Ignite Creation Date:
2024-05-06 @ 2:48 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433598
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-06-09
Brief Title:
Effectiveness of Nutrition Education Intervention on Glycemic Control HbA1c
Sponsor:
Universiti Putra Malaysia
Organization:
Universiti Putra Malaysia
Study Overview
Official Title:
Effectiveness of Nutrition Education Intervention on Glycemic Control and Other Diabetes-Related Outcomes of Patients With Type 2 Diabetes Mellitus In Basrah Iraq
Status:
COMPLETED
Status Verified Date:
2020-06
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:
Aim To evaluate the effect of nutrition education intervention NEI on glycemic control and other diabetes-related outcomes of patients with type 2 diabetes mellitus T2DM at a tertiary health Center in Basrah Iraq Participants and setting The study was involved 208 participants 20-64 years diagnosed with T2DM at least 6 months before the study and had poorly controlled diabetes HbA1c 7 The study setting is the outpatient clinics at a tertiary health Center in Basrah Iraq Intervention This randomized controlled trial design The participants were allocated to either intervention group IG or control group CG A total sample size was 208 participants with T2DM 104 per group to detect a 5 reduction in glycemic control HbA1c at visit time 1 3 months after intervention and visit time 2 3 months after following up and allowing 30 drop out rate The intervention period is 22 weeks long with the following mechanisms the curriculum twelve weekly classes 1 to 15 hrs each follow-up classes one monthly each lasting 1 to 15 hrs nutrition education materials pamphlets and reminder calling before each session for IG The participants in the CG received classes about diabetes and its complications with some advice related to physical activity on different days on IG Besides they received the same pamphlets at the end of the study Both groups continued with the usual medical care at respective Center The participants in the IG group received nutrition education classes The classes are offered in the meeting hall in the center by face- to- face using the simple Arabic language which utilized lecture method using PowerPoint presentations and whiteboard lecture-discussion groups and related videos The nutrition education classes were administered by a nutritionist and a team of endocrinologists and diabetes experts The content and strategies utilized in the classes were based on Health Belief Model theory HBM Outcomes the outcomes were evaluated at visit time 1 at 12 weeks of intervention and at visit time 2 at 22 weeks of the follow-up period for both groups The outcomes were included HbA1c metabolic parameters nutritional status HBM constructs diabetes knowledge DK and health literacy HL It is assumed that the NEI will reduce the HbA1c levels by at least 05 at three months and the levels will be lower in IG compared with CG and the lower levels will be continued at 22 weeks in IG
Detailed Description:
The aim of the study To evaluate the effect of nutrition education intervention NEI on glycemic control and other diabetes-related outcomes of patients with type 2 diabetes mellitus T2DM at a tertiary health Center in Basrah Iraq Specific objectives i To describe and compare the glycemic control HbA1c socio-demographic status age gender marital status and employment medical characteristics duration of diabetes family history and blood pressure measures nutritional status anthropometric measurements metabolic parameters and dietary intake Besides lifestyle characteristics physical activity level smoking and alcohol drinking health belief model HBM constructs susceptibility severity benefits barriers and self-efficacy diabetes knowledge DK and health literacy HL level of patients with T2DM at baseline T0 between intervention and control groups ii To evaluate the effectiveness of NEI on glycemic control HbA1c medical characteristics nutritional status lifestyle characteristics HBM constructs DK and HL level of patients within and between intervention and control groups at visit time 1 T1 and visit time 2 T2
Participants and setting The study was a parallel randomized design was conducted from June to December 2019 and involved 208 participants 20-64 years diagnosed with T2DM at least 6 months before the study and had poorly controlled diabetes HbA1c 7 The study setting is the outpatient clinics at Faiha Specialized Diabetes Endocrine and Metabolism Centre FDEMC Basrah Iraq This study was involved in three phases based on the Generalized Model for Health Program Planning Phase I included a cross-sectional study for need assessment among 280 participants with T2DM The data that were collected included socio-demographic status medical characteristics nutritional status lifestyle behavior and health literacy Phase II included the preparation and development of nutrition education materials based on HBM Phase III was the randomized controlled trial among 208 participants with T2DM who attended the program were selected according to specific criteria Participants aged between 20 and 64 years old without hearing or vision problems and severe illnesses like cancers and renal failure were included in the study The eligible participants signed the study consent form after the screening The data were collected at baseline T0 visit time 1 after 12 weeks of intervention T1 and visit time 2 after 10 weeks of follow-up T2 The institutional ethics committees approved the study and all participants provide their written consent before study enrollment
Intervention The participants were allocated using simple randomization to either intervention group IG or control group CG A total sample size was 208 participants with T2DM 104 per group to detect a 5 reduction in glycemic control HbA1c at visit time 1 3 months after intervention and visit time 2 3 months after following up and allowing 30 drop out rate The CONSORT report was followed up wherever possible The allocation was concealed using serially numbered opaque closed envelopes until intervention is assigned The intervention period was 12 weeks long with the following mechanisms the curriculum twelve weekly classes 1 to 15 hrs each follow-up classes one monthly each lasting 1 to 15 hrs nutrition education materials pamphlets and reminder calling before each session for IG The pamphlets were distributed for use at home as individual goal-setting activities The participants were bucked up to bring a friend or a family member While the follow-up period was 10 weeks long with the following mechanisms monthly follow-up class and reminder calling before each class for IG The participants in the CG received classes about diabetes and its complications with some advice related to physical activity on different days on IG Besides they received the same educational materials pamphlets at the end of the study Both groups continued with the usual medical care at respective Center All the classes are offered in the meeting hall in the Center by face- to- face using the local Arabic language which utilized the lecture method using PowerPoint presentations and whiteboard lecture-discussion groups with household measurements to estimate the portion size and related videos or animations The classes were concentrated on plate method and eating vegetables before carbohydrates as a simplified manner for participants with low HL it were administered by a nutritionist and a team of endocrinologists and diabetes experts The content and strategies utilized in the intervention were based on Health Belief Model theory HBM Standardized questionnaires for data collection are considered as appropriate measures for the study outcomes and suitable for use it with the target patients
Evaluation of intervention The evaluations of the effectiveness of NEI were conducted at T1 and T2 on the following outcomes i Clinical outcomes HbA1c lipid profile in mmolL and blood pressure in mmHg ii Nutritional status BMI in kgm2 and dietary intake energy intake in kilocalories per day macronutrient intake in gram per day vegetable and fruit intake in servings per day iii Physical activity level in MET-minweek and iv Potential behavior mediators HBM constructs susceptibility severity benefits barriers and self-efficacy DK and HL level The outcome objective is to evaluate the changes between groups at T1 and T2 for HbA1c lipid profile and blood pressure BMI and dietary intake physical activity level HBM constructs DK and HL level The study hypothesis i intervention will reduce the HbA1c at T1 and these levels will be significantly lower in IG than CG and these levels will remain significantly lower at T2 ii IG will have significantly better results in other diabetes-related outcomes that including nutritional status physical activity level blood pressure HBM constructs DK and HL scores at T1 and these significantly improved results will maintain at T2 compared to CG iii IG compared to CG will have significantly more patients who achieve a good HbA1c at T1 and will remain significantly lower at T2
Data analysis The general linear model GLM repeated measures ANCOVA was performed to measure the changes over time with the adjustment of significant differences at baseline as covariates An intention-to-treat analysis ITT of all the outcomes of the study was achieved for non-adherence and missing outcomes The level of significance was set at p 005 for a two-tailed test
Participants and setting The study was a parallel randomized design was conducted from June to December 2019 and involved 208 participants 20-64 years diagnosed with T2DM at least 6 months before the study and had poorly controlled diabetes HbA1c 7 The study setting is the outpatient clinics at Faiha Specialized Diabetes Endocrine and Metabolism Centre FDEMC Basrah Iraq This study was involved in three phases based on the Generalized Model for Health Program Planning Phase I included a cross-sectional study for need assessment among 280 participants with T2DM The data that were collected included socio-demographic status medical characteristics nutritional status lifestyle behavior and health literacy Phase II included the preparation and development of nutrition education materials based on HBM Phase III was the randomized controlled trial among 208 participants with T2DM who attended the program were selected according to specific criteria Participants aged between 20 and 64 years old without hearing or vision problems and severe illnesses like cancers and renal failure were included in the study The eligible participants signed the study consent form after the screening The data were collected at baseline T0 visit time 1 after 12 weeks of intervention T1 and visit time 2 after 10 weeks of follow-up T2 The institutional ethics committees approved the study and all participants provide their written consent before study enrollment
Intervention The participants were allocated using simple randomization to either intervention group IG or control group CG A total sample size was 208 participants with T2DM 104 per group to detect a 5 reduction in glycemic control HbA1c at visit time 1 3 months after intervention and visit time 2 3 months after following up and allowing 30 drop out rate The CONSORT report was followed up wherever possible The allocation was concealed using serially numbered opaque closed envelopes until intervention is assigned The intervention period was 12 weeks long with the following mechanisms the curriculum twelve weekly classes 1 to 15 hrs each follow-up classes one monthly each lasting 1 to 15 hrs nutrition education materials pamphlets and reminder calling before each session for IG The pamphlets were distributed for use at home as individual goal-setting activities The participants were bucked up to bring a friend or a family member While the follow-up period was 10 weeks long with the following mechanisms monthly follow-up class and reminder calling before each class for IG The participants in the CG received classes about diabetes and its complications with some advice related to physical activity on different days on IG Besides they received the same educational materials pamphlets at the end of the study Both groups continued with the usual medical care at respective Center All the classes are offered in the meeting hall in the Center by face- to- face using the local Arabic language which utilized the lecture method using PowerPoint presentations and whiteboard lecture-discussion groups with household measurements to estimate the portion size and related videos or animations The classes were concentrated on plate method and eating vegetables before carbohydrates as a simplified manner for participants with low HL it were administered by a nutritionist and a team of endocrinologists and diabetes experts The content and strategies utilized in the intervention were based on Health Belief Model theory HBM Standardized questionnaires for data collection are considered as appropriate measures for the study outcomes and suitable for use it with the target patients
Evaluation of intervention The evaluations of the effectiveness of NEI were conducted at T1 and T2 on the following outcomes i Clinical outcomes HbA1c lipid profile in mmolL and blood pressure in mmHg ii Nutritional status BMI in kgm2 and dietary intake energy intake in kilocalories per day macronutrient intake in gram per day vegetable and fruit intake in servings per day iii Physical activity level in MET-minweek and iv Potential behavior mediators HBM constructs susceptibility severity benefits barriers and self-efficacy DK and HL level The outcome objective is to evaluate the changes between groups at T1 and T2 for HbA1c lipid profile and blood pressure BMI and dietary intake physical activity level HBM constructs DK and HL level The study hypothesis i intervention will reduce the HbA1c at T1 and these levels will be significantly lower in IG than CG and these levels will remain significantly lower at T2 ii IG will have significantly better results in other diabetes-related outcomes that including nutritional status physical activity level blood pressure HBM constructs DK and HL scores at T1 and these significantly improved results will maintain at T2 compared to CG iii IG compared to CG will have significantly more patients who achieve a good HbA1c at T1 and will remain significantly lower at T2
Data analysis The general linear model GLM repeated measures ANCOVA was performed to measure the changes over time with the adjustment of significant differences at baseline as covariates An intention-to-treat analysis ITT of all the outcomes of the study was achieved for non-adherence and missing outcomes The level of significance was set at p 005 for a two-tailed test
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