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Completed

NCT Number: NCT04747886

Inhibitory Control Adult Weight Management

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Design Center

West Hollywood, California, 90069, United States

About this study

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!.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. BMI at Three Months

    Time frame: 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 outcomes

  1. Correlation Between Dietary Logging Frequency and BMI Change.

    Time frame: 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.

  2. Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.

    Time frame: 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.

  3. Mean Percentage of Days With Dietary Self-monitoring

    Time frame: 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.

  4. Completion Rate of Weight Self-monitoring

    Time frame: 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.

  5. Completion Rate of Inhibitory Control Training Sessions

    Time frame: 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.

  6. Participant Attrition Rate at Three Months

    Time frame: 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).

  7. Number of Participants Who Completed Timepoint Follow-ups

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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