 participants
Primary outcome timeframe
6 months
Results posted on
2025-08-07
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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153
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Overall Study
COMPLETED
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141
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Overall Study
NOT COMPLETED
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12
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Arm Trial of a Multi-component Commercial Digital Weight Loss Program
Baseline characteristics by cohort
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Age, Continuous
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41.1 years
STANDARD_DEVIATION 13.8 • n=5 Participants
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Sex: Female, Male
Female
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107 Participants
n=5 Participants
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Sex: Female, Male
Male
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46 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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19 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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134 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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20 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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16 Participants
n=5 Participants
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Race (NIH/OMB)
White
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107 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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10 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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153 participants
n=5 Participants
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BMI
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31.77 kg/m^2
STANDARD_DEVIATION 5.02 • n=5 Participants
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PRIMARY outcome
Timeframe: 6 monthsPercent 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Percent of Days Diet Tracking Feature Was Used in App
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39.1 percent of days of tracking food
Standard Deviation 30.8
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PRIMARY outcome
Timeframe: 6 monthsPercent of participants who agree or strongly agree that the program made them feel healthier.
Outcome measures
| Measure |
Lifestyle Modification Program
n=140 Participants
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.
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Intervention Acceptability
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102 Participants
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PRIMARY outcome
Timeframe: Baseline to 3-monthsWeight was measured using a smart scale at baseline and at the three month assessment.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Percent Change in Weight From Baseline to 3 Months
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-8.19 Percent change
Standard Deviation 7.51
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PRIMARY outcome
Timeframe: Baseline to 6-monthsWeight 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Weight Change in Pounds From Baseline to 6 Months
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-9.72 weight change in pounds
Standard Deviation 10.78
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PRIMARY outcome
Timeframe: 6 monthsNumber 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Number of Days Physical Activity Tracking Feature Was Used in App
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106.37 days
Standard Deviation 73.22
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PRIMARY outcome
Timeframe: 6 monthsNumber of weekly workshops attended by participants during the program. During the 6-month intervention, there were a total of 24 weekly workshops.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Number of Weekly Virtual Workshops Attended
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9.68 number of weekly workshops attended
Standard Deviation 7.16
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PRIMARY outcome
Timeframe: 6 monthsNumber 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Number of Weekly Check Ins Attended
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11.91 number of weekly check-ins attended
Standard Deviation 7.63
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PRIMARY outcome
Timeframe: 6 monthsAll 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Number of Weeks Participants Engaged in the Private, Online Community
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6.03 number of weeks a participant engaged
Standard Deviation 7.03
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PRIMARY outcome
Timeframe: 3 monthsWeight 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Weight Change in Pounds From Baseline to 3 Months
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-8.19 weight in pounds
Standard Deviation 7.51
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PRIMARY outcome
Timeframe: 6 monthsWeight 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=153 Participants
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.
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Percent Weight Change From Baseline to 6 Months
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-5.05 percent weight change
Standard Deviation 5.59
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SECONDARY outcome
Timeframe: Baseline to 6-monthsAt 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=132 Participants
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.
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Change in Fruit Intake Score
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.18 scores on scale of 0-5
Standard Deviation .82
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Change in Physical Activity
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783.95 METs
Standard Deviation 3611.88
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Changes in Quality of Life
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6.63 score on scale of 0-100
Standard Deviation 11.51
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Changes in Sleep Quality
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-.56 score on a 0-21 scale
Standard Deviation 2.56
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Changes in Food Cravings
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-.42 mean scores on a scale
Standard Deviation .52
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Changes in Hunger
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-13.02 score on a 0-100 scale
Standard Deviation 22.23
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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Changes in Positive Behavioral Automaticity
|
.86 score on a scale of 1-7
Standard Deviation 1.09
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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|---|---|
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Changes in Self-Compassion
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.09 score on a scale from 1-5
Standard Deviation .56
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SECONDARY outcome
Timeframe: Baseline to 6-monthsChanges 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=141 Participants
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.
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|---|---|
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Change in Well-being
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5.96 score on a 0-100 scale
Standard Deviation 15.36
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SECONDARY outcome
Timeframe: baseline to 6 monthsAt 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=132 Participants
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.
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|---|---|
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Change in Vegetable Intake Score
|
.16 scores on scale of 0-5
Standard Deviation .7
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SECONDARY outcome
Timeframe: baseline and 6 monthsAt 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.
Outcome measures
| Measure |
Lifestyle Modification Program
n=132 Participants
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.
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|---|---|
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Change in Salad Intake Score
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.18 scores on scale of 0-5
Standard Deviation .53
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Adverse Events
Lifestyle Modification Program
Serious events: 13 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lifestyle Modification Program
n=153 participants at risk
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.
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|---|---|
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Cardiac disorders
heart attack
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
broken leg
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
multiple sclerosis flare up
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Gastrointestinal disorders
diverticulitis
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Reproductive system and breast disorders
hysterectomy
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Blood and lymphatic system disorders
sarcoidosis
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Blood and lymphatic system disorders
Sarcoidosis flare up
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Musculoskeletal and connective tissue disorders
tardive dyskinesia
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
thyroid cancer
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Gastrointestinal disorders
eosinophilic gastrointestinal disease (EGID)
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
|
Reproductive system and breast disorders
tubal ligation
|
0.65%
1/153 • Number of events 1 • 6 months
The definition does not differ.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place