the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus

April 22, 2023 updated by: Na Liu

The Study of the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus and Its Intervention

Research Objectives This study aims to investigate the relationship between executive function and diet adherence in patients with type 2 diabetes mellitus (T2DM) from both subjective and objective perspectives and to clarify the effect of executive function intervention of inhibitory control training based on computer on diet adherence.

Research design This study includes three parts. In Part 1, the subjective measurement (questionnaire) and objective measurement (cognitive task performance) are combined to comprehensively explore the relationship between executive function and diet adherence in patients with type 2 diabetes. In the second part, ERP technology is used to investigate the neural mechanism of inhibitory control in type 2 diabetic patients with different diet adherence. Part III is a randomized controlled trial. The control group adopts non-food-related inhibitory control training, and the experimental group adopts food-related inhibitory control training.

Participants The inclusion criteria were as follows: T2DM patients who (1) have met the 1999 WHO diagnostic criteria for diabetes; (2) have a course of disease ≥6 months; (3) have an age ≥18 years old; (4) have good verbal communication and understanding skills; (5) have normal vision or corrected vision, no color blindness or color asthenia; (6) have normal finger function and ability to do key reactions; (7) have a MoCA score ≥25; and (8) have given informed consent and were willing to participate in the study. Patients who (1) have a history of cerebrovascular disease or other central nervous system injury and (2) have difficulty completing the questionnaire or the computer-based cognitive measurement tasks were excluded.

Sampling method and sample size In Part 1, convenience sampling method is used, and the sample size is calculated according to 10-15 times of the research indicators. A total of 23 research indicators were included in the analysis of this study, and at least 230 are needed. Considering the loss rate of 20%, a total of 276 subjects are needed. In the second part, convenience sampling method is also used. According to the literature reviewed, the effect size was 0.93, taking α=0.05, β=0.80, and the sample size was 40 cases calculated by GPower3.1.9.7 software. The sample size is increased by 20% considering the withdrawal of participants and sample loss. Finally, the sample size n1 (number of patients with high diet compliance) =n2 (number of patients with low diet compliance) =50 cases. In Part III, the convenience sampling method is used. The sample size was determined as 60 cases by referring to previous studies. Patients with type 2 diabetes who meet the inclusion criteria are numbered from 1 to 60. Starting from any row or column in the random number table, two digits are read in turn as a random number under the number, and then all the random numbers are sequenced from small to large. This study is a single-blind trial, and only the investigators themselves are aware of the group assignment, and the subjects are unaware of the group assignment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In Part 1, the Dietary Behavior Adherence Scale for Patients with Type 2 Diabetes Mellitus is used to measure participants' dietary adherence; the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) is used to subjectively measure participants' executive function; Stop signal task (SST) and Stroop task are used objectively measure participants' executive function. In the second part, ERP technology is used to investigate the neural mechanism of executive function in type 2 diabetic patients with different diet adherence. Part III is a randomized controlled trial. The control group adopts non-food-related inhibitory control training, and the experimental group adopts food-related inhibitory control training. Both training tasks are computer-based, with participants performing a simple keypress response.

Study Type

Interventional

Enrollment (Anticipated)

436

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of Type 2 Diabetes Mellitus
  • Must have a course of disease ≥6 months
  • Must have an age ≥18 years old
  • Must have good verbal communication and understanding skills
  • Must have normal vision or corrected vision, no color blindness or color asthenia
  • Must have normal finger function and ability to do key reactions
  • Must have a Montreal Cognitive Assessment (MoCA) score ≥25
  • Must have given informed consent and were willing to participate in the study.

Exclusion Criteria:

  • Have a history of cerebrovascular disease or other central nervous system injury
  • Have difficulty completing the questionnaire or the computer-based cognitive measurement tasks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
Behavioral: Food-related inhibitory control training based on computer
Inhibitory control training tasks are performed using E-Prime 3.0 software to present stimuli based on computer. The Go/no-go task is used as the training task, and the stimulus materials are high-calorie and low-calorie food pictures. The training lasted for 5 days, once a day, and the total duration of each training is about 15 minutes.
Placebo Comparator: control group
Behavioral: Non-food-related inhibitory control training based on computer
Inhibitory control training tasks are performed using E-Prime 3.0 software to present stimuli based on computer. The Go/no-go task is used as the training task, and the stimulus materials are non-food pictures. The training lasted for 5 days, once a day, and the total duration of each training is about 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diet adherence
Time Frame: before the intervention
The scores of The Dietary Behavior Adherence Scale for Patients with Type 2 Diabetes Mellitus are reported, the minimum and maximum values are 23 and 115, respectively. And higher scores mean a better outcome.
before the intervention
diet adherence
Time Frame: one month after the intervention
The scores of The Dietary Behavior Adherence Scale for Patients with Type 2 Diabetes Mellitus are reported, the minimum and maximum values are 23 and 115, respectively. And higher scores mean a better outcome.
one month after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Na Liu

Investigators

  • Principal Investigator: Na Liu, Air Force Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 5, 2023

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 1, 2023

First Submitted That Met QC Criteria

April 22, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K202301-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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