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IRCT20180124038497N1 IRCT 2018-03-15 Universiti Putra Malaysia Lifestyle Modification Intervention to reduce blood pressure among Pre-Hypertensive patients in Maran, Pahang LMIPHPT Lifestyle Modification Intervention to reduce blood pressure among Pre-Hypertensive patients in Maran, Pahang 2018-03-01 anticipated 408 Complete https://irct.ir/trial/29251 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of randomization will be the randomized block design using computer randomization plan generator. Block will be created to assign numbers equally to each group assign the block. The block size will be 2 in which we can make 2 possible sequences of AB and BA. Allocation sequence and concealment will be conducted by the representative from Maran District Health Office who is not involved in the research. Allocation concealment will be by using a sealed envelopes into which is is the treatment group A with lifestyle modification intervention and treatment group B without lifestyle modification intervention. A representative from Maran District Health Offie who is not involved in the research will distribute and open the envelope. 0 (exploratory trials) Pre-hypertension. Intervention 1: The intervention will be a Lifestyle modification intervention on blood pressure among pre-hypertensive patients module that will assert the information on risk factors of pre-hypertension and effects of unhealthy diet, smoking, physical inactivity and benefits of healthy diet. It will also include motivation to follow a healthy lifestyle to prevent hypertension. There will also be behavioural skills on following a healthy lifestyle to prevent hypertension. The IMB Model asserts that health-related information, motivation and behavioural skills are fundamental determinants of performance of health behaviours. To the extent that individuals are well informed, motivated to act and possess the requisite behavioural skills for effective actions, they will likely to initiate and maintain health-promoting behaviours and to experience positive health outcomes. The IMB approach to understanding and promoting health behaviour specifies a set of generalizable operations for constructing, implementing, and evaluating health promotion interventions for specific populations and health promotion behaviours of interest.Intervention will be delivered over a period of 2 months that will include two parts which are the half day health intervention session and the whatsapp session. There will be two half day health intervention session in which the second half day health intervention session will be conducted 2 weeks after conclusion of the 1st half day health intervention session and that both session will be in the same month. The second month will be second part of the intervention which is the serial whatsapp delivery of health messages for a total duration of one month (15 messages every 2 days).During the first half day session, group of 30 to 40 will watch a video presentation on pre-hypertension, risk factors, complication and prevention of pre-hypertension. This video presentation address the information component of the Information Motivation and Behavioural Skills module. The video presentation will be in a DVD format and will be 10 minutes in duration. The video preparation will be prepared by the researcher and the health education committee of Maran district Health Office. The group of 30 to 40 participants will later be given a lecture to address the aspect of personal motivation to follow a healthy lifestyle. This lecture will address the motivation component of the Information, Motivation and Behavioural Skills module. The lecture will be prepared by the researcher and be delivered by the researcher himself. Duration of the lecture will be around 30 minutes. The group of 30 to 40 will later be broken up into smaller group of 8 to 10 (4 groups). The 4 groups will move around four booths with each session at each booth lasting 30 minutes. The 4 booths include a) understanding healthy diet, food calorie and reading food label b) recording height, weight and body mass index c) importance of physical activity d) Importance of drinking water and recording of drinking water. During the second half day session, group of 30 to 40 will again watch the video presentation addressing the information component of the IMB module. The group of 30 to 40 participants will be given a lecture addressing the motivation component of the IMB module and the group of 30 to 40 will be broken up into smaller groups of 8 to 10 (4 groups). The 4 groups will move around four booths with each session at each booth lasting 20 minutes. The 4 booths include a) importance of healthy diet, food calorie, understanding food label, importance of drinking water b) sharing session of Quit Smoking clinic, and teaching skills on how to stop smoking and which include making plan to stop, picking a start date c) telling the family and friends for social support to stop smoking and alcohol d) identify your triggers, learn to de-stress, using an alternative and replacement to smoking and alcohol. The next part of the Intervention module is the Whatsapp messaging from educator to participant. The Whatsapp educator to participant ratio is one educator to 200 participants. The indication for the Whatsapp messaging is for the continuous motivation component of the research.The relevant qualification for educator or educationist are health care staff in the clinic employed by the Ministry of Health Malaysia , who is well trained in the non-communicable diseases prevention and have participated in previous health events that include health campaigns and KOSPEN events.On a summary, the frequency of number of information lectures is two and is given on two separate days. The mode of delivery of lectures are given on a group of 30 lecture. The frequency of motivation lectures will be two given on separate days. The group size of group discussions in the behavioural arm of the study is of ‘group of 6 to 10’ and that the discussions are guided by the educators. The frequency and number of behavioural group discussions is eight with four lectures on each separate days. The arm of study (Information, Motivation and Behavioural) occur simultaneously together. Strategy to monitor adherence to intervention include face to face adherence reminder session that will take place after patient had agreed to join the intervention during the recruitment phase. This session include importance of following study guidelines for adherence to following intervention module. Subsequent session will occur at the follow up visits during the intervention day. Participants will be asked about any problems of following the intervention at home, and that participants will have an opportunity to ask questions and key messages from the initial session will be reviewed as needed. Intervention 2: Control group will not receive the lifestyle modification intervention to reduce blood pressure among the pre-hypertensive patients. Control group will not be receiving any form of treatment for pre-hypertension. The control group will receive nothing in form of treatment or intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mohd Hafeez Bin Intiaz Hussein
84, Jln SS18/4E
Subang Jaya, Malaysia Malaysia 47500 +60 3-5638 4597 drhafeez84@gmail.com Universiti Putra Malaysia scientific Mohd Hafeez Bin Intiaz Hussein
84, Jln SS18/4E
Subang Jaya, Malaysia Malaysia 47500 +60 3-5638 4597 drhafeez84@gmail.com Universiti Putra Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Malaysia Blood pressure range between 120-139 mmHg Systolic and/or 80-89 mmHg diastolic Resident of Maran district, Pahang Own a working smartphone with installed Whatsapp application 18 years 59 years Male Not taking any anti-hypertensives Pregnant women Not physically impaired like amputated limbs Prevention N/A The intervention will be a Lifestyle modification intervention on blood pressure among pre-hypertensive patients module that will assert the information on risk factors of pre-hypertension and effects of unhealthy diet, smoking, physical inactivity and benefits of healthy diet. It will also include motivation to follow a healthy lifestyle to prevent hypertension. There will also be behavioural skills on following a healthy lifestyle to prevent hypertension. The IMB Model asserts that health-related information, motivation and behavioural skills are fundamental determinants of performance of health behaviours. To the extent that individuals are well informed, motivated to act and possess the requisite behavioural skills for effective actions, they will likely to initiate and maintain health-promoting behaviours and to experience positive health outcomes. The IMB approach to understanding and promoting health behaviour specifies a set of generalizable operations for constructing, implementing, and evaluating health promotion interventions for specific populations and health promotion behaviours of interest.Intervention will be delivered over a period of 2 months that will include two parts which are the half day health intervention session and the whatsapp session. There will be two half day health intervention session in which the second half day health intervention session will be conducted 2 weeks after conclusion of the 1st half day health intervention session and that both session will be in the same month. The second month will be second part of the intervention which is the serial whatsapp delivery of health messages for a total duration of one month (15 messages every 2 days).During the first half day session, group of 30 to 40 will watch a video presentation on pre-hypertension, risk factors, complication and prevention of pre-hypertension. This video presentation address the information component of the Information Motivation and Behavioural Skills module. The video presentation will be in a DVD format and will be 10 minutes in duration. The video preparation will be prepared by the researcher and the health education committee of Maran district Health Office. The group of 30 to 40 participants will later be given a lecture to address the aspect of personal motivation to follow a healthy lifestyle. This lecture will address the motivation component of the Information, Motivation and Behavioural Skills module. The lecture will be prepared by the researcher and be delivered by the researcher himself. Duration of the lecture will be around 30 minutes. The group of 30 to 40 will later be broken up into smaller group of 8 to 10 (4 groups). The 4 groups will move around four booths with each session at each booth lasting 30 minutes. The 4 booths include a) understanding healthy diet, food calorie and reading food label b) recording height, weight and body mass index c) importance of physical activity d) Importance of drinking water and recording of drinking water. During the second half day session, group of 30 to 40 will again watch the video presentation addressing the information component of the IMB module. The group of 30 to 40 participants will be given a lecture addressing the motivation component of the IMB module and the group of 30 to 40 will be broken up into smaller groups of 8 to 10 (4 groups). The 4 groups will move around four booths with each session at each booth lasting 20 minutes. The 4 booths include a) importance of healthy diet, food calorie, understanding food label, importance of drinking water b) sharing session of Quit Smoking clinic, and teaching skills on how to stop smoking and which include making plan to stop, picking a start date c) telling the family and friends for social support to stop smoking and alcohol d) identify your triggers, learn to de-stress, using an alternative and replacement to smoking and alcohol. The next part of the Intervention module is the Whatsapp messaging from educator to participant. The Whatsapp educator to participant ratio is one educator to 200 participants. The indication for the Whatsapp messaging is for the continuous motivation component of the research.The relevant qualification for educator or educationist are health care staff in the clinic employed by the Ministry of Health Malaysia , who is well trained in the non-communicable diseases prevention and have participated in previous health events that include health campaigns and KOSPEN events.On a summary, the frequency of number of information lectures is two and is given on two separate days. The mode of delivery of lectures are given on a group of 30 lecture. The frequency of motivation lectures will be two given on separate days. The group size of group discussions in the behavioural arm of the study is of ‘group of 6 to 10’ and that the discussions are guided by the educators. The frequency and number of behavioural group discussions is eight with four lectures on each separate days. The arm of study (Information, Motivation and Behavioural) occur simultaneously together. Strategy to monitor adherence to intervention include face to face adherence reminder session that will take place after patient had agreed to join the intervention during the recruitment phase. This session include importance of following study guidelines for adherence to following intervention module. Subsequent session will occur at the follow up visits during the intervention day. Participants will be asked about any problems of following the intervention at home, and that participants will have an opportunity to ask questions and key messages from the initial session will be reviewed as needed. Control group will not receive the lifestyle modification intervention to reduce blood pressure among the pre-hypertensive patients. Control group will not be receiving any form of treatment for pre-hypertension. The control group will receive nothing in form of treatment or intervention. A)Systolic Blood Pressure (mmHg) three months post intervention as compared to baseline. b) Diastolic Blood Pressure (mmHg) three months post intervention as compared to baseline. Timepoint: Before intervention and 3 months post intervention. Method of measurement: Blood pressure will be measured using a sphygmomanometer. Information, motivation and behavioural skills score on lifestyle modification (physical activity, healthy diet, smoking and alcohol). Timepoint: Before intervention and 3 months post intervention. Method of measurement: Questionnaire consisted of questions related to the Information and motivation to follow a healthy lifestyle to reduce pre-hypertension. For this include several sub-sections that include: a. Information on pre-hypertension b) Individual and social motivation related to pre-hypertension c. Behavioural skills on reducing pre-hypertension. Universiti Putra Malaysia Approved 2017-06-08 Medical Research and Ethics Committee Jalan rumah sakit, Bangsar Kuala Lumpur Kuala Lumpur Malaysia