An interventional study of Intermittent Fasting and Healthy Plate in Intermittent Fasting and Obesity, sponsored by Ministry of Health, Malaysia. Completed at 3 sites in Malaysia. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-10.
Sponsored by Ministry of Health, Malaysia · Not applicable, Interventional, and Prevention
This study was a quasi-experimental study established to determine the cardio-metabolic, anthropometric, dietary intake and quality of life changes following combined Intermittent Fasting Healthy Plate and Healthy Plate interventions among overweight and obese civil servants.
BACKGROUND
Overweight and obesity among adults is a growing global public health threat and an essential risk factor for various non-communicable diseases. Although it is largely preventable, the worldwide prevalence of obesity nearly tripled from 1975 and 2016 and remained increasing each year. In 2016, more than 1.9 billion adults were overweight, and 650 million were obese. If this current trend continues, it is estimated that 2.7 billion and over 1 billion adults will be overweight and obese by 2025, respectively.
Since obesity occurs due to positive energy balance in the body, the strategies of preventing and treating obesity mainly focus on dietary modification and increasing physical activity. One form of calorie restriction dietary protocol is intermittent fasting (IF), which encompasses various eating diet plans that cycle between a period of fasting and non-fasting over a defined period to create a negative energy balance, hence inducing weight loss. Studies have shown that IF is effective in reducing body weight and improving metabolic outcome. Although the effects of wet IF have been well documented, the benefits of dry IF (except for Ramadan fasting) is not clearly indicated in previous studies. Dry IF is defined as complete fasting without food and fluid intake.
As portion size is a crucial determinant of energy intake, portion control by controlling the serving size is another practical method to reduce calorie intake and promote weight loss. This portion control method has been widely practised and studied worldwide, using different portion divisions depends on the culture and eating habits. Malaysia Healthy Plate, a portion control dietary plan, was created to translate the messages in Malaysia Dietary Guideline 2010 and the Malaysia Food Pyramid 2010. It is a visual tool that emphasises the quarter-quarter-half concept that provides a quick visual technique that helps ensure the intake of food is within the recommended guideline. Specifically, Malaysia Healthy Plate is a single-meal guide that divides the plate into a quarter plate of grains or grains products, a quarter plate of fish, poultry, meat or egg, and a half plate of fruits and vegetables.
While weight losses are reported in studies of conventional IF, the adaptive phenomenon of dry IF on Monday and Thursday on cardiometabolic and anthropometric outcomes is still unclear. Similarly, although the policy of Malaysia Healthy Plate has been widely practised and publicised since 2010, the effectiveness of this eating plan in improving cardiometabolic risks and promoting weight loss is still not well documented. Thus, this study aimed to determine the cardiometabolic, anthropometric, dietary intake and quality of life changes among overweight and obese civil servants following combined Intermittent Fasting and Healthy Plate (IFHP) and Healthy Plate (HP), and to explore the participants' experience throughout the study. The investigators want to investigate whether combining dry IF and HP diet protocol will improve those parameters compared to HP alone.
METHODS
This was a mixed-method quasi-experimental study that evaluates the effectiveness of IFHP and HP among overweight and obese adults. A total of 177 participants were recruited in this study, of which 91 was allocated in the IFHP group and 86 in the HP group. The intervention comprises two phases; supervised (12 weeks) and unsupervised (12 weeks). The data collection was conducted during baseline, after the supervised phase (at week 12), and after the unsupervised phase (at week 24). For each participant, serum and whole blood were collected for analysis. Data on socio-demographic, quality of life, physical activity and dietary intake were also obtained using questionnaires during data collection.
The sample size calculation was conducted using the Power and Sample Size Program. It was followed the rules required for the comparison of two groups (10). The sample size was estimated using the level of significance (α =0.05) and power of the study (1-β=0.80), minimum suggested difference (delta) of 5% weight loss that may be achieved under this intervention and the corresponding differences between groups (SD=10%). The minimum sample size required for the study is 64 participants. By considering 40% attrition, the required sample size for each arm is 90 participants. The total number of participants required for this study is 180.
Data Management
To ascertain that the data collection and record-keeping are conducted efficiently, the Data Collection Booklet was developed and assigned to each participant of this study. This booklet consists of five sections (Socio-demographic, Quality of Life, Physical Activity, Dietary Record and Anthropometry Measurements Sections) sorted into three parts representing each point of data collection; baseline, month three and month six. This booklet was used as a data collection tool to record responses and measurements of the participant during baseline and follow-ups.
Data recorded in the booklet was then entered into a database at the end of the study. The data cleaning procedure was conducted by crosschecking all the entered data in the database and booklet and exploring the data to detect any significant outliers that possibly resulted from measurement error or data entering.
Data Analysis
Analysis was conducted using the Statistical Package of Social Science (SPSS) software version 25 (IBM Corp, NY). Data for continuous variables were presented by mean ± standard deviation (SD) or median and interquartile range (IQR) (for non-normally distributed data). For categorical variables, frequencies were calculated and presented together with percentages. Variables were compared using the independent t-test or Mann-Whitney U test for continuous variables and the Chi-squared or Fisher's exact (n≤5 in any cell) test for categorical variables. All statistical tests were two-sided and used a significance level of p \<0.05. In further analysis, the repeated measures ANOVA will be used to compare the within and between groups changes of the outcomes.
333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.
This study's enrollment of 177 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.
Browse Intermittent Fasting studies →Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dry fasting from dawn to dusk for two days a week (Monday and Thursday) and Healthy Plate for the rest of the week. Female participants were discouraged from fasting during their menstruation period.
Other: Intermittent Fasting · Other: Healthy Plate
Practice the Healthy Plate concept in at least one meal every day
Other: Healthy Plate
During fasting day, no food or drink allowed from dawn to dusk
Also known as: Dry Intermittent Fasting
Quarter-quarter-half meal concept
Also known as: Malaysian Healthy Plate
Body weight changes
Body weight changes measured in kilogram
Time frame: Change from Baseline Body Weight at week 12
Body weight changes
Body weight changes measured in kilogram
Time frame: Change from Baseline Body Weight at week 24
Body mass index (BMI) changes
Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Time frame: Change from Baseline BMI at week 12
Body mass index (BMI) changes
Body mass index changes measured in kg/m\^2 (weight in kilograms, height in meters)
Time frame: Change from Baseline BMI at week 24
Waist-Hip Ratio (WHR) changes
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Time frame: Change from Baseline WHR at week 12
Waist-Hip Ratio (WHR) changes
WHR changes measured in centimeters (waist and hip circumference in centimeters)
Time frame: Change from Baseline WHR at week 24
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Time frame: Change from Baseline Body Fat Percentage at week 12
Body Fat Percentage changes
Body Fat Percentage changes measured in percentage
Time frame: Change from Baseline Body Fat Percentage at week 24
Body Fat Mass changes
Body Fat Mass changes measured in kilograms
Time frame: Change from Baseline Body Fat Mass at week 12
Body Fat Mass changes
Body Fat Mass changes measured in kilograms
Time frame: Change from Baseline Body Fat Mass at week 24
Fat Free Mass changes
Fat Free Mass changes measured in kilograms
Time frame: Change from Baseline Body Fat Mass at week 12
Fat Free Mass changes
Fat Free Mass changes measured in kilograms
Time frame: Change from Baseline Body Fat Mass at week 24
Systolic Blood Pressure changes
Systolic Blood Pressure changes measured in mmHg
Time frame: Change from Baseline Systolic Blood Pressure at week 12
Systolic Blood Pressure changes
Systolic Blood Pressure changes measured in mmHg
Time frame: Change from Baseline Systolic Blood Pressure at week 24
Diastolic Blood Pressure changes
Diastolic Blood Pressure changes measured in mmHg
Time frame: Change from Baseline Diastolic Blood Pressure at week 12
Diastolic Blood Pressure changes
Diastolic Blood Pressure changes measured in mmHg
Time frame: Change from Baseline Diastolic Blood Pressure at week 24
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Time frame: Change from Baseline Fasting Blood Glucose at week 12
Fasting Blood Glucose changes
Fasting Blood Glucose changes measured in mmol/L
Time frame: Change from Baseline Fasting Blood Glucose at week 24
2-hour Post Prandial Blood Glucose changes
2-hour Post Prandial changes measured in mmol/L
Time frame: Change from Baseline 2-hour Post Prandial at week 12
2-hour Post Prandial Blood Glucose changes
2-hour Post Prandial changes measured in mmol/L
Time frame: Change from Baseline 2-hour Post Prandial at week 24
HbA1c changes
HbA1c changes measured in percentage
Time frame: Change from Baseline HbA1c at week 12
HbA1c changes
HbA1c changes measured in percentage
Time frame: Change from Baseline HbA1c at week 24
Fasting Total Cholesterol changes
Fasting Total Cholesterol changes measured in mmol/L
Time frame: Change from Baseline Fasting Total Cholesterol at week 12
Fasting Total Cholesterol changes
Fasting Total Cholesterol changes measured in mmol/L
Time frame: Change from Baseline Fasting Total Cholesterol at week 24
Fasting Triglyceride changes
Fasting Triglyceride changes measured in mmol/L
Time frame: Change from Baseline Fasting Triglyceride at week 12
Fasting Triglyceride changes
Fasting Triglyceride changes measured in mmol/L
Time frame: Change from Baseline Fasting Triglyceride at week 24
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Fasting HDL-C measured in mmol/L
Time frame: Change from Baseline Fasting HDL-C at week 12
Fasting High-density Lipoprotein-Cholesterol (HDL-C) changes
Fasting HDL-C measured in mmol/L
Time frame: Change from Baseline Fasting HDL-C at week 24
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Fasting LDL-C measured in mmol/L
Time frame: Change from Baseline Fasting LDL-C at week 12
Fasting Low-density Lipoprotein-Cholesterol (LDL-C) changes
Fasting LDL-C measured in mmol/L
Time frame: Change from Baseline Fasting LDL-C at week 24
Fasting Insulin changes
Fasting Insulin measured in uU/ml
Time frame: Change from Baseline Fasting Insulin at week 12
Fasting Insulin changes
Fasting Insulin measured in uU/ml
Time frame: Change from Baseline Fasting Insulin at week 24
Quality of Life changes
Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire
Time frame: At baseline, week 12 and week 24
Dietary Intake changes
Dietary intake changes measured by Food Frequency Questionnaire (FFQ)
Time frame: At baseline, week 12 and week 24
Plan to share: No
Ran from Jun 2020 to primary completion in Apr 2021, 10 months.
Of 257 non-industry interventional studies with no phase under Intermittent Fasting, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's 10 months is below that.
Counting every sponsor, half of 263 studies reached it within 17 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Malaysia