Reducing Salt and Sugar in Campus Foods: A Malaysian Study
NCT Number: NCT06473038
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiovascular Diseases
Interventions: OTHER: Reduction in Salt and Sugar|DEVICE: The potentiometer|DEVICE: Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)
Sponsor: Sunway University
Collaborators: Universiti Putra Malaysia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-07-01
Completion Date: 2026-12-31

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.

Primary Outcome Measures: Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community, Firstly, understanding the community's Knowledge, Attitude, and Practice can provide baseline data on the level of awareness regarding the health implications. Addressing misconceptions and promoting healthier dietary choices. Also assessing attitudes towards reduction provides insight into the community's readiness to embrace dietary changes.

The online validated questionnaire will assess:

1. Socio-demographic and lifestyle factors - questions such as age, gender, ethnicity, medical history, smoking and alcohol-drinking practices
2. Knowledge, Attitude, and Practice towards dietary salt and sugar intakes, and diabetes
3. Barriers and enablers for salt reduction

Target sample size of 1000 participants is set to consider mid-study drop-outs., Baseline|Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (canteen staff), Food providers' understanding of the importance of salt and sugar reduction directly influences the choices they make in the kitchen.

The online validated questionnaire will assess:

1. Knowledge, Attitude, and Practice towards salt and sugar usage in food preparation (including on campus) and in dietary intake
2. Perception, barriers and enablers for salt reduction during food preparation on campus

The targeted number of participants is around 50 people., baseline|Part 3 Study A: Interventional study on salt and sugar reduction of selected foods sold on campus (students and staff ), Selected samples of food sold on campus will be analysed for their sodium and sugar contents at baseline and also 3 months after the intervention of salt and sugar reduction. This will be performed using dry ashing method, followed by flame atomic absorption spectrometry (FAAS) at the Department of Nutrition, Universiti Putra Malaysia.

Scale Title: Sodium Content Determination Scale Range: 0 to 100 milligrams per kilogram (mg/kg) Interpretation: Higher scores indicate higher levels of sodium content, which may be considered a worse outcome in the context of reducing sodium intake.

targeted 5 food samples per vendor for 17 vendors - will yield a total number of 170 samples., baseline and 3 months after invention|Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Blood Pressure), Clinical measurements indicative of vascular health namely systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate will be taken using an automated blood pressure monitor (HEM- 7121, Omron, Japan) after the subjects have rested for 5 min. Measurement units: millimeters of mercury (mmHg), at three timepoints - at the start of the study, after 3 months and after 6 months|Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Wasit to Hip ratio), The height, waist and hip circumferences will be measured using a measuring tape and waist-hip ratio (WHR) will be calculated by dividing waist circumference by hip circumference. Measurement units: cm/inches, at three timepoints - at the start of the study, after 3 months and after 6 months|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), A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to determine body mass index (BMI) Measurement units = kg/m2 , total body fat (TBF) = kg/m 2.

The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) are ≥23 kg/m 2 , ≥25 kg/m 2, at three timepoints - at the start of the study, after 3 months and after 6 months|Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Fats), A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to measure visceral fat (VF) measurement unit = %, subcutaneous fat (SF) measurement unit = %, skeletal muscle percentage (SM) measurement unit = %

The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) 20% (males) or 30%, at three timepoints - at the start of the study, after 3 months and after 6 months|Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Resting Metabolic Rate), A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will measure resting metabolic rate, measurement unit = kcal/day.

The cut-off points for overweight, obesity, overall adiposity (TBF), and central adiposity (WHR) 0.90 (males) or 0.85 (females), at three timepoints - at the start of the study, after 3 months and after 6 months
Secondary Outcome Measures: Part 3 Study B: Assessment of saltiness intensity perception, Completed two rating scales assessing the intensity of saltiness of the selected foods sold on campus they perceived (hereafter referred to as 'intensity perception'), and the extent to which they liked or disliked this level of saltiness of the selected foods sold on campus (hereafter referred to as 'pleasantness rating'). The perceived saltiness intensity will be measured by using the generalised Labelled Magnitude Scale (gLMS) (8) where the participants will be asked to make a horizontal marking on the paper versions of it. A 100 mm scale was constructed with six different descriptors which were ''barely detectable'',''weak'', ''moderate'', ''strong'', ''very strong'' and ''strongest imaginable sensation of any kind'' were spaced at 1.4 mm, 6 mm, 17 mm, 35 mm, 53 mm, and 100 mm, respectively., baseline and 3 months after invention|Part 3 Study B: Assessment of pleasantness, For pleasantness, the Labelled Affective Magnitude (LAM) scale (9) will be used. It is a 100 mm scale that is constructed with 11 different levels - ''greatest imaginable disliking'' (0 mm), ''dislike extremely''(12 mm), ''dislike very much'' (22 mm), ''dislike moderately''(34 mm), ''dislike slightly'' (45 mm), ''neither like or dislike''(50 mm), ''like slightly'' (56 mm), ''like moderately'' (68 mm), ''like very much'' (78 mm), ''like extremely'' (87 mm), ''greatest imaginable liking'' (100 mm)., baseline and 3 months after invention|Part 3 Study B: Urine analysis of salt and sugar reduction of selected foods sold on campus, Accessing the urine electrolytes (sodium, potassium, chloride) and creatinine will be measured using the potentiometry method (Alinity Abbott). Intervention and control participants will provide two spot urine samples - first morning void and last void in the evening before leaving campus. This will yield a total of 300 × 2 × 3 = 1800 samples.

Sodium: Minimum value: 0 millimoles per liter (mmol/L), Maximum value: 200 mmol/L Potassium: Minimum value: 0 mmol/L, Maximum value: 20 mmol/L Chloride: Minimum value: 0 mmol/L, Maximum value: 200 mmol/L Creatinine: Minimum value: 0 milligrams per deciliter (mg/dL), Maximum value: 500 mg/dL

Interpretation:

Higher scores for urine electrolytes could be associated with different health conditions or dietary factors. Higher levels may imply a worse outcome., at three timepoints - at the start of the study, after 3 months and after 6 months|Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community, For pleasantness, the Labelled Affective Magnitude (LAM) scale (9) will be used. It is a 100 mm scale that is constructed with 11 different levels - ''greatest imaginable disliking'' (0 mm), ''dislike extremely''(12 mm), ''dislike very much'' (22 mm), ''dislike moderately''(34 mm), ''dislike slightly'' (45 mm), ''neither like or dislike''(50 mm), ''like slightly'' (56 mm), ''like moderately'' (68 mm), ''like very much'' (78 mm), ''like extremely'' (87 mm), ''greatest imaginable liking'' (100 mm)., baseline