Intermittent Fasting Among Overweight and Obese Civil Servants in Malaysia.
Condition: Intermittent Fasting; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Intermittent Fasting; Healthy Plate
Intervention type(s): Other; Other
Intervention description(s): During fasting day, no food or drink allowed from dawn to dusk; Quarter-quarter-half meal concept
Other intervention name(s): Dry Intermittent Fasting; Malaysian Healthy Plate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study applying mixed study method that consists of two parts: quantitative and qualitative. The quantitative part involved allocating participants into two intervention arms; combined Intermittent Fasting and Healthy Plate (IFHP) group and Healthy Plate (HP) group, and measuring the outcomes at baseline, 3-month and 6-month. On the other hand, the qualitative part aimed to explore the facilitators and barriers that enable or admonish the success of weight loss in the IFHP group through Focused Group Discussion that was conducted at month 6.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intermittent Fasting; Obesity; Overweight; Healthy Plate