Inhibitory Control and Pediatric Weight Management

Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training in Youth: A Pilot Study

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90069
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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: Kurbo Only; Participants will receive 1-month access to the Kurbo digital program.	Behavioral: Kurbo Only; Kurbo is a structured behavioral weight management program for youth that focuses on diet, physical activity and mindset skills and is based on the traffic light diet developed at Stanford University. 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 consumed. Foods are categorized into the colors of a traffic light signal based on their nutritional and caloric content, such that youth are encouraged to eat more of green and yellow foods, and less of red foods. Participants will log their daily food intake and self-monitor dietary and physical activity behaviors, incorporating behavior substitution and habit formation. Participants will also have 15 minute weekly individualized coaching sessions.
Experimental: Kurbo + PolyRules!; Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app.	Behavioral: Kurbo + PolyRules!; In addition to Kurbo, 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
Change in BMI from baseline to 3 months to yield effect size.	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.	Baseline, 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in self-reported diet based on adherence to dietary guidelines.	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.	Baseline, 1 month
Improvement in self-reported physical activity based on adherence to physical activity guidelines.	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.	Baseline, 1 month
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, 1 month
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, 1 month
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, 1 month
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, 1 month
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 outcome.	Baseline, 1 month

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: University of California, Riverside

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Actual): August 19, 2022
• Study Completion (Actual): August 19, 2022

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: STUDY00001223

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