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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.
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!.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WW Only | Active Comparator | Participants will receive 3-month access to the WW digital program. |
|
| WW + PolyRules! | Experimental | Participants will receive 3-month access to the WW digital program and the PolyRules! app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WW Only | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah-Jeanne Salvy, PhD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Design Center | West Hollywood | California | 90069 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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WW Only included 13 participants who contributed baseline data. WW + PolyRules! included 17 participants who contributed baseline data, one participant in this group withdrew after providing baseline data but before completing the intervention and providing post-intervention data for a final analytic sample of 29.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 3 months |
|
Adverse event data was collected from the time of each participant's consent until the active intervention (12 weeks) and end of study procedures were completed, totaling 14-16 weeks.
N=34 enrolled, and n=3 withdrew prior to baseline. Participants are monitored for adverse events until they withdrew, were lost to follow up, or completed the study. WW Arm: n=13 monitored until end of study completion. WW + Poly! Arm: n=18 enrolled, and n=2 dropped out before study completion.
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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 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah-Jeanne Salvy | Cedars-Sinai Medical Center | 310-423-6423 | sarah.salvy@cshs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 15, 2022 | Aug 19, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| WW + PolyRules! | Behavioral | 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. |
|
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
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| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 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. | Not Posted | Jan 2025 | Baseline, 3 months | Participants |
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |