Inhibitory Control Adult Weight Management

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: WW Only; Behavioral: WW + PolyRules!

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!.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • West Hollywood, California, United States, 90069
      • Pacific Design Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WW Only; Participants will receive 3-month access to the WW digital program.	Behavioral: 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).
Experimental: WW + PolyRules!; Participants will receive 3-month access to the WW digital program and the PolyRules! app.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
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
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 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 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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Sarah-Jeanne Salvy, PhD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): June 4, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: STUDY00001164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No