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

NCT05746000 | Unknown

• 1 other identifier: My Smart Sugar Study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (16)

• Weight, height and Body Mass Index (BMI)

  At baseline and week-12 of the intervention

• Waist circumference, hip circumference and waist-to-hip ratio

  At baseline and week-12 of the intervention

• Dietary intake

  At baseline, week-4, week-8 and week-12 of the intervention.

• Dietary sugar intake

  At baseline and week-12 of the intervention.

• Eating behaviour

  At baseline and week-12 of the intervention

Study Arms (2)

Control Group

OTHER

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

Behavioral: Control Group (CG)

Intervention Group

OTHER

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

Behavioral: Intervention Group (IG)

Interventions

Intervention Group (IG) BEHAVIORAL

Three individual diet counselling that includes sugar calculation (sugar exchange) (60 minutes per session) at baseline, week-4 and week-8.

Intervention Group

Control Group (CG) BEHAVIORAL

Three individual diet counselling (60 minutes per session) at baseline, week-4 and week-8.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Barakatun-Nisak Mohd Yusof, PhD

CONTACT

0389472524; bnisak@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 27, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)