Inhibitory Control Adult Weight Management

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747886
• Other study ID #: STUDY00001164
• Status: Completed
• Phase: N/A
• Start date: March 12, 2021
• Est. completion date: August 4, 2021

Study information

• Verified date: February 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 4, 2021
• Est. primary completion date: August 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Read, write and speak English with acceptable visual acuity

• BMI between 25-40 kg/m^2

Exclusion Criteria:

• Currently enrolled in weight loss interventions or undergoing bariatric surgery

• Pregnant women

• Individuals with severe cognitive delays or visual/hearing impairment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• 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!
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.

Locations

Country	Name	City	State
United States	Pacific Design Center	West Hollywood	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 WW (formerly Weight Watchers) online app. This data will be used to calculate change in BMI.	Baseline, 3 months
Secondary	To explore whether inhibitory control training confers any benefits in self-reported diet	Diet quality will be assessed using participant's self-reported food intake through the WW (formerly Weight Watchers) 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, alcoholic beverages and food/beverages with added sugars.	Baseline, 3 months
Secondary	To explore whether inhibitory control training confers any increases in self-reported physical activity.	Physical activity will be assessed using participant's self-reported physical activity levels through the WW (formerly Weight Watchers) 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.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	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 outcomes.	Baseline, 3 months