Inhibitory Control and Pediatric Weight Management

NCT04747548 | Completed

• 1 other identifier: STUDY00001223
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Improvement in self-reported diet based on adherence to dietary guidelines.

  Baseline, 1 month

• Improvement in self-reported physical activity based on adherence to physical activity guidelines.

  Baseline, 1 month

• Change in performance on the cancellation task.

  Baseline, 1 month

• Change in performance on the countermanding task.

  Baseline, 1 month

• Change in performance on the N-back task.

  Baseline, 1 month

Study Arms (2)

Kurbo Only

ACTIVE COMPARATOR

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

Behavioral: Kurbo Only

Kurbo + PolyRules!

EXPERIMENTAL

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

Behavioral: Kurbo + PolyRules!

Interventions

Kurbo Only BEHAVIORAL

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 Only

Kurbo + PolyRules! BEHAVIORAL

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.

Kurbo + PolyRules!

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• University of California, Riverside: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah-Jeanne Salvy, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Medicine

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: August 26, 2021
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)