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

Cardiometabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05746000
• Other study ID #: My Smart Sugar Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Universiti Putra Malaysia
• Contact: Barakatun-Nisak Mohd Yusof, PhD
• Phone: 0389472524
• Email: bnisak[@]upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome

Intervention

Behavioral:
• Intervention Group (IG)
Three individual diet counselling that includes sugar calculation (sugar exchange) (60 minutes per session) at baseline, week-4 and week-8.
• Control Group (CG)
Three individual diet counselling (60 minutes per session) at baseline, week-4 and week-8.

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible potential candidates who agree to participate in the study	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.	At screening period. All subjects who agree to participate in the intervention will be determined.
Primary	Proportion of subjects in the intervention group who take up the intervention	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.	At baseline of the intervention. All subjects who attend the intervention at baseline will be determined.
Primary	Proportion of subjects who withdraw from the study or are lost to follow-up	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.	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	Weight, height and Body Mass Index (BMI)	Weight (kilograms) and height (meters) will be combined to report BMI (kg/m2). BMI will be calculated using formula [weight in kilograms/ (height in meters)2] and cut-off point for normal BMI (18.5-24.9 kg/m2) will be used.	At baseline and week-12 of the intervention
Secondary	Waist circumference, hip circumference and waist-to-hip ratio	Waist (centimeters) and hip circumference (centimeters) will be combined to report waist-to-hip ratio. Waist-to-hip ratio will be calculated using formula (waist circumference in cm/hip circumference in cm).	At baseline and week-12 of the intervention
Secondary	Dietary intake	A 3-day Food Record will be used to determine the dietary intake.	At baseline, week-4, week-8 and week-12 of the intervention.
Secondary	Dietary sugar intake	A semi-quantitative Food Frequency Questionnaire of added sugar intake will be used to determine the dietary sugar intake.	At baseline and week-12 of the intervention.
Secondary	Eating behaviour	Eating behaviour will be determined using the Dutch Eating Behaviour Questionnaire (DEBQ), which will be evaluated based on a Likert scale with a scoring system identified as: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, and 5 = very often.	At baseline and week-12 of the intervention
Secondary	Health belief	Health belief level will be determined using a Health Belief Model questionnaire, which will be evaluated based on a five Likert scale where the lowest score refers to strongly disagree, followed by disagree, neutral, agree and strongly agree.	At baseline and week-12 of the intervention
Secondary	Physical activity level	Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ). And the level will be categorised as low, moderate or high.	At baseline and week-12 of the intervention
Secondary	Knowledge level	Knowledge level of healthy diet and sugar will be determined using the questions adapted from the Knowledge Assessment Questionnaire.	At baseline and week-12 of the intervention
Secondary	Blood pressure	Blood pressure will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.	At baseline and week-12 of the intervention
Secondary	Fasting blood glucose	Fasting blood glucose will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.	At baseline and week-12 of the intervention
Secondary	Triglyceride	Triglyceride level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.	At baseline and week-12 of the intervention
Secondary	LDL-cholesterol	LDL-cholesterol level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.	At baseline and week-12 of the intervention
Secondary	Insulin level	Insulin level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.	At baseline and week-12 of the intervention
Secondary	Reach (participation rate)	The participation rate will be determined by dividing the number of subjects who attend the session by the total number of subjects in the study.	At baseline, week-4, week-8 and week-12 of the intervention
Secondary	Fidelity (quality of the program delivered)	It will be measured based on observation and test account. For the diet counselling sessions, a score will be calculated to reflect the proportion of intended sessions that are delivered as scheduled. Also, a seven-item form will be used to assess whether the intended content of diet counselling is delivered. A test account will be used to monitor the message reminders received by the participants.	At baseline, week-4, week-8 and week-12 of the intervention
Secondary	Dose received (what participants received)	A self-reported evaluation survey and semi-structured interview will be conducted to measure the dose received. The participants will complete an evaluation survey immediately after the intervention to assess the usefulness and satisfaction of the intervention. A semi-structured interview will be conducted to determine the usefulness of intervention components, barriers to participation, and suggestions for improvements.	At week-12 of the intervention