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Inhibitory Control and Pediatric Weight Management

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kurbo Only
Kurbo + PolyRules!
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

7 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Kurbo Only

Kurbo + PolyRules!

Arm Description

Participants will receive 1-month access to the Kurbo digital program.

Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 5, 2021
Last Updated
September 15, 2022
Sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Riverside
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1. Study Identification

Unique Protocol Identification Number
NCT04747548
Brief Title
Inhibitory Control and Pediatric Weight Management
Official Title
Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training in Youth: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
University of California, Riverside

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kurbo Only
Arm Type
Active Comparator
Arm Description
Participants will receive 1-month access to the Kurbo digital program.
Arm Title
Kurbo + PolyRules!
Arm Type
Experimental
Arm Description
Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app.
Intervention Type
Behavioral
Intervention Name(s)
Kurbo Only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kurbo + PolyRules!
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMI from baseline to 3 months to yield effect size.
Description
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.
Time Frame
Baseline, 1 month
Secondary Outcome Measure Information:
Title
Improvement in self-reported diet based on adherence to dietary guidelines.
Description
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.
Time Frame
Baseline, 1 month
Title
Improvement in self-reported physical activity based on adherence to physical activity guidelines.
Description
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.
Time Frame
Baseline, 1 month
Title
Change in performance on the cancellation task.
Description
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.
Time Frame
Baseline, 1 month
Title
Change in performance on the countermanding task.
Description
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.
Time Frame
Baseline, 1 month
Title
Change in performance on the N-back task.
Description
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.
Time Frame
Baseline, 1 month
Title
Change in performance on the letter-number task.
Description
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.
Time Frame
Baseline, 1 month
Title
Change in visuo-spatial working memory based on performance on the Corsi task.
Description
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.
Time Frame
Baseline, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah-Jeanne Salvy, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90069
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Inhibitory Control and Pediatric Weight Management

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