Effectiveness of Nutrition Education Intervention on Glycemic Control (HbA1c)

June 15, 2020 updated by: Saman Agad Hashim, Universiti Putra Malaysia

Effectiveness of Nutrition Education Intervention on Glycemic Control, and Other Diabetes-Related Outcomes of Patients With Type 2 Diabetes Mellitus In Basrah, Iraq.

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 1.5 hrs. each); follow-up classes (one monthly each lasting 1 to 1.5 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 0.5% 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 1.5 hrs. each); follow-up classes (one monthly each lasting 1 to 1.5 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 mmol/L, and blood pressure in mmHg. (ii) Nutritional status: BMI in kg/m2, 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-min/week, 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 < 0.05 for a two-tailed test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
208

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Iraq
      • Basrah, Iraq, 61001
        • Al-Faiha Diabetes Endocrine and Metabolism Center (FDEMC)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Participants with a confirmed diagnosis of T2DM for at least one year prior to the study.
  2. Iraqi participants aged 20-64 years.
  3. Both males and females.
  4. Current Basrah residents.
  5. Arabic speaking participants due to the need for discussion in focus groups.
  6. Participant are able to read or write.
  7. Participants with marginal health literacy and above.

Exclusion Criteria:

  1. Serious, severe illnesses (such as renal failure, myocardial infarction, cancer or surgery within the previous 4 weeks).
  2. Intake of oral contraceptive drugs, steroid drugs or any hormones effects on blood glucose levels.
  3. Participants with hearing or vision problems.
  4. Heavy smokers (more than 40 cigarettes a day).
  5. Pregnant women with gestational diabetes mellitus or lactating women.
  6. Planning to move from the study area during the study period

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nutrition Education Intervention
the participants the intervention group under went to Nutrition Education Intervention program were received the developed educational materials (pamphlets).
Behavioral: Nutrition Education Intervention
Each participant were interviewed by face- to- face using Arabic language, after 1 hour when they finish their assessment by medical doctors. The researcher was collected the data from the participants in a special room for 10-15 minutes, after only one hour of completing the necessary tests with the treating physician to allow participants to go for a meal before the nutrition education starts.12 classes (1:30 hour each session):- 100 participants / 5 days = 20 participants each class was offered twice per day to cover the number of participants and to enhance attendance for them can not attend at first morning. the classes was designed according to health belief model (HBM). The topics were about the type 2 diabetes and its complications,the benefits of diabetes plate and eating vegetables before carbohydrates.
No Intervention: Treatment as usual
the participants in the control group were received the usual medical care at their respective Center.The developed educational materials (pamphlets) were distributed at the end of the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: From baseline to 12 weeks and 22 weeks
Glycated Hemoglobin (HbA1c), taken from medical records (%) change
From baseline to 12 weeks and 22 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Energy intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of energy intake, using 3-days food record, mean energy intake (kcal/day)
From baseline to 12 weeks and 22 weeks
Carbohydrates intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of carbohydrates intake, using 3-days food record, mean carbohydrates intake (gram/day)
From baseline to 12 weeks and 22 weeks
Protein intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of protein intake, using 3-days food record, mean protein intake (gram/day)
From baseline to 12 weeks and 22 weeks
Fat intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of fat intake, using 3-days food record, mean fat intake (gram/day)
From baseline to 12 weeks and 22 weeks
Dietary fiber intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of dietary fiber intake, using 3-days food record, mean fiber intake (gram/day)
From baseline to 12 weeks and 22 weeks
Fruit intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of fruit intake, using 3-days food record, mean fruit intake (servings/day)
From baseline to 12 weeks and 22 weeks
Vegetable intake
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of vegetable intake, using 3-days food record, mean vegetable intake (servings/day)
From baseline to 12 weeks and 22 weeks
Physical activity
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of physical activity, using S-IPAQ questionnaire, mean physical activity (MET-min/week)
From baseline to 12 weeks and 22 weeks
Waist circumference
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of waist circumference, using tape measure, mean waist circumference (cm)
From baseline to 12 weeks and 22 weeks
Weight
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of weight, using weight scale, mean weight (kg)
From baseline to 12 weeks and 22 weeks
BMI
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of BMI, using weight and height scale to calculate BMI, mean BMI, (kg/m2)
From baseline to 12 weeks and 22 weeks
Blood pressure
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of systolic and diastolic blood pressure, taken from medical records, mean systolic and diastolic blood pressure (mmHg)
From baseline to 12 weeks and 22 weeks
Fasting blood sugar
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of fasting blood sugar, taken from medical records, mean fasting blood sugar (mmol/L)
From baseline to 12 weeks and 22 weeks
Total cholesterol
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of total cholesterol, taken from medical records, mean total cholesterol (mmol/L)
From baseline to 12 weeks and 22 weeks
LDL-cholesterol
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of LDL-cholesterol, taken from medical records, mean LDL-cholesterol (mmol/L)
From baseline to 12 weeks and 22 weeks
HDL-cholesterol
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of HDL-cholesterol, taken from medical records, mean HDL-cholesterol (mmol/L)
From baseline to 12 weeks and 22 weeks
Triglycerides
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of triglycerides, taken from medical records, mean triglycerides (mmol/L)
From baseline to 12 weeks and 22 weeks
Health belief model (HBM) constructs
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of HBM constructs, using questionnaire, mean HBM construct score (%)
From baseline to 12 weeks and 22 weeks
Diabetes knowledge (DK)
Time Frame: From baseline to 12 weeks and 22 weeks
Assessment of DK, using Michigan diabetes questionnaire (true and false version), mean DK score (%)
From baseline to 12 weeks and 22 weeks
Health literacy (HL)
Time Frame: From baseline to 12 weeks and 22 weeks (%)
Assessment of HL, using S-TOFHLA questionnaire, mean HL score
From baseline to 12 weeks and 22 weeks (%)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Putra Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr. Barakatun-Nisak M Yusof, PhD, Universiti Putra Malaysia

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS48062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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