Effectiveness of Nutrition Education Intervention on Glycemic Control (HbA1c)

NCT04433598 | Completed

• 1 other identifier: GS48062
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 2 Diabetes; Diet, Healthy; Health Knowledge, Attitudes, Practice

Keywords

glycemic control; nutrition education; nutritional status; plate method; vegetables; health literacy; diabetes knowledge

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Glycated Hemoglobin (HbA1c), taken from medical records (%) change

  From baseline to 12 weeks and 22 weeks

Secondary Outcomes (20)

• Energy intake

  From baseline to 12 weeks and 22 weeks

• Carbohydrates intake

  From baseline to 12 weeks and 22 weeks

• Protein intake

  From baseline to 12 weeks and 22 weeks

• Fat intake

  From baseline to 12 weeks and 22 weeks

• Dietary fiber intake

  From baseline to 12 weeks and 22 weeks

Study Arms (2)

Nutrition Education Intervention

EXPERIMENTAL

the participants the intervention group under went to Nutrition Education Intervention program were received the developed educational materials (pamphlets).

Behavioral: Nutrition Education Intervention

Treatment as usual

NO INTERVENTION

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.

Interventions

Nutrition Education Intervention BEHAVIORAL

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.

Nutrition Education Intervention

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Al-Faiha Diabetes Endocrine and Metabolism Center (FDEMC)

Basra, 61001, Iraq

Location

Related Publications (1)

• Hashim SA, Mohd Yusof BN, Abu Saad H, Ismail S, Hamdy O, Mansour AA. Effectiveness of simplified diabetes nutrition education on glycemic control and other diabetes-related outcomes in patients with type 2 diabetes mellitus. Clin Nutr ESPEN. 2021 Oct;45:141-149. doi: 10.1016/j.clnesp.2021.07.024. Epub 2021 Aug 3.

  PMID: 34620310 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dr. Barakatun-Nisak M Yusof, PhD

  Universiti Putra Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutritionist

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: June 9, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 2, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)