Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627114
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Effectiveness of Nutrition Education Program and Omega-3 Supplementation Among Non-alcoholic Fatty Liver Disease Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Nutrition Education Program and Omega-3 Supplementation on Body Weight Liver Enzymes Lipid Profile Among Non-Alcoholic Fatty Liver Disease Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to examine the impact of nutritional education and omega-3 supplementation in influencing body weight liver enzyme levels and lipid profiles in patients diagnosed with non-alcoholic fatty liver disease
Eligible patients who have non-alcoholic fatty liver disease are randomized to receive either nutritional education omega-3 fatty acids containing DHA and EPA or control groups
the main questions are Does the Nutrition education affect body mass liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease Does Omega-3 supplementation affect body mass liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease
The expected outcome will improvement in the laboratory liver tests liver steatosis on ultrasound and lipid profile and also decrease body weight
Eligible patients who have non-alcoholic fatty liver disease are randomized to receive either nutritional education omega-3 fatty acids containing DHA and EPA or control groups
the main questions are Does the Nutrition education affect body mass liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease Does Omega-3 supplementation affect body mass liver enzyme and lipid profile in patient with non-alcoholic fatty liver disease
The expected outcome will improvement in the laboratory liver tests liver steatosis on ultrasound and lipid profile and also decrease body weight
Detailed Description:
159 participants with non-alcoholic fatty liver disease patient who will attend Rizgary Teaching Hospital in Erbil City
In order to obtain the accurate data and representative sample Eligible patients will be randomized to one of three arms
1 those who will receive nutritional education For nutritional education intervention Theory of planned behavior-based interventions for the non-alcoholic fatty liver disease patients will include three educational sessions
2 those who will receive omega-3 supplements the dose of omega-3 DHA EPA will be 1000 mg twice daily
or
3 to a control group who will not receive any intervention who receive routine care at the outpatient clinic
Data collection will depend on face-to-face interviews including baseline using validated questionnaires ultrasonography and laboratory test liver enzyme and lipid profile at first visit mid and after 12 weeks of intervention
Tools for data collection The questionnaire that will be developed for the purpose of data collection Data will collect through using the questionnaire that consisted of the following parts Baseline characteristics of the study participants such as name age sex marital status level of education occupation mobile number body mass index and theory of planned behavior will construct TPB who will receive nutritional education intervention for a NAFLD diagnosis ultrasound proof of fatty liver stage I or above and biochemical parameter such as an elevated level of liver enzymes will require An experienced radiologist will do the ultrasonography The grade of fatty liver will determine based on hepatic parenchymal brightness by ultrasound and established methods will use to test the livers biochemical parameters such as lipid profile cholesterol LDL cholesterol HDL Triglycerides and Total cholesterol and liver AST ALT ALP and GGT And measuring body mass index will be measure at the baseline and after 12-weeks of intervention among NAFLD patients who will receive either nutritional education omega-3 supplementation and control group The questionnaire will modify based on the literature review and feedback of experts which is applicable and specific to the study also translated to Kurdish language
The validity of the study
Tools will be designed by the researcher after reviewing the relevant literature and tested for its content validity The questionnaire will be sent to panel of experts from different health specialty such as Community health nursing hepatologist medicine community medicine specialist to assess the relevance of tool with title and objectives The responses will be represented in four points score ranging from 4-1 4 strongly relevant 3 relevant 2 little relevant and 1 not relevant by use Liker scale
The Reliability of the study
Consistency of questionnaire will be tested by Cronbachs alpha test test-re-test reliability will be checked on that answered the questionnaire twice A correlation analysis will be performed on the scores of the two tests observations test and knowledge test Test-Retest will be done by 10non alcoholic fatty liver disease patients who will not part of the samples
Pilot study
The pilot study will be carried out on 10 non- alcoholic fatty liver disease patients to test all tools for clarity objectivity relevance feasibility and the applicability of the tools It also will conduct to identify any problem associated with administering the tools and measure the time needed for data collection then the necessary modifications will be conducted accordingly Data included in pilot study will be excluded from the current study
Implementation of the interventional program
The interventional program will focus on nutrition education and omega-3 supplementation ways which was implemented through the sessions The nutritional interventional program sessions were administrated individually or in small group and each session was designed and scheduled for approximately45-60 minutes
First phase an interview session The researcher will introduce herself to the NAFLD patients and explained the nature of the subject area to the approached ones who run across the inclusion criteria and agreed to take part in the study then will start The researcher will interview NAFLD patients The NAFLD patients become aware of keeping confidentiality of information and they complete the basic information forms which will prepare by the researcher According to Randomization criteria the NAFLD patients will be divide into two groups of intervention and one control
Second Phase Pre- test Pre-test assessment of each NAFLD patients in program according of each three group will expose to the pre-test questionnaire both knowledge and lifestyle BMI measures Laboratory test liver function test and lipid profile
Third Phase Intervention among NAFLD patients The Intervention among NAFLD patients According to Randomization criteria the NAFLD patients will be divide into three groups two groups of intervention and one control In nutrition education group will interview individually or in small groups
Fourth Phase Post- Test After 12 weeks of the completion the posttest will administer to collect knowledge and changes of daily life for all NAFLD patients and referring them for ultrasound and making laboratory test liver enzyme such as AST ALT ALP and GGTP and lipid profile such as cholesterol LDL cholesterol HDL Triglycerides and Total cholesterol in three groups will do
In order to obtain the accurate data and representative sample Eligible patients will be randomized to one of three arms
1 those who will receive nutritional education For nutritional education intervention Theory of planned behavior-based interventions for the non-alcoholic fatty liver disease patients will include three educational sessions
2 those who will receive omega-3 supplements the dose of omega-3 DHA EPA will be 1000 mg twice daily
or
3 to a control group who will not receive any intervention who receive routine care at the outpatient clinic
Data collection will depend on face-to-face interviews including baseline using validated questionnaires ultrasonography and laboratory test liver enzyme and lipid profile at first visit mid and after 12 weeks of intervention
Tools for data collection The questionnaire that will be developed for the purpose of data collection Data will collect through using the questionnaire that consisted of the following parts Baseline characteristics of the study participants such as name age sex marital status level of education occupation mobile number body mass index and theory of planned behavior will construct TPB who will receive nutritional education intervention for a NAFLD diagnosis ultrasound proof of fatty liver stage I or above and biochemical parameter such as an elevated level of liver enzymes will require An experienced radiologist will do the ultrasonography The grade of fatty liver will determine based on hepatic parenchymal brightness by ultrasound and established methods will use to test the livers biochemical parameters such as lipid profile cholesterol LDL cholesterol HDL Triglycerides and Total cholesterol and liver AST ALT ALP and GGT And measuring body mass index will be measure at the baseline and after 12-weeks of intervention among NAFLD patients who will receive either nutritional education omega-3 supplementation and control group The questionnaire will modify based on the literature review and feedback of experts which is applicable and specific to the study also translated to Kurdish language
The validity of the study
Tools will be designed by the researcher after reviewing the relevant literature and tested for its content validity The questionnaire will be sent to panel of experts from different health specialty such as Community health nursing hepatologist medicine community medicine specialist to assess the relevance of tool with title and objectives The responses will be represented in four points score ranging from 4-1 4 strongly relevant 3 relevant 2 little relevant and 1 not relevant by use Liker scale
The Reliability of the study
Consistency of questionnaire will be tested by Cronbachs alpha test test-re-test reliability will be checked on that answered the questionnaire twice A correlation analysis will be performed on the scores of the two tests observations test and knowledge test Test-Retest will be done by 10non alcoholic fatty liver disease patients who will not part of the samples
Pilot study
The pilot study will be carried out on 10 non- alcoholic fatty liver disease patients to test all tools for clarity objectivity relevance feasibility and the applicability of the tools It also will conduct to identify any problem associated with administering the tools and measure the time needed for data collection then the necessary modifications will be conducted accordingly Data included in pilot study will be excluded from the current study
Implementation of the interventional program
The interventional program will focus on nutrition education and omega-3 supplementation ways which was implemented through the sessions The nutritional interventional program sessions were administrated individually or in small group and each session was designed and scheduled for approximately45-60 minutes
First phase an interview session The researcher will introduce herself to the NAFLD patients and explained the nature of the subject area to the approached ones who run across the inclusion criteria and agreed to take part in the study then will start The researcher will interview NAFLD patients The NAFLD patients become aware of keeping confidentiality of information and they complete the basic information forms which will prepare by the researcher According to Randomization criteria the NAFLD patients will be divide into two groups of intervention and one control
Second Phase Pre- test Pre-test assessment of each NAFLD patients in program according of each three group will expose to the pre-test questionnaire both knowledge and lifestyle BMI measures Laboratory test liver function test and lipid profile
Third Phase Intervention among NAFLD patients The Intervention among NAFLD patients According to Randomization criteria the NAFLD patients will be divide into three groups two groups of intervention and one control In nutrition education group will interview individually or in small groups
Fourth Phase Post- Test After 12 weeks of the completion the posttest will administer to collect knowledge and changes of daily life for all NAFLD patients and referring them for ultrasound and making laboratory test liver enzyme such as AST ALT ALP and GGTP and lipid profile such as cholesterol LDL cholesterol HDL Triglycerides and Total cholesterol in three groups will do
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None