Overweight and ObesityNCT04747548
Inhibitory Control and Pediatric Weight Management
A study testing Kurbo Only and Kurbo + PolyRules! in people with Overweight and Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Kurbo Only and Kurbo + PolyRules!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2021to 19 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 7-13 years old at time of enrollment
- Are able to read, write and speak English
- BMI%ile ≥ 85%ile
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90069
About this study
Official title: 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.
- Conditions
- Overweight and Obesity
- Being tested
- Kurbo Only, Kurbo + PolyRules!
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kurbo OnlyBehavioural
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!Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Kurbo Only | Active comparator | Participants will receive 1-month access to the Kurbo digital program. Receives: Behavioral: Kurbo Only |
| Kurbo + PolyRules! | Experimental | Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app. Receives: Behavioral: Kurbo + PolyRules! |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start26 Aug 2021
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Riverside
- Responsible party
- Principal investigator, Sarah Salvy, Cedars-Sinai Medical Center
- Investigators
- Sarah-Jeanne Salvy, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747548
- Sponsor's protocol ID
- STUDY00001223
- Status last verified
- Sep 2022
- First submitted
- 5 Feb 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training in Youth: A Pilot Study
- ClinicalTrials.gov ID
- NCT04747548
- Acronym / sponsor ID
- STUDY00001223
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Riverside
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kurbo Only | Active comparator | Behavioral: Kurbo OnlyParticipants will receive 1-month access to the Kurbo digital program. |
| Kurbo + PolyRules! | Experimental | Behavioral: Kurbo + PolyRules!Participants will receive 1-month access to the Kurbo digital program and the PolyRules! app. |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 7-13 years old at time of enrollment
- Are able to read, write and speak English
- BMI%ile ≥ 85%ile
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kurbo OnlyKurbo 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. | Behavioural | Kurbo Only |
| 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. | Behavioural | Kurbo + PolyRules! |
Primary outcome
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.
7 secondary outcomes
Improvement in self-reported diet based on adherence to dietary guidelines.
Time frame: Baseline, 1 month
Improvement in self-reported physical activity based on adherence to physical activity guidelines.
Time frame: Baseline, 1 month
Change in performance on the cancellation task.
Time frame: Baseline, 1 month
Change in performance on the countermanding task.
Time frame: Baseline, 1 month
Change in performance on the N-back task.
Time frame: Baseline, 1 month
Change in performance on the letter-number task.
Time frame: Baseline, 1 month
Change in visuo-spatial working memory based on performance on the Corsi task.
Time frame: Baseline, 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah-Jeanne Salvy, PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kurbo Only and Kurbo + PolyRules! in people with Overweight and Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BMI from baseline to 3 months to yield effect size. (time frame: Baseline, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.