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Completed

NCT Number: NCT04747886

Inhibitory Control Adult Weight Management

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Design Center

West Hollywood, California, 90069, United States

About this study

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!.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WW Only

Behavioral

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!

Behavioral

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 outcomes

  1. 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.

Other outcomes

  1. Change in Visuo-spatial Working Memory Based on Performance on the Corsi Task.

    Time frame: Baseline, 3 months

    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.

  2. Change in Performance on the Letter-number Task.

    Time frame: Baseline, 3 months

    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.

  3. Change in Performance on the N-back Task.

    Time frame: Baseline, 3 months

    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.

  4. Change in Performance on the Cancellation Task.

    Time frame: Baseline, 3 months

    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.

  5. To Explore Whether Inhibitory Control Training Confers Any Increases in Self-reported Physical Activity.

    Time frame: Baseline, 3 months

    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.

  6. Change in Performance on the Countermanding Task.

    Time frame: Baseline, 3 months

    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.

  7. To Explore Whether Inhibitory Control Training Confers Any Benefits in Self-reported Diet

    Time frame: Baseline, 3 months

    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.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 10, 2021
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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