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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Food-related inhibitory control training based on computer
Non-food-related inhibitory control training based on computer
Sponsored by
Na Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    experimental group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    diet adherence
    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.
    diet adherence
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2023
    Last Updated
    April 22, 2023
    Sponsor
    Na Liu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05841225
    Brief Title
    the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus
    Official Title
    The Study of the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus and Its Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 5, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Na Liu

    4. Oversight

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

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    436 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Food-related inhibitory control training based on computer
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Non-food-related inhibitory control training based on computer
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    diet adherence
    Description
    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.
    Time Frame
    before the intervention
    Title
    diet adherence
    Description
    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.
    Time Frame
    one month after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Na Liu
    Phone
    +8618702980966
    Email
    960589161@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Na Liu
    Organizational Affiliation
    Air Force Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    36501208
    Citation
    Liu Y, Yu D, Luo J, Cai S, Ye P, Yao Z, Luo M, Zhao L. Self-Reported Dietary Management Behaviors and Dietary Intake among Chinese Adults with Diabetes: A Population-Based Study. Nutrients. 2022 Dec 5;14(23):5178. doi: 10.3390/nu14235178.
    Results Reference
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    34284065
    Citation
    Adams RC, Button KS, Hickey L, Morrison S, Smith A, Bolus W, Coombs E, Randolph S, Hunt R, Kim D, Chambers CD, Lawrence NS. Food-related inhibitory control training reduces food liking but not snacking frequency or weight in a large healthy adult sample. Appetite. 2021 Dec 1;167:105601. doi: 10.1016/j.appet.2021.105601. Epub 2021 Jul 17.
    Results Reference
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    PubMed Identifier
    30213747
    Citation
    Oomen D, Grol M, Spronk D, Booth C, Fox E. Beating uncontrolled eating: Training inhibitory control to reduce food intake and food cue sensitivity. Appetite. 2018 Dec 1;131:73-83. doi: 10.1016/j.appet.2018.09.007. Epub 2018 Sep 10.
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    30176298
    Citation
    Ganor-Moscovitz N, Weinbach N, Canetti L, Kalanthroff E. The effect of food-related stimuli on inhibition in high vs. low restrained eaters. Appetite. 2018 Dec 1;131:53-58. doi: 10.1016/j.appet.2018.08.037. Epub 2018 Aug 31.
    Results Reference
    background
    PubMed Identifier
    31033438
    Citation
    Verbruggen F, Aron AR, Band GP, Beste C, Bissett PG, Brockett AT, Brown JW, Chamberlain SR, Chambers CD, Colonius H, Colzato LS, Corneil BD, Coxon JP, Dupuis A, Eagle DM, Garavan H, Greenhouse I, Heathcote A, Huster RJ, Jahfari S, Kenemans JL, Leunissen I, Li CR, Logan GD, Matzke D, Morein-Zamir S, Murthy A, Pare M, Poldrack RA, Ridderinkhof KR, Robbins TW, Roesch M, Rubia K, Schachar RJ, Schall JD, Stock AK, Swann NC, Thakkar KN, van der Molen MW, Vermeylen L, Vink M, Wessel JR, Whelan R, Zandbelt BB, Boehler CN. A consensus guide to capturing the ability to inhibit actions and impulsive behaviors in the stop-signal task. Elife. 2019 Apr 29;8:e46323. doi: 10.7554/eLife.46323.
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    Citation
    Hagen E, Erga AH, Hagen KP, Nesvag SM, McKay JR, Lundervold AJ, Walderhaug E. Assessment of Executive Function in Patients With Substance Use Disorder: A Comparison of Inventory- and Performance-Based Assessment. J Subst Abuse Treat. 2016 Jul;66:1-8. doi: 10.1016/j.jsat.2016.02.010. Epub 2016 Mar 9.
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    Citation
    Zhang X, Chen S, Chen H, Gu Y, Xu W. General and Food-Specific Inhibitory Control As Moderators of the Effects of the Impulsive Systems on Food Choices. Front Psychol. 2017 May 24;8:802. doi: 10.3389/fpsyg.2017.00802. eCollection 2017.
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