Clinical trial NCT06473038: Reducing Salt and Sugar in Campus Foods: A Malaysian Study
Official title: An Interventional Study of Salt and Sugar Reduction in Foods Sold On a University/College Campus in Malaysia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Salt and Sugar Reduction
Knowledge, Attitude, and Practice (KAP)
Hypertension
Lead sponsor: Sunway University
Sponsor class: OTHER
Collaborators: name: Universiti Putra Malaysia
First posted: 2024-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who eat often foods sold on campus will be selected from the online validated questionnaire (part 1) in a randomized manner and they form the intervention group who will be eating the foods sold on campus that have reduced salt and sugar. Participants who do not eat often the food sold on campus will be the control group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to address the significant burden of cardiovascular disease in Malaysia, especially the high prevalence of hypertension with excessive salt and sugar intake. The study targets the university campus community, recognizing reliance on out-of-home food options and the potential impact of reducing salt and sugar in campus foods on overall health. The project aims to assess the knowledge, attitudes, and practices related to salt and sugar intake among students, staff, and campus canteen staff. Through a combination of surveys, dietary assessments, urine analysis, and body composition measurements, the study aims to generate valuable insights into effective strategies for reducing salt and sugar intake and improving cardiovascular health among the campus population.

Detailed description: Research Background:

Cardiovascular disease (CVD) represents a significant global health challenge, particularly in developing countries, where it stands among the primary causes of premature death and disability. In Malaysia, CVD remains the leading cause of premature mortality, with high blood pressure (BP) consistently identified as a major contributor. Despite efforts to address hypertension, the 2019 National Health and Morbidity Survey (NHMS) revealed a concerning 30% prevalence of hypertension among Malaysian adults aged 18 and above, with nearly two-thirds of hypertensive individuals remaining undiagnosed. Research has established that even a slight increase of 2mmHg in systolic blood pressure significantly elevates mortality rates from stroke and ischemic heart disease in adults.

The association between salt/sodium intake and BP has been well-documented, with reductions in salt/sodium intake shown to correlate with lower BP levels and decreased cardiovascular (CV) mortality. However, the mean salt intake in Malaysia significantly exceeds the WHO-recommended limit of \<5 gm/day, with the WHO setting a target to reduce population salt intake by 30% by 2025.

A notable trend in Malaysia is the increasing prevalence of dining out, particularly in urban areas and among young adults. This shift towards consuming meals away from home, including breakfast, underscores the importance of addressing salt and sugar intake in out-of-home foods. Studies conducted among Malaysians have highlighted a perception of high salt intake in the out-of-home food sector, with both consumers and food operators advocating for comprehensive salt reduction policies and improved awareness among stakeholders.

University campuses, including Sunway University and Sunway College, serve as critical environments where students and staff frequently rely on campus vendors for meals. Recognizing the impact of campus food environments on dietary habits, this study aims to assess the effects of salt and sugar reduction in foods sold on campus, targeting both the campus community and canteen staff. By investigating knowledge, attitudes, and practices (KAP) related to salt and sugar intake among students, staff, and canteen personnel, the study seeks to identify barriers and enablers to salt and sugar reduction and propose strategies for promoting healthier dietary habits.

Aims and Objectives:

The overarching goal of the study is to evaluate the effects of salt and sugar reduction in campus foods and address consumption patterns among Sunway University and Sunway College students and staff. The study comprises three main parts:

Part 1 involves assessing KAP on dietary salt and sugar intake among the campus community. Part 2 investigates KAP, perceptions, barriers, and enablers of salt and sugar reduction among campus canteen staff. Part 3 conducts a 6-month interventional study on salt and sugar reduction in foods sold on campus. Separated into Study A and Study B, where Study A mainly focuses on surveys and coming up with further recommendations. Study B is composed of utilizing urine samples and body composition measurements to assess the outcome of lowering sodium intake.

Study Methodology:

The study will involve surveying participants from the Sunway University and Sunway College community, including students, staff, and canteen personnel. Various instruments, including online questionnaires, urine analysis, anthropometric measurements, and dietary records, will be utilized to assess KAP, perceptions, and dietary habits related to salt and sugar intake.

Statistical analyses will be conducted using SPSS version 27, with comparisons of means and logistic regression analysis employed to determine factors associated with intention to reduce salt and sugar intake. The study aims to provide insights into the effectiveness of salt and sugar reduction interventions in campus food environments and their impact on cardiovascular health outcomes.

Eligibility criteria: Inclusion Criteria:

Part 1: KAP on dietary salt and sugar intake

1. Students and staff of Sunway University and Sunway College aged 18 years and above
2. Able to provide informed consent (verbal/written) to participate
3. Understands English

Part 2: KAP, Perception, Barriers and Enablers of Salt and Sugar Reduction among Campus Canteen Staff

1. Canteen staff that are involved in food preparation aged 18 years and above
2. Able to provide informed consent (verbal/written) to participate
3. Understands English

Part 3: An interventional study for 6 months will expose them to foods sold on campus that have reduced salt and sugar.

For intervention group

1. Individuals who eat on campus food for at least 3 meals per week
2. Consent to participate

For control group

1. Individuals who do not eat on campus food or for less than 3 meals per week
2. Consent to participate

Exclusion Criteria:

1. Individuals with acute illness, psychological or psychiatric conditions

Primary outcomes:
measure: Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community
timeFrame: Baseline
measure: Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (canteen staff)
timeFrame: baseline
measure: Part 3 Study A: Interventional study on salt and sugar reduction of selected foods sold on campus (students and staff )
timeFrame: baseline and 3 months after invention
measure: Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Blood Pressure)
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
measure: Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Wasit to Hip ratio)
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
measure: Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Body Mass Index and Total body fat)
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
measure: Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Fats)
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
measure: Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Resting Metabolic Rate)
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
Secondary outcomes:
measure: Part 3 Study B: Assessment of saltiness intensity perception
timeFrame: baseline and 3 months after invention
measure: Part 3 Study B: Assessment of pleasantness
timeFrame: baseline and 3 months after invention
measure: Part 3 Study B: Urine analysis of salt and sugar reduction of selected foods sold on campus
timeFrame: at three timepoints - at the start of the study, after 3 months and after 6 months
measure: Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Sunway University
name: Yook Chia Chin, MD
role: PRINCIPAL_INVESTIGATOR
References: