A Nutrition Education Module to Modify Sugar Consumptions Among Individuals With Cardio Metabolic Risks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of subjects in the intervention group who take up the intervention
研究概览
简要总结
The goal of this feasibility study is to assess the feasibility of a nutrition education module in modifying sugar consumption among individuals with cardiometabolic risk. The main questions it aims to answer are:
- Is the nutrition education (focusing on modifying sugars intake) intervention feasible to individuals with cardiometabolic risk?
- Can the intervention be delivered as planned and works as intended?
- What are the experiences, perspective and barriers of individuals with cardiometabolic risk when receiving the nutrition education intervention?
- Is the nutrition education intervention efficient in modifying the eating behaviour including the sugar consumption among individuals with cardiometabolic risk?
Participants in the Control Group and Intervention Group will attend three standard diet counselling, with additional sugar education for the Intervention Group.
详细描述
This study aims to assess the feasibility of a nutrition education module in modifying sugar consumption among individuals with cardiometabolic risk. This feasibility study will recruit patients from the Teaching Hospital of Universiti Putra Malaysia. Subjects' selection will be based on the inclusion and exclusion criteria of the study. This is a three-month feasibility study. Participants will be randomly assigned into two groups (Control and Intervention Groups). Participants in the Control Group will attend three standard diet counselling at baseline, week-4, and week-8. Participants in the Intervention Group will also attend three individual diet counselling and will be educated about sugar calculation (sugar exchange).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malaysian citizen
- •patients in Teaching Hospital of Universiti Putra Malaysia
- •aged 18-65 years old;
- •able to read, write and communicate either in Malay or English
- •education level of secondary school and above
- •able to use computer or gadgets (self-reported) with internet access at home
- •presence with cardiometabolic risk, defines as at least any three out of five risk factors based on:-
- •waist circumference (men: ≥90cm, women: ≥80 cm) or;
- •blood pressure (≥130/85 mmHg) or;
- •having diabetes mellitus or fasting blood sugar (≥5.6mmol/L) or;
- •triglyceride (≥1.7 mmol/L) or;
- •high-density lipoprotein (men: <1.03 mmol/L, women: <1.3 mmol/L)
- •If on medication, on stabilised dose for at least 2 months before recruitment to the study
- •Daily free sugar intake ≥5% of the daily energy intake
排除标准
- •Diagnosed with mental illness (depression, bipolar disorder, schizophrenia, dementia)
- •Uncontrolled type 2 diabetes defines as HbA1c of more than 8% or hypertriglyceridemia of >10 mmol/L
- •Presence of chronic diseases-related complications such as liver disease or stage 3 chronic kidney disease
- •Reported abnormal thyroid-stimulating hormones
- •On cancer therapy
- •Having lower limb disabilities
- •Breastfeeding, pregnancy, or the desire to become pregnant in the next 3 months
结局指标
主要结局
Proportion of subjects in the intervention group who take up the intervention
时间窗: At baseline of the intervention. All subjects who attend the intervention at baseline will be determined.
This can be determined by dividing the subjects the intervention group who take up the intervention by the number of subjects who are randomly assigned to the intervention group.
Proportion of eligible potential candidates who agree to participate in the study
时间窗: At screening period. All subjects who agree to participate in the intervention will be determined.
This can be determined by dividing the number of potential patients who agree to participate in the study by the total number of eligible patients in the patient lists.
Proportion of subjects who withdraw from the study or are lost to follow-up
时间窗: Three months of the intervention. All subjects who withdraw from the study or are lost to follow-up throughout the three months intervention will be determined.
This can be determined by dividing the subjects who withdraw from the study or are lost to follow-up throughout the intervention by the total number of subjects who participate in the study at baseline.
次要结局
- Dietary intake(At baseline, week-4, week-8 and week-12 of the intervention.)
- Eating behaviour(At baseline and week-12 of the intervention)
- Physical activity level(At baseline and week-12 of the intervention)
- Knowledge level(At baseline and week-12 of the intervention)
- Fasting blood glucose(At baseline and week-12 of the intervention)
- Insulin level(At baseline and week-12 of the intervention)
- Waist circumference, hip circumference and waist-to-hip ratio(At baseline and week-12 of the intervention)
- Dose received (what participants received)(At week-12 of the intervention)
- Weight, height and Body Mass Index (BMI)(At baseline and week-12 of the intervention)
- Health belief(At baseline and week-12 of the intervention)
- Blood pressure(At baseline and week-12 of the intervention)
- Triglyceride(At baseline and week-12 of the intervention)
- Reach (participation rate)(At baseline, week-4, week-8 and week-12 of the intervention)
- Dietary sugar intake(At baseline and week-12 of the intervention.)
- LDL-cholesterol(At baseline and week-12 of the intervention)
- Fidelity (quality of the program delivered)(At baseline, week-4, week-8 and week-12 of the intervention)
研究者
Barakatun Nisak Bt Mohd Yusof
Principal Investigator
Universiti Putra Malaysia