Overweight and ObesityNCT04747886

Inhibitory Control Adult Weight Management

A study testing WW Only and WW + PolyRules! in people with Overweight and Obesity, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this pilot study is to explore the benefits of supplementing the WW (formerly Weight Watchers) online program with a cognitive training game (PolyRules!) among adults with overweight or obesity. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity
What is being tested?: WW Only and WW + PolyRules!
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 12 Mar 2021to 4 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years of age or older
Read, write and speak English with acceptable visual acuity
BMI between 25-40 kg/m^2

Who cannot join

Currently enrolled in weight loss interventions or undergoing bariatric surgery
Pregnant women
Individuals with severe cognitive delays or visual/hearing impairment

Trial locations and contacts

1 site in 1 country.

United States1 site

Pacific Design Center
West Hollywood, California, 90069

Other trials in United States

About this study

Official title: Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study

Read the detailed description

This two-arm pilot study will be used to estimate the effect size in weight loss of supplementing the WW (formerly Weight Watchers) online program with gamified inhibitory control training (PolyRules!) among adults with overweight or obesity. Participants ages 18 and older (n=30) will be randomly assigned to one of two study arms: (1) WW (formerly Weight Watchers) only or (2) WW + Gamified inhibitory control training (PolyRules!). All participants will complete demographic, medical history questionnaires and cognitive assessment battery at baseline/enrollment and after completing the 3-month intervention protocol. All interactions with PolyRules! and WW will be passively recorded to monitor the frequency of interaction with WW and PolyRules!.

Conditions: Overweight and Obesity
Being tested: WW Only, WW + 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.

WW OnlyBehavioural
WW is a structured behavioral weight management program that focuses on diet, physical activity and mindset skills. 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. Specifically, the WW program assigns SmartPoints values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, non-fat yogurt, fish).
WW + PolyRules!Behavioural
In addition to WW, 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 groups in NCT04747886
Study group	Role	What they receive
WW Only	Active comparator	Participants will receive 3-month access to the WW digital program. Receives: Behavioral: WW Only
WW + PolyRules!	Experimental	Participants will receive 3-month access to the WW digital program and the PolyRules! app. Receives: Behavioral: WW + PolyRules!

What is being measured

The primary outcome is the main question the study is designed to answer.

BMI at Three Months
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 WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI.
Measured: Baseline, 3 months

Secondary outcomes (7)

Correlation Between Dietary Logging Frequency and BMI Change.
The statistical association between the cumulative number of days food logs were submitted and the change in Body Mass Index (BMI). This will be analyzed using a Pearson correlation coefficient to determine the strength and direction of the relationship.
Measured: From randomization to the end of treatment at 12 weeks
Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.
The statistical association between the cumulative number of days inhibitory control training sessions were completed and the change in Body Mass Index (BMI). This will be analyzed using a Pearson correlation coefficient to determine the strength and direction of the relationship.
Measured: From baseline to end of treatment at 12 weeks.
Mean Percentage of Days With Dietary Self-monitoring
Dietary self-monitoring adherence was calculated for each participant as the percentage of days they recorded a food log out of the total days in the 12-week intervention period (84 days total). This measure reports the mean percentage across all participants within each group.
Measured: From baseline to end of treatment at 12 weeks.
Completion Rate of Weight Self-monitoring
Completion rate of weight self-monitoring is defined as the frequency of weekly body weight entries recorded. The outcome is calculated as the percentage of entries with a recorded weight out of the total number of weeks in the 12-week intervention period.
Measured: From baseline to end of treatment at 12 weeks
Completion Rate of Inhibitory Control Training Sessions
Completion rate of the inhibitory control training protocol is calculated as the proportion of prescribed Inhibitory Control Training sessions successfully completed by the participant. The protocol prescribes a total of 60 30-minute training sessions over the 12-week intervention period. Adherence for each participant is calculated as the number of completed sessions divided by the total number of prescribed sessions.
Measured: From baseline to end of treatment at 12 weeks
Participant Attrition Rate at Three Months
Participant attrition rate is defined as the proportion of randomized participants who prematurely withdrew from the study prior to completing the final 12-week assessment. Withdrawal is defined as a participant's explicit statement of intent to discontinue the intervention and/or the remaining study assessments after randomization. This is calculated as the total number of participants who withdrew divided by the total number of participants randomized (N=30).
Measured: From enrollment to end of treatment at 12 weeks
Number of Participants Who Completed Timepoint Follow-ups
This measure assesses retention and study feasibility by counting the total number of randomized participants who successfully completed the primary cognitive assessment at the 12-week post-randomization timepoint (N=30).
Completion is defined as the successful administration and completion of the cognitive battery. Participants who withdrew consent or were lost to follow-up post-randomization are counted as non-completers. Participants who withdrew prior to randomization are excluded from this count.
Measured: From Baseline to 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 20214 Jun 2022

First posted10 Feb 2021
Study start12 Mar 2021
Primary completion31 Jul 2021
Study completion4 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
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: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04747886
Sponsor's protocol ID: STUDY00001164
Status last verified: Jun 2026
First submitted: 25 Jan 2021
Last updated: 17 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

All Overweight and Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2026. 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: a Pilot Study
ClinicalTrials.gov ID: NCT04747886
Acronym / sponsor ID: STUDY00001164
Conditions: Overweight and Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: 12 Mar 2021 (actual)
Primary completion: 31 Jul 2021 (actual)
Study completion: 4 Jun 2022 (actual)
First posted: 10 Feb 2021 (actual)
Results: Posted 29 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
WW Only	Active comparator	Behavioral: WW OnlyParticipants will receive 3-month access to the WW digital program.
WW + PolyRules!	Experimental	Behavioral: WW + PolyRules!Participants will receive 3-month access to the WW digital program and the PolyRules! app.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 years of age or older
Read, write and speak English with acceptable visual acuity
BMI between 25-40 kg/m^2

Key exclusion criteria (3 listed)

Currently enrolled in weight loss interventions or undergoing bariatric surgery
Pregnant women
Individuals with severe cognitive delays or visual/hearing impairment

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
WW OnlyWW is a structured behavioral weight management program that focuses on diet, physical activity and mindset skills. 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. Specifically, the WW program assigns SmartPoints values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, non-fat yogurt, fish).	Behavioural	WW Only
WW + PolyRules!In addition to WW, 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	WW + PolyRules!

Primary outcome

BMI at Three Months
Time frame: Baseline, 3 months
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 WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI.

7 secondary outcomes

Correlation Between Dietary Logging Frequency and BMI Change.
Time frame: From randomization to the end of treatment at 12 weeks
Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.
Time frame: From baseline to end of treatment at 12 weeks.
Mean Percentage of Days With Dietary Self-monitoring
Time frame: From baseline to end of treatment at 12 weeks.
Completion Rate of Weight Self-monitoring
Time frame: From baseline to end of treatment at 12 weeks
Completion Rate of Inhibitory Control Training Sessions
Time frame: From baseline to end of treatment at 12 weeks
Participant Attrition Rate at Three Months
Time frame: From enrollment to end of treatment at 12 weeks
Number of Participants Who Completed Timepoint Follow-ups
Time frame: From Baseline to 12 Weeks

Results and safety

Results posted to the registry on 29 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WW Only	14	13
WW + PolyRules!	20	16

Primary outcome: BMI at Three Months

Time frame: Baseline, 3 months. Mean (Standard Deviation). Unit: kg/m^2

Measure	WW Only n = 13	WW + PolyRules! n = 16
Value	34.53 (6.5)	34.43 (6.2)

Population analysed: WW Only included 13 participants who contributed baseline data. WW + PolyRules! included 17 participants who contributed baseline data, one participant in this group withdrew after providing baseline data but before completing the intervention and providing post-intervention data for a final analytic sample of 29.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the time of each participant's consent until the active intervention (12 weeks) and end of study procedures were completed, totaling 14-16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WW Only	0 of 13 (0%)	0 of 13 (0%)	0 of 13
WW + PolyRules!	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Limitations and caveats (from the sponsor): 1. Small and homogeneous sample of participants. Individuals who took part in the study were highly educated, affluent and 86.7% were women. 2. Short intervention duration compared to other weight management trials. 3. Reliance on self-report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Overweight and Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)

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 WW Only and WW + 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 3 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 17 Aug 2026. 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?

Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

BMI at Three Months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04747886.

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 17 Aug 2026.