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Train Your Brain - Executive Function

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
online games with various food images
online games with images of flowers and songbirds
Sponsored by
USDA Grand Forks Human Nutrition Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Overweight and Obesity focused on measuring Normal weight

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: BMI 23-38 kg/m2 US citizenship Not currently dieting to lose weight and no weight loss or gain of >2 kg over the past 3 months No tobacco or e-cigarette use Not pregnant or lactating or planning to become pregnant while participating in the study Exclusion Criteria: Not a US citizen Currently dieting to lose weight Weight loss of >2 kg over the past 3 months Tobacco or e-cigarette use Pregnant or lactating or planning to become pregnant while participating in the study A history of bariatric surgery Diagnosis of major medical or psychiatric condition that would interfere with participation, including not being physically able to play the games, or a current eating disorder

Sites / Locations

  • USDA Grand Forks Human Nutrition Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EFfect-food choices

Control

Arm Description

Participants will complete four online games at least biweekly during the study.

Participants will complete four online games at least biweekly during the study.

Outcomes

Primary Outcome Measures

Change in response time
Change in online game speed of response time
Change in percent correct
Change in online game percent correct

Secondary Outcome Measures

Full Information

First Posted
May 7, 2023
Last Updated
September 25, 2023
Sponsor
USDA Grand Forks Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05938894
Brief Title
Train Your Brain - Executive Function
Official Title
The Effect of Executive Function Training on Diet and Attitudes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Grand Forks Human Nutrition Research Center

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this research is to test if playing games designed to improve an individual's executive function can change their views about the types of foods they eat. Executive function is a set of mental processes that people use every day to make decisions - such as what kinds of foods they choose to eat and when and where they eat those foods.
Detailed Description
The purpose of this study is to determine whether executive function (EF) training concurrently improves attitudes, perceptions, and consumption of nutrient-dense foods (i.e., fruits, vegetables) while worsening the same of nutrient-poor foods. In effect, the aim is to test whether EF training can promote the substitution of nutrient-poor foods with fruits and vegetables (FV), as the Dietary Guidelines for Americans (DGA) recommends regular consumption of FV as part of a healthy dietary pattern. Given the health benefits associated with consuming FV, EF training that effectively promotes increased FV intake may benefit health. For example, FV consumption is associated with the reduced risk of all-cause mortality, cardiovascular disease, diabetes, cancer, and eye and skin health. Moreover, FV consumption is associated with better mental and cognitive health.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EFfect-food choices
Arm Type
Experimental
Arm Description
Participants will complete four online games at least biweekly during the study.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will complete four online games at least biweekly during the study.
Intervention Type
Other
Intervention Name(s)
online games with various food images
Intervention Description
Participant will play a series of online games with various food images.
Intervention Type
Other
Intervention Name(s)
online games with images of flowers and songbirds
Intervention Description
Participant will play a series of online games with images of flowers and songbirds.
Primary Outcome Measure Information:
Title
Change in response time
Description
Change in online game speed of response time
Time Frame
Week 0, Week 9
Title
Change in percent correct
Description
Change in online game percent correct
Time Frame
Week 0, Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: BMI 23-38 kg/m2 US citizenship Not currently dieting to lose weight and no weight loss or gain of >2 kg over the past 3 months No tobacco or e-cigarette use Not pregnant or lactating or planning to become pregnant while participating in the study Exclusion Criteria: Not a US citizen Currently dieting to lose weight Weight loss of >2 kg over the past 3 months Tobacco or e-cigarette use Pregnant or lactating or planning to become pregnant while participating in the study A history of bariatric surgery Diagnosis of major medical or psychiatric condition that would interfere with participation, including not being physically able to play the games, or a current eating disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tori Kaster, MS
Phone
701.795.8142
Email
tori.kaster@usda.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Madelyn Kirsch, MS
Phone
701.795.8343
Email
madelyn.kirsch@usda.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Roemmich, PhD
Organizational Affiliation
USDA Grand Forks Human Nutrition Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA Grand Forks Human Nutrition Research Center
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela J Scheett, MPH, RD
Phone
701-795-8386
Email
angela.scheett@usda.gov

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/docs/nutrition-studies/nutrition-studies/
Description
Grand Forks Human Nutrition Research Center Current Nutrition Studies

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Train Your Brain - Executive Function

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