Intermittent Fasting Towards Elevated Blood Pressure
Condition: Intermittent Fasting; Elevated Blood Pressure
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To date, the prevalence of Hypertension (HPT) is getting increase worldwide. This situation
      is contributed mostly by the Lower-Income Countries (LIC) and Lower-Middle-Income Countries
      (LMICs) include Asians. Elevated Blood Pressure (EBP) in the early phase is often unrealized
      before developing to HPT, leading to several diseases in terms of cardiovascular diseases
      (CVDs). In preventing EBP, the European Society of Cardiology in 2017 classifies blood
      pressure into three groups; normal, pre-hypertension, and hypertensive crisis. People in the
      normal phase with the high-normal line are classified into EBP. If this group is determined
      and controlled, they will further keep in normal blood pressure. Contrarily, they are
      experiencing the next phase of HPT.

      Like other Asian countries, Indonesia was experiencing an extreme prevalence of HPT, and
      Aceh, which is one of the provinces in Indonesia has a very high prevalence of HPT as well
      (20% increment from 2013-2018), is estimated to equal to the EBP prevalence. Despite many
      promotive and preventive interventions confirmed to decrease HPT, early screening has been
      convinced to recover the HPT in Indonesia. However, the HPT prevalence was examined steadily
      increasing. Intermittent fasting (IF) is recognized as a new method in decreasing metabolic
      factors based on several types of research currently. Therefore, the investigators are
      studying the effectiveness of intermittent fasting on people with EBP. Conducting healthy
      lifestyle intervention that is inexpensive, doable, and easily accessible, would be a new
      method for controlling EBP.
    

Detailed description: 
      This trial aims to evaluate the effectiveness of three months intermittent fasting
      intervention followed by three months maintenance phase in stabilizing blood pressure among
      the EBP group with the high-normal signal. This trial will conducts in Aceh, Indonesia.

      Trial procedure

        1. In the beginning, the researcher chooses the allocation group for either intervention or
           control group based on the potential number of workers from each department. Based on
           that, it was decided that the intervention group is the Governor's office, and the Aceh
           Besar regency secretariat is the control group.

        2. Letters of permission are submitted to both departments and continued by blood pressure
           screening once it is approved. Hence, the enumerators will screen all the workers. Each
           eligible participant (EBP 130-139/85-89 mm Hg and BMI ³ 25 kilograms/m2) will be invited
           to join blood pressure plus nutrition class on the day after, and fulfill the baseline
           characteristic questionnaire once they sign the informed consent. During the class, the
           researcher will describe the study procedure, study objective, process, monitoring,
           follow-up, methodology, risk and benefit, confidentiality, anonymity, and withdrawal
           from the study in both groups with the different context of intervention. Because of the
           covid-19 pandemic, all participants are allocated in a few small groups during baseline
           training.

        3. The participants will join complete anthropometric measurements and fulfill questions in
           the STEP instrument and GPAQ instrument. Four enumerators will assist the participants;
           however, they will be blinded to intervention assignment.

        4. The intervention group will undergo two fasting days and five ad libitum days during the
           intervention phase and continued to the maintenance phase. Otherwise, the control group
           will have a usual diet before the trial. Furthermore, both groups will have current
           exercise.

        5. Calculation of the actual sample size to detect effect size in the primary and secondary
           objectives of the project has been conducted. Sample selection techniques will be
           described further in the published paper.

        6. A mixed linear model will be applied to count the intervention effects (blood pressure,
           body weight, body mass index, waist circumference, and calorie intake), while a
           generalized estimating equation (GEE) will be used as well for categorical outcomes.
           Characteristics at baseline will be summarised by each arm using numbers and
           percentages, means and standard deviations or medians, and inter-quartile ranges where
           applicable.
    

Intervention name(s): Intermittent fasting; No intervention
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention group is required to perform intermittent fasting for two days. The intermittent fasting method for this group will mimic the Sunnah Muslim fasting; they are allowed to consume food and calorie water without restriction in between dusk and dawn. During the five ad libitum days, they are allowed to have a variety of foods and drinks. Subjects will be informed about healthy food choices; choosing low-fat meat and dairy options, increasing fruit and vegetable intake.; The control group will receive education training at the baseline as well, regarding blood pressure and nutrition. They will have usual exercise prior to the intervention. Furthermore, the group will have equal health education through health promotion leaflets which have been issued by the ministry of health.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This trial will have two groups; the intervention and the control group. Both groups will receive health education. Hence, the Intervention group will undergo two fasting days within the week from dusk to dawn, while the control group is doing the regular diet. No exercise control for both groups.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fasting; intermittent fasting; 5:2 diet; blood pressure; body mass index; body weight; waist circummference; calorie intake