Inhibitory Control and Pediatric Weight Management

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747548
• Other study ID #: STUDY00001223
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: August 19, 2022

Study information

• Verified date: September 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	University of California, Riverside

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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