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NCT05746000
A Nutrition Education Module to Modify Sugar Consumptions Among Individuals With Cardio Metabolic Risks
Conditions: Cardiometabolic Syndrome
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 60
Sponsor: Universiti Putra Malaysia
Location: Malaysia
Summary
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.
Eligibility 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 feedingMental health statusDaily total sugar intakeInclusion Criteria:Malaysian citizenpatients in Teaching Hospital of Universiti Putra Malaysiaaged 18-65 years old;able to read, write and communicate either in Malay or Englisheducation level of secondary school and aboveable to use computer or gadgets (self-reported) with internet access at homepresence 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 studyDaily free sugar intake ≥5% of the daily energy intakeExclusion 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/LPresence of chronic diseases-related complications such as liver disease or stage 3 chronic kidney diseaseReported abnormal thyroid-stimulating hormonesOn cancer therapyHaving lower limb disabilitiesBreastfeeding, pregnancy, or the desire to become pregnant in the next 3 months
Source: ClinicalTrials.gov (NCT05746000). StuddyBuddy aggregates publicly available trial information.