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Completed

NCT Number: NCT04747548

Inhibitory Control and Pediatric Weight Management

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.

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Key information

Conditions

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

Age range

7 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90069, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 + 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.

Primary outcomes

  1. Change in BMI from baseline to 3 months to yield effect size.

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Change in performance on the cancellation task.

    Time frame: 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.

  4. Change in performance on the countermanding task.

    Time frame: 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.

  5. Change in performance on the N-back task.

    Time frame: 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.

  6. Change in performance on the letter-number task.

    Time frame: 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.

  7. Change in visuo-spatial working memory based on performance on the Corsi task.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • University of California, Riverside

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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