Inhibitory Control Adult Weight Management

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: WW Only; Behavioral: WW + PolyRules!

• Registration Number: NCT04747886
• Lead Sponsor: Cedars-Sinai Medical Center

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!.

Study Timeline

• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-03-12
• Primary Completion: 2021-07-31
• Study Completion: 2022-06-04
• Results First Submitted: 2022-06-15
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Results First Posted: 2024-08-29
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WW Only	WW Only	Participants will receive 3-month access to the WW digital program.
WW + PolyRules!	WW + PolyRules!	Participants will receive 3-month access to the WW digital program and the PolyRules! app.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pacific Design Center; 🇺🇸 West Hollywood, California, United States