Nutrition Education Intervention for Adults With Type 2 Diabetes Receiving Outpatient Services at a Teaching Tertiary Hospital in Tshwane District
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c levels (HbA1c)
研究概览
简要总结
Aim: To implement a nutrition education programme (intervention) for adults with type 2 diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital setting in South Africa and to evaluate the programme's effectiveness on dietary behaviours, clinical status and selected potential behaviour mediators.
Participants and setting: T2DM adults (40-70 years) and at least one year of living with diabetes and poorly controlled diabetes (HbA1c ≥ 8%). The study setting is the outpatient clinic of a tertiary teaching hospital in Tshwane District (Pretoria), South Africa.
Intervention: The intervention will employ a randomised control design with two parallel groups (intervention & control). A total sample of 140 T2DM patients (70 per group) will be needed to detect a 0.5 % change in HbA1c (SD of 1.0 and a power of 80%) at six month and allowing a 10% attrition rate. The intervention is one-year long with the following components: 7-monthly group education sessions; 2 bi-monthly group follow-up sessions at the hospital till one year; participants' workbook for goal setting activities and education materials (pamphlet and wall/fridge poster) for the intervention group. The control group will receive the same education materials with no other education encounters. Both groups will continue with usual care at the diabetes outpatient clinic of the hospital. The education will be offered face to face, will utilize teaching aids including coloured posters and will incorporate interactive group activities and demonstrations. The main facilitator is a qualified dietitian.
Outcomes: Outcomes will be assessed at 6-and 12 months for both groups with the six month being the primary outcome. Outcomes will include clinical [HbA1c (primary outcome), BMI, blood pressure and full lipid profile); dietary behaviours (energy intake, starchy food servings, vegetable and fruits intake, macronutrient intake and their distribution to energy, fibre, meal pattern) and selected potential mediators of behavior (diabetes knowledge and diabetes management self- efficacy).
It is hypothesized that the intervention will lower the HbA1c levels by at least 0.5% at six months and the levels will be significantly lower in the intervention group compared with the control group, and the significantly lower levels will be sustained at 12 months in the intervention group.
详细描述
Aim of the study: To implement a nutrition education program (intervention) for adults with type 2 diabetes mellitus (T2DM) adapted from a primary health care setting to a tertiary hospital setting in South Africa and to evaluate the program's effectiveness on dietary behaviors, clinical status and selected potential behavior mediators.
General objectives
• The implementation of the adapted nutrition education program (NEP) at the diabetes outpatient clinic of a tertiary teaching hospital
• The evaluation of the program's effectiveness at six and 12 months on the following outcomes: (i) clinical status: Hemoglobin A1c (HbA1c) (primary outcome), BMI, blood pressure and lipid profile (ii) dietary behaviors (energy intake, starchy food servings, vegetable and fruits intake, macronutrient intake and their distribution to energy as a measure of meal balance, fiber and legume intake) (iii) potential behavior mediators (diabetes knowledge, diabetes management self-efficacy).
Primary outcome objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The health professionals (physicians, dietitians, nursing professionals) who serve the patients will only know the patient is participating in the study through a sticker on the medical records but they will not know the treatment allocation (group). Outcome assessors for biochemical parameters will not know the patient allocation as the assessments for the parameters are done alongside other routine assessments. Furthermore, they do not have the information that there are different patient groups
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type diabetes mellitus, poorly controlled (HbA1c > % 8), at least one year living with diabetes, without serious complications, mobile, regular attendance of diabetes clinic, not on full time employment, not planning to leave study site in the next one year.
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Nutrition education (group inclusive of education materials)
干预措施: Nutrition education (Behavioral)
Control group
Only receives education materials
结局指标
主要结局
Hemoglobin A1c levels (HbA1c)
时间窗: 6 months and 12 months
% change
次要结局
- Diabetes management self-efficacy(6 months and 12 months)
- Total cholesterol(6 months and 12 months)
- HDL-cholesterol(6 months and 12 months)
- Dietary fibre intake(6 months and 12 months)
- Triglycerides(6 months and 12 months)
- Hemoglobin A1c targets(6 months and 12 months)
- Starchy foods intake(6 months and 12 months)
- Body mass index (BMI)(6 months and 12 mo nths)
- LDL-cholesterol(6 months and 12 months)
- Dietary energy intake(6 months and 12 months)
- Vegetables and fruits intake(6 months and 12 months)
- Dietary behaviours(6 months and 12 months)
- Diabetes knowledge(6 months and 12 months)
研究者
Jane Muchiri
Principal Investigator
University of Pretoria