Inhibitory Control Adult Weight Management
Supplementing Evidence-based Commercial Weight Management Program With Inhibitory Control Training: a Pilot Study
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2022
CompletedResults Posted
Study results publicly available
August 29, 2024
CompletedAugust 29, 2024
August 1, 2024
5 months
January 25, 2021
June 15, 2022
August 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 3 months
Other Outcomes (7)
Change in Visuo-spatial Working Memory Based on Performance on the Corsi Task.
Baseline, 3 months
Change in Performance on the Letter-number Task.
Baseline, 3 months
Change in Performance on the N-back Task.
Baseline, 3 months
- +4 more other outcomes
Study Arms (2)
WW Only
ACTIVE COMPARATORParticipants will receive 3-month access to the WW digital program.
WW + PolyRules!
EXPERIMENTALParticipants will receive 3-month access to the WW digital program and the PolyRules! app.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- Read, write and speak English with acceptable visual acuity
- BMI between 25-40 kg/m\^2
You may not qualify if:
- Currently enrolled in weight loss interventions or undergoing bariatric surgery
- Pregnant women
- Individuals with severe cognitive delays or visual/hearing impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pacific Design Center
West Hollywood, California, 90069, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Dr. Sarah-Jeanne Salvy
- Organization
- Cedars-Sinai Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah-Jeanne Salvy, PhD
Cedars-Sinai Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Medicine
Study Record Dates
First Submitted
January 25, 2021
First Posted
February 10, 2021
Study Start
March 12, 2021
Primary Completion
July 31, 2021
Study Completion
June 4, 2022
Last Updated
August 29, 2024
Results First Posted
August 29, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share