Clinical trial NCT05746000: A Nutrition Education Module to Modify Sugar Consumptions Among Individuals With Cardio Metabolic Risks
Official title: A Nutrition Education Module to Modify Sugar Consumptions Among Individuals With Cardio Metabolic Risks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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).

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 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

Primary outcomes:
measure: Proportion of eligible potential candidates who agree to participate in the study
timeFrame: At screening period. All subjects who agree to participate in the intervention will be determined.
measure: Proportion of subjects in the intervention group who take up the intervention
timeFrame: At baseline of the intervention. All subjects who attend the intervention at baseline will be determined.
measure: Proportion of subjects who withdraw from the study or are lost to follow-up
timeFrame: 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.
Secondary outcomes:
measure: Weight, height and Body Mass Index (BMI)
timeFrame: At baseline and week-12 of the intervention
measure: Waist circumference, hip circumference and waist-to-hip ratio
timeFrame: At baseline and week-12 of the intervention
measure: Dietary intake
timeFrame: At baseline, week-4, week-8 and week-12 of the intervention.
measure: Dietary sugar intake
timeFrame: At baseline and week-12 of the intervention.
measure: Eating behaviour
timeFrame: At baseline and week-12 of the intervention
measure: Health belief
timeFrame: At baseline and week-12 of the intervention
measure: Physical activity level
timeFrame: At baseline and week-12 of the intervention
measure: Knowledge level
timeFrame: At baseline and week-12 of the intervention
measure: Blood pressure
timeFrame: At baseline and week-12 of the intervention
measure: Fasting blood glucose
timeFrame: At baseline and week-12 of the intervention
measure: Triglyceride
timeFrame: At baseline and week-12 of the intervention
measure: LDL-cholesterol
timeFrame: At baseline and week-12 of the intervention
measure: Insulin level
timeFrame: At baseline and week-12 of the intervention
measure: Reach (participation rate)
timeFrame: At baseline, week-4, week-8 and week-12 of the intervention
measure: Fidelity (quality of the program delivered)
timeFrame: At baseline, week-4, week-8 and week-12 of the intervention
measure: Dose received (what participants received)
timeFrame: At week-12 of the intervention
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
References: