Effectiveness of Nutrition Education Intervention on Glycemic Control (HbA1c)

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

Interventions

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.

Sponsors & Collaborators

• Universiti Putra Malaysia

  lead OTHER

Principal Investigators

• Dr. Barakatun-Nisak M Yusof, PhD · Universiti Putra Malaysia

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-06-09

Primary Completion

2019-12-01

Completion

2020-02-02

Countries

• Iraq

Study Locations