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!.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
34
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).
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.
Pacific Design Center
West Hollywood, California, United States
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
Correlation Between Dietary Logging Frequency and BMI Change.
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.
Time frame: From randomization to the end of treatment at 12 weeks
Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.
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.
Time frame: From baseline to end of treatment at 12 weeks.
Mean Percentage of Days With Dietary Self-monitoring
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.
Time frame: From baseline to end of treatment at 12 weeks.
Completion Rate of Weight Self-monitoring
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.
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Time frame: From baseline to end of treatment at 12 weeks
Completion Rate of Inhibitory Control Training Sessions
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.
Time frame: From baseline to end of treatment at 12 weeks
Participant Attrition Rate at Three Months
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).
Time frame: From enrollment to end of treatment at 12 weeks
Number of Participants Who Completed Timepoint Follow-ups
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.
Time frame: From Baseline to 12 Weeks