Overweight and Obesity
Conditions
Brief summary
The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with overweight or obesity.
Detailed description
This two-arm pilot study will be used to estimate the effect size in weight loss of supplementing the WW (formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) among adults with overweight or obesity. Participants ages 18 and older (n=30) will be randomly assigned to one of two study arms: (1) WW (formerly Weight Watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All participants will complete demographic, medical history questionnaires and cognitive assessment battery at baseline/enrollment and after completing the 3-month intervention protocol. All interactions with PolyRules! and WW will be passively recorded to monitor the frequency of interaction with WW and PolyRules!.
Interventions
BEHAVIORALWW Only
WW is a structured behavioral weight management program that focuses on diet, physical activity and mindset skills. The dietary approach is based on creating an energy deficit diet to produce weight loss while also being attentive to the quality of the calories. Specifically, the WW program assigns SmartPoints values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, non-fat yogurt, fish).
BEHAVIORALWW + PolyRules!
In addition to WW, participants will be asked to engage in daily cognitive training using the PolyRules! app for three months. They will be instructed to start with 20-min of daily cognitive training and to progressively increase their training time to 30-min.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Read, write and speak English with acceptable visual acuity * BMI between 25-40 kg/m\^2
Exclusion criteria
* Currently enrolled in weight loss interventions or undergoing bariatric surgery * Pregnant women * Individuals with severe cognitive delays or visual/hearing impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI at Three Months | Baseline, 3 months | BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline and at 3 months. Throughout the study, participants will be asked to self-report their weight through the WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between Dietary Logging Frequency and BMI Change. | From randomization to the end of treatment at 12 weeks | The statistical association between the cumulative number of days food logs were submitted and the change in Body Mass Index (BMI). This will be analyzed using a Pearson correlation coefficient to determine the strength and direction of the relationship. |
| Correlation Between Completed Inhibitory Control Training Sessions and BMI Change. | From baseline to end of treatment at 12 weeks. | The statistical association between the cumulative number of days inhibitory control training sessions were completed and the change in Body Mass Index (BMI). This will be analyzed using a Pearson correlation coefficient to determine the strength and direction of the relationship. |
| Mean Percentage of Days With Dietary Self-monitoring | From baseline to end of treatment at 12 weeks. | Dietary self-monitoring adherence was calculated for each participant as the percentage of days they recorded a food log out of the total days in the 12-week intervention period (84 days total). This measure reports the mean percentage across all participants within each group. |
| Completion Rate of Weight Self-monitoring | From baseline to end of treatment at 12 weeks | Completion rate of weight self-monitoring is defined as the frequency of weekly body weight entries recorded. The outcome is calculated as the percentage of entries with a recorded weight out of the total number of weeks in the 12-week intervention period. |
| Completion Rate of Inhibitory Control Training Sessions | From baseline to end of treatment at 12 weeks | Completion rate of the inhibitory control training protocol is calculated as the proportion of prescribed Inhibitory Control Training sessions successfully completed by the participant. The protocol prescribes a total of 60 30-minute training sessions over the 12-week intervention period. Adherence for each participant is calculated as the number of completed sessions divided by the total number of prescribed sessions. |
| Participant Attrition Rate at Three Months | From enrollment to end of treatment at 12 weeks | Participant attrition rate is defined as the proportion of randomized participants who prematurely withdrew from the study prior to completing the final 12-week assessment. Withdrawal is defined as a participant's explicit statement of intent to discontinue the intervention and/or the remaining study assessments after randomization. This is calculated as the total number of participants who withdrew divided by the total number of participants randomized (N=30). |
| Number of Participants Who Completed Timepoint Follow-ups | From Baseline to 12 Weeks | This measure assesses retention and study feasibility by counting the total number of randomized participants who successfully completed the primary cognitive assessment at the 12-week post-randomization timepoint (N=30). Completion is defined as the successful administration and completion of the cognitive battery. Participants who withdrew consent or were lost to follow-up post-randomization are counted as non-completers. Participants who withdrew prior to randomization are excluded from this count. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah-Jeanne Salvy, PhD
Cedars-Sinai Medical Center
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| WW Only Participants will receive 3-month access to the WW digital program.
WW Only: WW is a structured behavioral weight management program that focuses on diet, physical activity and mindset skills. The dietary approach is based on creating an energy deficit diet to produce weight loss while also being attentive to the quality of the calories. Specifically, the WW program assigns SmartPoints values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, non-fat yogurt, fish). | 13 |
| WW + PolyRules! Participants will receive 3-month access to the WW digital program and the PolyRules! app.
WW + PolyRules!: In addition to WW, participants will be asked to engage in daily cognitive training using the PolyRules! app for three months. They will be instructed to start with 20-min of daily cognitive training and to progressively increase their training time to 30-min. | 17 |
| Total | 30 |
Baseline characteristics
| Characteristic | WW Only | WW + PolyRules! | Total |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 10 | 51.9 years STANDARD_DEVIATION 13.4 | 49.5 years STANDARD_DEVIATION 12.14 |
| BMI | 35.1 kg/m^2 STANDARD_DEVIATION 6.6 | 35.3 kg/m^2 STANDARD_DEVIATION 6.3 | 35.2 kg/m^2 STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 14 Participants | 23 Participants |
| Region of Enrollment United States | 13 participants | 17 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 26 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 18 |
| other Total, other adverse events | 0 / 13 | 0 / 18 |
| serious Total, serious adverse events | 0 / 13 | 0 / 18 |
Outcome results
Primary
BMI at Three Months
BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline and at 3 months. Throughout the study, participants will be asked to self-report their weight through the WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| WW Only | BMI at Three Months | 34.53 kg/m^2 | Standard Deviation 6.5 |
| WW + PolyRules! | BMI at Three Months | 34.43 kg/m^2 | Standard Deviation 6.2 |
Other Pre-specified
Change in Performance on the Cancellation Task.
Attention and inhibitory control will be assessed using participant's change in performance on the cancellation task. Performance will be measured by summing up the total number of errors committed within a specific time frame, such that lower scores are more favorable.
Time frame: Baseline, 3 months
Other Pre-specified
Change in Performance on the Countermanding Task.
Attention and inhibitory control will also be assessed using participant's change in performance on the countermanding task. Performance will be measured by summing the number of accurate responses within a 15 second timeframe, such that higher scores are more favorable.
Time frame: Baseline, 3 months
Other Pre-specified
Change in Performance on the Letter-number Task.
Change in working memory will also be assessed using participant's performance on the letter-number task. Performance will be measured by looking at error rates, such that higher error rates are worse outcomes.
Time frame: Baseline, 3 months
Other Pre-specified
Change in Performance on the N-back Task.
Change in working memory will be assessed using participant's performance on the N-back task. Performance will be measured by looking at the number of errors such that more errors is a worse outcome.
Time frame: Baseline, 3 months
Other Pre-specified
Change in Visuo-spatial Working Memory Based on Performance on the Corsi Task.
Change in visuo-spatial working memory will be assessed by participant's performance on the Corsi tasks. Performance will be measured by assessing the number of correct sequences, such that a larger number of correct sequences is a more favorable outcomes.
Time frame: Baseline, 3 months
Other Pre-specified
To Explore Whether Inhibitory Control Training Confers Any Benefits in Self-reported Diet
Diet quality will be assessed using participant's self-reported food intake through the WW (formerly Weight Watchers) online app. This data will be leveraged to assess changes in adherence to dietary guidelines for fruits and vegetables, servings of whole grains, red/processed meats, alcoholic beverages and food/beverages with added sugars.
Time frame: Baseline, 3 months
Other Pre-specified
To Explore Whether Inhibitory Control Training Confers Any Increases in Self-reported Physical Activity.
Physical activity will be assessed using participant's self-reported physical activity levels through the WW (formerly Weight Watchers) online app. This data will be leveraged to assess changes in engagement in energy balance behaviors by capturing information on the type, duration and intensity of activity.
Time frame: Baseline, 3 months