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

Primary Purpose

Cardiometabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Intervention Group (IG)
Control Group (CG)
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiometabolic Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:- 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 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

Sites / Locations

  • Universiti Putra Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control Group

Intervention Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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).
Dietary intake
A 3-day Food Record will be used to determine the dietary intake.
Dietary sugar intake
A semi-quantitative Food Frequency Questionnaire of added sugar intake will be used to determine the dietary sugar intake.
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.
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.
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.
Knowledge level
Knowledge level of healthy diet and sugar will be determined using the questions adapted from the Knowledge Assessment Questionnaire.
Blood pressure
Blood pressure will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Fasting blood glucose
Fasting blood glucose will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Triglyceride
Triglyceride level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
LDL-cholesterol
LDL-cholesterol level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Insulin level
Insulin level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
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.
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.
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.

Full Information

First Posted
February 6, 2023
Last Updated
February 16, 2023
Sponsor
Universiti Putra Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05746000
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
Participants in the control group will attend three standard diet counselling.
Arm Title
Intervention Group
Arm Type
Other
Arm Description
Participants in the intervention group will attend three individual diet counselling and will be educated about sugar calculation (sugar exchange).
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group (IG)
Intervention Description
Three individual diet counselling that includes sugar calculation (sugar exchange) (60 minutes per session) at baseline, week-4 and week-8.
Intervention Type
Behavioral
Intervention Name(s)
Control Group (CG)
Intervention Description
Three individual diet counselling (60 minutes per session) at baseline, week-4 and week-8.
Primary Outcome Measure Information:
Title
Proportion of eligible potential candidates who agree to participate in the study
Description
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.
Time Frame
At screening period. All subjects who agree to participate in the intervention will be determined.
Title
Proportion of subjects in the intervention group who take up the intervention
Description
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.
Time Frame
At baseline of the intervention. All subjects who attend the intervention at baseline will be determined.
Title
Proportion of subjects who withdraw from the study or are lost to follow-up
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Weight, height and Body Mass Index (BMI)
Description
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.
Time Frame
At baseline and week-12 of the intervention
Title
Waist circumference, hip circumference and waist-to-hip ratio
Description
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).
Time Frame
At baseline and week-12 of the intervention
Title
Dietary intake
Description
A 3-day Food Record will be used to determine the dietary intake.
Time Frame
At baseline, week-4, week-8 and week-12 of the intervention.
Title
Dietary sugar intake
Description
A semi-quantitative Food Frequency Questionnaire of added sugar intake will be used to determine the dietary sugar intake.
Time Frame
At baseline and week-12 of the intervention.
Title
Eating behaviour
Description
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.
Time Frame
At baseline and week-12 of the intervention
Title
Health belief
Description
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.
Time Frame
At baseline and week-12 of the intervention
Title
Physical activity level
Description
Physical activity level will be measured using International Physical Activity Questionnaire (IPAQ). And the level will be categorised as low, moderate or high.
Time Frame
At baseline and week-12 of the intervention
Title
Knowledge level
Description
Knowledge level of healthy diet and sugar will be determined using the questions adapted from the Knowledge Assessment Questionnaire.
Time Frame
At baseline and week-12 of the intervention
Title
Blood pressure
Description
Blood pressure will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Time Frame
At baseline and week-12 of the intervention
Title
Fasting blood glucose
Description
Fasting blood glucose will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Time Frame
At baseline and week-12 of the intervention
Title
Triglyceride
Description
Triglyceride level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Time Frame
At baseline and week-12 of the intervention
Title
LDL-cholesterol
Description
LDL-cholesterol level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Time Frame
At baseline and week-12 of the intervention
Title
Insulin level
Description
Insulin level will be obtained from subjects' record in the Teaching Hospital of Universiti Putra Malaysia.
Time Frame
At baseline and week-12 of the intervention
Title
Reach (participation rate)
Description
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.
Time Frame
At baseline, week-4, week-8 and week-12 of the intervention
Title
Fidelity (quality of the program delivered)
Description
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.
Time Frame
At baseline, week-4, week-8 and week-12 of the intervention
Title
Dose received (what participants received)
Description
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.
Time Frame
At week-12 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:- 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barakatun-Nisak Mohd Yusof, PhD
Phone
0389472524
Ext
2524
Email
bnisak@upm.edu.my
Facility Information:
Facility Name
Universiti Putra Malaysia
City
Serdang
State/Province
Selangor
ZIP/Postal Code
43400
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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