Intermittent Fasting Towards Elevated Blood Pressure
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|ClinicalTrials.gov Identifier: NCT04953650|
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : July 8, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Intermittent Fasting Elevated Blood Pressure||Behavioral: Intermittent fasting Other: No intervention||Not Applicable|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|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:||Single (Outcomes Assessor)|
|Masking Description:||The enumerators will help the researcher in data measurements; however, they will be blinded for the intervention.|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effectiveness of Intermittent Fasting Towards Elevated Blood Pressure Among Civil Servants in Aceh|
|Estimated Study Start Date :||July 16, 2021|
|Estimated Primary Completion Date :||January 16, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: intervention group
two fasting days and five ad-libitum days followed by usual exercise.
Behavioral: Intermittent fasting
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.
Sham Comparator: Control group
Usual diet and usual exercise prior to the intervention.
Other: No intervention
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.
- Blood pressure [ Time Frame: Baseline, 12 weeks and 24 weeks ]
Change from baseline systolic blood pressure and diastolic blood pressure at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.
The blood pressure is measured by Omron sphygmomanometer (Omron HEM 7130 LP, Kyoto, Japan).
- Body weight [ Time Frame: Baseline, 12 weeks and 24 weeks ]
Change from baseline body weight at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.
The body weight is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan)
- Body mass index [ Time Frame: Baseline, 12 weeks and 24 weeks ]
Change from baseline BMI at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.
The BMI is measured by weighing scale (Oserio Body fat monitor, Guozhong, Taiwan) and Stadiometer (Saga, Indonesia)
- Waist circumference [ Time Frame: Baseline, 12 weeks and 24 weeks ]
Change from baseline waist circumference at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.
The waist circumference is measured by tape line (China)
- Calorie intake [ Time Frame: Baseline, 12 weeks and 24 weeks ]
Change from baseline calorie intake at 12 weeks and 24 weeks (6 months) in participants with elevated blood pressure and BMI above is equal to 25 kilogram/m2.
The calorie intake is measured by three days food record form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04953650
|Contact: Dharina Baharuddin, BPH, MPHemail@example.com|
|Contact: Mas Ayu Said, MPH, PhDfirstname.lastname@example.org|
|Aceh Governor's Office and Aceh Besar regency secretariat|
|Banda Aceh, Aceh, Indonesia|
|Contact: Dharina Baharuddin, MPH +6285260963094 email@example.com|
|Principal Investigator:||Mas Ayu Said, MPH, PhD||University of Malaya|