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Inhibitory Control Adult Weight Management

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WW Only
WW + PolyRules!
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pacific Design Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

WW Only

WW + PolyRules!

Arm Description

Participants will receive 3-month access to the WW digital program.

Participants will receive 3-month access to the WW digital program and the PolyRules! app.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 25, 2021
Last Updated
February 14, 2022
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04747886
Brief Title
Inhibitory Control Adult Weight Management
Official Title
Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
August 4, 2021 (Actual)
Study Completion Date
August 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WW Only
Arm Type
Active Comparator
Arm Description
Participants will receive 3-month access to the WW digital program.
Arm Title
WW + PolyRules!
Arm Type
Experimental
Arm Description
Participants will receive 3-month access to the WW digital program and the PolyRules! app.
Intervention Type
Behavioral
Intervention Name(s)
WW Only
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
WW + PolyRules!
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in BMI from baseline to 3 months to yield effect size
Description
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.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
To explore whether inhibitory control training confers any benefits in self-reported diet
Description
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.
Time Frame
Baseline, 3 months
Title
To explore whether inhibitory control training confers any increases in self-reported physical activity.
Description
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.
Time Frame
Baseline, 3 months
Title
Change in performance on the cancellation task.
Description
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.
Time Frame
Baseline, 3 months
Title
Change in performance on the countermanding task.
Description
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.
Time Frame
Baseline, 3 months
Title
Change in performance on the N-back task.
Description
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.
Time Frame
Baseline, 3 months
Title
Change in performance on the letter-number task.
Description
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.
Time Frame
Baseline, 3 months
Title
Change in visuo-spatial working memory based on performance on the Corsi task.
Description
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.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah-Jeanne Salvy, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Design Center
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Inhibitory Control Adult Weight Management

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