A Nutrition Education Module to Modify Sugar Consumptions Among Individuals With Cardio Metabolic Risks

University of Putra Malaysia (UPM)

Status: Not yet enrolling

Conditions: Cardiometabolic Syndrome

Treatments: Behavioral: Control Group (CG); Behavioral: Intervention Group (IG)

Study type: Interventional

Funder types: Other

Identifiers

NCT05746000

My Smart Sugar Study

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Candidates will be screened for:

• Cardiometabolic risk factors (waist circumference, blood pressure, fasting blood glucose, triglyceride and high-density lipoprotein cholesterol)
• Pregnancy or breast feeding
• Mental health status
• Daily total sugar intake

Inclusion Criteria:

• 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:-

  1. waist circumference (men: ≥90cm, women: ≥80 cm) or;
  2. blood pressure (≥130/85 mmHg) or;
  3. having diabetes mellitus or fasting blood sugar (≥5.6mmol/L) or;
  4. triglyceride (≥1.7 mmol/L) or;
  5. 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Group

Other group

Description:

Participants in the control group will attend three standard diet counselling.

Treatment:

Behavioral: Control Group (CG)

Intervention Group

Other group

Description:

Participants in the intervention group will attend three individual diet counselling and will be educated about sugar calculation (sugar exchange).

Treatment:

Behavioral: Intervention Group (IG)