Trial Outcomes & Findings for Inhibitory Control Adult Weight Management (NCT NCT04747886)
NCT ID: NCT04747886
Last Updated: 2026-08-17
Results Overview
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.
COMPLETED
NA
34 participants
Baseline, 3 months
2026-08-17
Participant Flow
Participant milestones
| Measure |
WW Only
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
20
|
|
Overall Study
COMPLETED
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
WW Only
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
Baseline Characteristics
Inhibitory Control Adult Weight Management
Baseline characteristics by cohort
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=17 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
|
Age, Continuous
|
46.5 years
STANDARD_DEVIATION 10.0 • n=51 Participants
|
51.9 years
STANDARD_DEVIATION 13.4 • n=51 Participants
|
49.5 years
STANDARD_DEVIATION 12.14 • n=102 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=51 Participants
|
16 Participants
n=51 Participants
|
26 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=51 Participants
|
2 Participants
n=51 Participants
|
5 Participants
n=102 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=51 Participants
|
14 Participants
n=51 Participants
|
23 Participants
n=102 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=51 Participants
|
17 participants
n=51 Participants
|
30 participants
n=102 Participants
|
|
BMI
|
35.1 kg/m^2
STANDARD_DEVIATION 6.6 • n=51 Participants
|
35.3 kg/m^2
STANDARD_DEVIATION 6.3 • n=51 Participants
|
35.2 kg/m^2
STANDARD_DEVIATION 6.3 • n=102 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: 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.
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.
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=16 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
BMI at Three Months
|
34.53 kg/m^2
Standard Deviation 6.5
|
34.43 kg/m^2
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: From randomization to the end of treatment at 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=16 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Correlation Between Dietary Logging Frequency and BMI Change.
|
-0.26 Spearman's rank correlation coefficient
Interval -0.73 to 0.35
|
-0.45 Spearman's rank correlation coefficient
Interval -0.78 to 0.05
|
SECONDARY outcome
Timeframe: From baseline to end of treatment at 12 weeks.Population: 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 16.
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.
Outcome measures
| Measure |
WW Only
n=16 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Correlation Between Completed Inhibitory Control Training Sessions and BMI Change.
|
-0.506 Spearman's rank correlation coefficient
Interval -0.776 to -0.008
|
—
|
SECONDARY outcome
Timeframe: From baseline to end of treatment at 12 weeks.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.
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=16 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Mean Percentage of Days With Dietary Self-monitoring
|
66 Percentage of days
Standard Deviation 33.6
|
65.3 Percentage of days
Standard Deviation 33.3
|
SECONDARY outcome
Timeframe: From baseline to end of treatment at 12 weeksCompletion 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.
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=16 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Completion Rate of Weight Self-monitoring
|
80.8 Percentage of weigh-ins completed
Standard Deviation 27.2
|
77.0 Percentage of weigh-ins completed
Standard Deviation 30.1
|
SECONDARY outcome
Timeframe: From baseline to end of treatment at 12 weeksPopulation: 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 16.
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.
Outcome measures
| Measure |
WW Only
n=16 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Completion Rate of Inhibitory Control Training Sessions
|
60.4 Percentage of training session completed
Standard Deviation 32.4
|
—
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 12 weeksPopulation: The analysis population consists of all participants who were successfully randomized and assigned to a study arm (N=30 total; 13 in WW Arm and 17 in WW + PR Arm). There is no discrepancy between the number of participants assigned to the arms in the Participant Flow module and the numbers accounted for in this analysis population. All randomized individuals are included in the denominator for evaluation.
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).
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=17 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Participant Attrition Rate at Three Months
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to 12 WeeksPopulation: The analysis population consists of all participants who were successfully randomized and assigned to a study arm (N=30 total; 13 in WW Arm and 17 in WW + PR Arm). There is no discrepancy between the number of participants assigned to the arms in the Participant Flow module and the numbers accounted for in this analysis population. All randomized individuals are included in the denominator for evaluation.
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.
Outcome measures
| Measure |
WW Only
n=13 Participants
Participants will receive 3-month access to the WW digital program.
WW Only: 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!
n=17 Participants
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
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.
|
|---|---|---|
|
Number of Participants Who Completed Timepoint Follow-ups
|
13 Participants
|
16 Participants
|
Adverse Events
WW Only
WW + PolyRules!
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place