Inhibitory Control and Pediatric Weight Management

Not Applicable

Completed

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

• Registration Number: NCT04747548
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

The purpose of this pilot study is to explore the benefits of supplementing the Kurbo online program with a cognitive training game (PolyRules!) among youth ages 7-13 with overweight or obesity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-08-26
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Between 7-13 years old at time of enrollment
• Are able to read, write and speak English
• BMI%ile ≥ 85%ile

Exclusion Criteria

• Concurrently enrolled in another weight loss intervention, are currently taking anti-obesity medications, or are undergoing bariatric surgery
• Have type 1 or type 2 diabetes
• Have severe cognitive delays
• Have visual/hearing impairments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kurbo + PolyRules!	Kurbo + PolyRules!	Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app.
Kurbo Only	Kurbo Only	Participants will receive 1-month access to the Kurbo digital program.

Primary Outcome Measures

Name	Time	Method
Change in BMI from baseline to 3 months to yield effect size.	Baseline, 1 month	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 Kurbo online app. This data will be used to calculate change in BMI.

Secondary Outcome Measures

Name	Time	Method
Change in performance on the N-back task.	Baseline, 1 month	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.
Change in visuo-spatial working memory based on performance on the Corsi task.	Baseline, 1 month	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 outcome.
Improvement in self-reported diet based on adherence to dietary guidelines.	Baseline, 1 month	Diet quality will be assessed using participant's self-reported food intake through the Kurbo 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 and food/beverages with added sugars.
Improvement in self-reported physical activity based on adherence to physical activity guidelines.	Baseline, 1 month	Physical activity will be assessed using participant's self-reported physical activity levels through the Kurbo 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.
Change in performance on the countermanding task.	Baseline, 1 month	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.
Change in performance on the cancellation task.	Baseline, 1 month	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.
Change in performance on the letter-number task.	Baseline, 1 month	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.

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States