Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05841225
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-03
First Post:
2023-04-01
Brief Title:
the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus
Sponsor:
Na Liu
Organization:
Air Force Military Medical University China
Study Overview
Official Title:
The Study of the Relationship Between Executive Function and Diet Adherence in Patients With Type 2 Diabetes Mellitus and Its Intervention
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 093 taking α005 β080 and the sample size was 40 cases calculated by GPower3197 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
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 093 taking α005 β080 and the sample size was 40 cases calculated by GPower3197 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None