<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04433598</url>
  </required_header>
  <id_info>
    <org_study_id>GS48062</org_study_id>
    <nct_id>NCT04433598</nct_id>
  </id_info>
  <brief_title>Effectiveness of Nutrition Education Intervention on Glycemic Control (HbA1c)</brief_title>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universiti Putra Malaysia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To evaluate the effect of nutrition education intervention (NEI) on glycemic control and&#xD;
      other diabetes-related outcomes of patients with type 2 diabetes mellitus (T2DM), at a&#xD;
      tertiary health Center, in Basrah, Iraq. Participants and setting: The study was involved 208&#xD;
      participants (20-64 years) diagnosed with T2DM at least 6 months before the study and had&#xD;
      poorly controlled diabetes (HbA1c ≥ 7%). The study setting is the outpatient clinics at a&#xD;
      tertiary health Center in Basrah, Iraq. Intervention: This randomized controlled trial&#xD;
      design. The participants were allocated to either intervention group (IG), or control group&#xD;
      (CG). A total sample size was 208 participants with T2DM (104 per group) to detect a 5%&#xD;
      reduction in glycemic control (HbA1c), at visit time 1 (3 months after intervention) and&#xD;
      visit time 2 (3 months after following up) and allowing 30% drop out rate. The intervention&#xD;
      period is 22 weeks long with the following mechanisms: the curriculum (twelve weekly classes,&#xD;
      1 to 1.5 hrs. each); follow-up classes (one monthly each lasting 1 to 1.5 hrs.); nutrition&#xD;
      education materials (pamphlets) and reminder calling before each session for IG. The&#xD;
      participants in the CG received classes about diabetes and its complications with some advice&#xD;
      related to physical activity on different days on IG. Besides, they received the same&#xD;
      pamphlets at the end of the study. Both groups continued with the usual medical care at&#xD;
      respective Center. The participants in the IG group received nutrition education classes. The&#xD;
      classes are offered in the meeting hall in the center by face- to- face using the simple&#xD;
      Arabic language, which utilized lecture method using PowerPoint presentations and whiteboard,&#xD;
      lecture-discussion groups, and related videos. The nutrition education classes were&#xD;
      administered by a nutritionist and a team of endocrinologists, and diabetes experts. The&#xD;
      content and strategies utilized in the classes were based on Health Belief Model theory&#xD;
      (HBM). Outcomes: the outcomes were evaluated at visit time 1 (at 12 weeks of intervention)&#xD;
      and at visit time 2 (at 22 weeks of the follow-up period) for both groups. The outcomes were&#xD;
      included HbA1c, metabolic parameters, nutritional status, HBM constructs, diabetes knowledge&#xD;
      (DK), and health literacy (HL). It is assumed that the NEI will reduce the HbA1c levels by at&#xD;
      least 0.5% at three months and the levels will be lower in IG compared with CG, and the lower&#xD;
      levels will be continued at 22 weeks in IG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study: To evaluate the effect of nutrition education intervention (NEI) on&#xD;
      glycemic control and other diabetes-related outcomes of patients with type 2 diabetes&#xD;
      mellitus (T2DM), at a tertiary health Center, in Basrah, Iraq. Specific objectives: (i) To&#xD;
      describe and compare the glycemic control (HbA1c), socio-demographic status (age, gender,&#xD;
      marital status, and employment), medical characteristics (duration of diabetes, family&#xD;
      history, and blood pressure measures), nutritional status (anthropometric measurements,&#xD;
      metabolic parameters, and dietary intake). Besides, lifestyle characteristics (physical&#xD;
      activity level, smoking, and alcohol drinking), health belief model (HBM) constructs&#xD;
      (susceptibility, severity, benefits, barriers, and self-efficacy), diabetes knowledge (DK),&#xD;
      and health literacy (HL) level of patients with T2DM at baseline (T0), between intervention&#xD;
      and control groups. (ii) To evaluate the effectiveness of NEI on glycemic control (HbA1c),&#xD;
      medical characteristics, nutritional status, lifestyle characteristics, HBM constructs, DK,&#xD;
      and HL level of patients within and between intervention and control groups at visit time 1&#xD;
      (T1), and visit time 2 (T2).&#xD;
&#xD;
      Participants and setting: The study was a parallel, randomized design, was conducted from&#xD;
      June to December 2019, and involved 208 participants (20-64 years) diagnosed with T2DM at&#xD;
      least 6 months before the study and had poorly controlled diabetes (HbA1c ≥ 7%). The study&#xD;
      setting is the outpatient clinics at Faiha Specialized Diabetes, Endocrine, and Metabolism&#xD;
      Centre (FDEMC), Basrah, Iraq. This study was involved in three phases based on the&#xD;
      Generalized Model for Health Program Planning. Phase I included a cross-sectional study for&#xD;
      need assessment among 280 participants with T2DM. The data that were collected included&#xD;
      socio-demographic status, medical characteristics, nutritional status, lifestyle behavior,&#xD;
      and health literacy. Phase II included the preparation and development of nutrition education&#xD;
      materials based on HBM. Phase III was the randomized controlled trial among 208 participants&#xD;
      with T2DM who attended the program were selected according to specific criteria. Participants&#xD;
      aged between 20 and 64 years old, without hearing or vision problems and severe illnesses&#xD;
      like cancers and renal failure were included in the study. The eligible participants signed&#xD;
      the study consent form after the screening. The data were collected at baseline (T0), visit&#xD;
      time 1 after 12 weeks of intervention (T1), and visit time 2 after 10 weeks of follow-up&#xD;
      (T2). The institutional ethics committees approved the study and all participants provide&#xD;
      their written consent before study enrollment.&#xD;
&#xD;
      Intervention: The participants were allocated using simple randomization to either&#xD;
      intervention group (IG), or control group (CG). A total sample size was 208 participants with&#xD;
      T2DM (104 per group) to detect a 5% reduction in glycemic control (HbA1c), at visit time 1 (3&#xD;
      months after intervention) and visit time 2 (3 months after following up) and allowing 30%&#xD;
      drop out rate. The CONSORT report was followed up, wherever possible. The allocation was&#xD;
      concealed using serially numbered opaque closed envelopes until intervention is assigned. The&#xD;
      intervention period was 12 weeks long with the following mechanisms: the curriculum (twelve&#xD;
      weekly classes, 1 to 1.5 hrs. each); follow-up classes (one monthly each lasting 1 to 1.5&#xD;
      hrs.); nutrition education materials (pamphlets) and reminder calling before each session for&#xD;
      IG. The pamphlets were distributed for use at home as individual goal-setting activities. The&#xD;
      participants were bucked up to bring a friend or a family member. While the follow-up period&#xD;
      was 10 weeks long with the following mechanisms: monthly follow-up class, and reminder&#xD;
      calling before each class for IG. The participants in the CG received classes about diabetes&#xD;
      and its complications with some advice related to physical activity on different days on IG.&#xD;
      Besides, they received the same educational materials (pamphlets) at the end of the study.&#xD;
      Both groups continued with the usual medical care at respective Center. All the classes are&#xD;
      offered in the meeting hall in the Center by face- to- face using the local Arabic language,&#xD;
      which utilized the lecture method using PowerPoint presentations and whiteboard,&#xD;
      lecture-discussion groups with household measurements to estimate the portion size and&#xD;
      related videos or animations. The classes were concentrated on plate method and eating&#xD;
      vegetables before carbohydrates as a simplified manner for participants with low HL. it were&#xD;
      administered by a nutritionist and a team of endocrinologists, and diabetes experts. The&#xD;
      content and strategies utilized in the intervention were based on Health Belief Model theory&#xD;
      (HBM). Standardized questionnaires for data collection are considered as appropriate measures&#xD;
      for the study outcomes and suitable for use it with the target patients.&#xD;
&#xD;
      Evaluation of intervention: The evaluations of the effectiveness of NEI were conducted at T1&#xD;
      and T2, on the following outcomes: (i) Clinical outcomes: HbA1c (%), lipid profile in mmol/L,&#xD;
      and blood pressure in mmHg. (ii) Nutritional status: BMI in kg/m2, and dietary intake (energy&#xD;
      intake in kilocalories per day, macronutrient intake in gram per day, vegetable and fruit&#xD;
      intake in servings per day). (iii) Physical activity level in MET-min/week, and (iv)&#xD;
      Potential behavior mediators: HBM constructs (susceptibility, severity, benefits, barriers,&#xD;
      and self-efficacy), DK, and HL level. The outcome objective is to evaluate the changes&#xD;
      between groups at T1 and T2 for HbA1c, lipid profile, and blood pressure, BMI, and dietary&#xD;
      intake, physical activity level, HBM constructs, DK, and HL level. The study hypothesis: (i)&#xD;
      intervention will reduce the HbA1c at T1 and these levels will be significantly lower in IG&#xD;
      than CG, and these levels will remain significantly lower at T2. (ii) IG will have&#xD;
      significantly better results in other diabetes-related outcomes that including nutritional&#xD;
      status, physical activity level, blood pressure; HBM constructs, DK, and HL scores at T1, and&#xD;
      these significantly improved results will maintain at T2 compared to CG. (iii) IG compared to&#xD;
      CG will have significantly more patients who achieve a good HbA1c at T1 and will remain&#xD;
      significantly lower at T2.&#xD;
&#xD;
      Data analysis: The general linear model (GLM) repeated measures ANCOVA was performed to&#xD;
      measure the changes over time with the adjustment of significant differences at baseline as&#xD;
      covariates. An intention-to-treat analysis (ITT) of all the outcomes of the study was&#xD;
      achieved for non-adherence and missing outcomes. The level of significance was set at p &lt;&#xD;
      0.05 for a two-tailed test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2019</start_date>
  <completion_date type="Actual">February 2, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a single-blinded parallel-randomized controlled trial (RCT) where type 2 diabetes mellitus (T2DM) participants were recruited in the study. The nutrition education intervention was consisted of four components: (1) the curriculum (twelve weekly sessions, 1 to 1.5 hrs. each); (2) follow-up sessions (bi-monthly, each lasting 1 to 1.5 hrs.); (3) Educational materials and (4) reminder calling before each session. The nutrition education intervention sessions will be presented in ten groups of ten participants (10 participants each day). The participants were backed up to bring a friend or a family member. The groups have been formed based on recruitment time; therefore, the nutrition education intervention sessions were staggered over the study period. This study has been presented the nutrition education intervention in the form of an easy and simple dietary plan management like plate method or consumption of vegetables before carbohydrates.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>This study was a single blinded parallel-randomized controlled trial, where the blinding assignment was after assignment of intervention. Participants, care providers and medical lab technicians (those assessing outcomes) at FDEMC were blinded after assignment to intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Glycated Hemoglobin (HbA1c), taken from medical records (%) change</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of energy intake, using 3-days food record, mean energy intake (kcal/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrates intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of carbohydrates intake, using 3-days food record, mean carbohydrates intake (gram/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of protein intake, using 3-days food record, mean protein intake (gram/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of fat intake, using 3-days food record, mean fat intake (gram/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary fiber intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of dietary fiber intake, using 3-days food record, mean fiber intake (gram/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fruit intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of fruit intake, using 3-days food record, mean fruit intake (servings/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vegetable intake</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of vegetable intake, using 3-days food record, mean vegetable intake (servings/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of physical activity, using S-IPAQ questionnaire, mean physical activity (MET-min/week)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of waist circumference, using tape measure, mean waist circumference (cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of weight, using weight scale, mean weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of BMI, using weight and height scale to calculate BMI, mean BMI, (kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of systolic and diastolic blood pressure, taken from medical records, mean systolic and diastolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting blood sugar</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of fasting blood sugar, taken from medical records, mean fasting blood sugar (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of total cholesterol, taken from medical records, mean total cholesterol (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of LDL-cholesterol, taken from medical records, mean LDL-cholesterol (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of HDL-cholesterol, taken from medical records, mean HDL-cholesterol (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of triglycerides, taken from medical records, mean triglycerides (mmol/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health belief model (HBM) constructs</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of HBM constructs, using questionnaire, mean HBM construct score (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes knowledge (DK)</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks</time_frame>
    <description>Assessment of DK, using Michigan diabetes questionnaire (true and false version), mean DK score (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health literacy (HL)</measure>
    <time_frame>From baseline to 12 weeks and 22 weeks (%)</time_frame>
    <description>Assessment of HL, using S-TOFHLA questionnaire, mean HL score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Diet, Healthy</condition>
  <condition>Health Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Nutrition Education Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the participants the intervention group under went to Nutrition Education Intervention program were received the developed educational materials (pamphlets).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition Education Intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Nutrition Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants with a confirmed diagnosis of T2DM for at least one year prior to the&#xD;
             study.&#xD;
&#xD;
          2. Iraqi participants aged 20-64 years.&#xD;
&#xD;
          3. Both males and females.&#xD;
&#xD;
          4. Current Basrah residents.&#xD;
&#xD;
          5. Arabic speaking participants due to the need for discussion in focus groups.&#xD;
&#xD;
          6. Participant are able to read or write.&#xD;
&#xD;
          7. Participants with marginal health literacy and above.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious, severe illnesses (such as renal failure, myocardial infarction, cancer or&#xD;
             surgery within the previous 4 weeks).&#xD;
&#xD;
          2. Intake of oral contraceptive drugs, steroid drugs or any hormones effects on blood&#xD;
             glucose levels.&#xD;
&#xD;
          3. Participants with hearing or vision problems.&#xD;
&#xD;
          4. Heavy smokers (more than 40 cigarettes a day).&#xD;
&#xD;
          5. Pregnant women with gestational diabetes mellitus or lactating women.&#xD;
&#xD;
          6. Planning to move from the study area during the study period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Barakatun-Nisak M Yusof, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universiti Putra Malaysia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al-Faiha Diabetes Endocrine and Metabolism Center (FDEMC)</name>
      <address>
        <city>Basrah</city>
        <zip>61001</zip>
        <country>Iraq</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iraq</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiti Putra Malaysia</investigator_affiliation>
    <investigator_full_name>Saman Agad Hashim</investigator_full_name>
    <investigator_title>Nutritionist</investigator_title>
  </responsible_party>
  <keyword>glycemic control</keyword>
  <keyword>nutrition education</keyword>
  <keyword>nutritional status</keyword>
  <keyword>plate method</keyword>
  <keyword>vegetables</keyword>
  <keyword>health literacy</keyword>
  <keyword>diabetes knowledge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04433598
org study id: GS48062
nct id: NCT04433598
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a single-blinded parallel-randomized controlled trial (RCT) where type 2 diabetes mellitus (T2DM) participants were recruited in the study. The nutrition education intervention was consisted of four components: (1) the curriculum (twelve weekly sessions, 1 to 1.5 hrs. each); (2) follow-up sessions (bi-monthly, each lasting 1 to 1.5 hrs.); (3) Educational materials and (4) reminder calling before each session. The nutrition education intervention sessions will be presented in ten groups of ten participants (10 participants each day). The participants were backed up to bring a friend or a family member. The groups have been formed based on recruitment time; therefore, the nutrition education intervention sessions were staggered over the study period. This study has been presented the nutrition education intervention in the form of an easy and simple dietary plan management like plate method or consumption of vegetables before carbohydrates.
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: This study was a single blinded parallel-randomized controlled trial, where the blinding assignment was after assignment of intervention. Participants, care providers and medical lab technicians (those assessing outcomes) at FDEMC were blinded after assignment to intervention.
measure: Glycemic control
time frame: From baseline to 12 weeks and 22 weeks
description: Glycated Hemoglobin (HbA1c), taken from medical records (%) change
measure: Energy intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of energy intake, using 3-days food record, mean energy intake (kcal/day)
measure: Carbohydrates intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of carbohydrates intake, using 3-days food record, mean carbohydrates intake (gram/day)
measure: Protein intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of protein intake, using 3-days food record, mean protein intake (gram/day)
measure: Fat intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of fat intake, using 3-days food record, mean fat intake (gram/day)
measure: Dietary fiber intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of dietary fiber intake, using 3-days food record, mean fiber intake (gram/day)
measure: Fruit intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of fruit intake, using 3-days food record, mean fruit intake (servings/day)
measure: Vegetable intake
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of vegetable intake, using 3-days food record, mean vegetable intake (servings/day)
measure: Physical activity
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of physical activity, using S-IPAQ questionnaire, mean physical activity (MET-min/week)
measure: Waist circumference
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of waist circumference, using tape measure, mean waist circumference (cm)
measure: Weight
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of weight, using weight scale, mean weight (kg)
measure: BMI
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of BMI, using weight and height scale to calculate BMI, mean BMI, (kg/m2)
measure: Blood pressure
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of systolic and diastolic blood pressure, taken from medical records, mean systolic and diastolic blood pressure (mmHg)
measure: Fasting blood sugar
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of fasting blood sugar, taken from medical records, mean fasting blood sugar (mmol/L)
measure: Total cholesterol
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of total cholesterol, taken from medical records, mean total cholesterol (mmol/L)
measure: LDL-cholesterol
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of LDL-cholesterol, taken from medical records, mean LDL-cholesterol (mmol/L)
measure: HDL-cholesterol
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of HDL-cholesterol, taken from medical records, mean HDL-cholesterol (mmol/L)
measure: Triglycerides
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of triglycerides, taken from medical records, mean triglycerides (mmol/L)
measure: Health belief model (HBM) constructs
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of HBM constructs, using questionnaire, mean HBM construct score (%)
measure: Diabetes knowledge (DK)
time frame: From baseline to 12 weeks and 22 weeks
description: Assessment of DK, using Michigan diabetes questionnaire (true and false version), mean DK score (%)
measure: Health literacy (HL)
time frame: From baseline to 12 weeks and 22 weeks (%)
description: Assessment of HL, using S-TOFHLA questionnaire, mean HL score
arm group label: Nutrition Education Intervention
arm group type: Experimental
description: the participants the intervention group under went to Nutrition Education Intervention program were received the developed educational materials (pamphlets).
arm group label: Treatment as usual
arm group type: No Intervention
description: 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.
intervention type: Behavioral
intervention name: Nutrition Education Intervention
description: 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.
arm group label: Nutrition Education Intervention
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Barakatun-Nisak M Yusof, PhD
role: Study Director
affiliation: Universiti Putra Malaysia
facility: 
country: Iraq
responsible party type: Principal Investigator
investigator affiliation: Universiti Putra Malaysia
investigator full name: Saman Agad Hashim
investigator title: Nutritionist
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No