| ObjectivesHypertension is a common chronic disease which poses severe disease burden to patients and society.Diet plays an important role in hypertension management.The majority of dietary behavior intervention for hypertensive patients at present is traditional health education.In recent years,with the development of mobile health technology,QQ and We Chat communication groups are used to guide patients’ dietary behaviors.However,the adherence or persistence of the dietary behavior is low.Data from multiple sources suggest that there is a great potential for personalized and precise dietary intervention in hypertensive patients.This study aims at developing and validating an effective,low cost and sustainable personalized dietary intervention package for hypertensives（PDIPH）.The specific research objectives include:（1）designing the PDIPHH;（2）developing a computer aid software to facilitate the PDIPH;（3）using a randomized controlled trial to implement and evaluate the efficacy of the PDIPH.MethodPDIPH was developed via: 1)collecting patients’ daily home measured blood pressure data through an smart electronic sphygmomanometer;2)collecting,through humanmachine joint counseling,data about patients’ past 24 hour dietary,difficulties and obstacles encountered in practicing dietary changes,and dietary knowledge,attitude and practice;3)developing a dietary intervention pathway and materials for hypertensive patients based on theoretical models and existing research evidences;4)generating a best intervention pathway and personalized intervention materials based on the data from steps 1)and 2),analysis model and computer aid software;5)implementing the PDIPH generated from step 4 through remote measures（text messages,phone calls,paper emails,voice sphygmomanometers,etc.）;6)repeating the above steps and keep the PDIPH ongoing.Computer aid software was designed using MyEclipse as the development platform,SQL Server 2008R2 as the data management tool,and JAVA as the programming language,the automatic communication platform provided by i FLYTEK as the interface for sending personalized messages.Randomized controlled trial was used to implement the PDIPH.Patients with hypertension in 48 administrative villages in 5 townships of Jieshou City were selected as the study subjects.The inclusion criteria of baseline survey were patient who: 1)had received intelligent voice sphygmomanometer for at least one year;2)was able to communicate;3)was willing to participate in this baseline survey and sign the informed consent form.The baseline survey began on July 10,2021 and lasted for 20 days.A questionnaire designed by our research team was used in the baseline survey,and trained investigators conducted a face-to-face questionnaire survey to collect data about social demographics,24-hour dietary intake,physical measurement indicators（e.g.,body height,weight）.After baseline recruitment,the 48 administrative villages were randomly assigned into intervention group and control group.Patients who had provided wrong phone number or unwilling to continue to participate in the intervention study were excluded from the intervention study.The intervention group implemented the PDIPH and the control group maintained the existing hypertension patient management.The intervention period was from August15,2021 to February 15,2022.For the endpoint evaluation,a questionnaire survey of the patients was conducted by means of human supervised machine interview.The evaluation measures included hypertension diet related KAP,diet behavior score and blood pressure.Multivariate regression model was used to explore the influencing factors of each dietary behavior,and t-test was used to compare the changes of each indicator between the intervention group and the control group and between baseline and endpoint.ResultsBaseline survey3005 patients were recruited at baseline with an average age of 65.4 years and more women than men（57.0% vs 43.0%）.Their average age of diagnosis and length of hypertension was 56.0 and 9.5 years respectively.Of all the recruited patients,93.7%were taking antihypertensive drugs.Their mean values of SBP and DBP were 136.8and 81.1 mmHg respectively.Their average dietary KAP scores were 0.87 ± 1.08,11.18±6.04 and 0.89±1.08 respectively.Their intake of starch,rice and flour food in the previous day was 1150 ml.The rate of did not eat vegetables,cereals,red meat,pickles,fat or fried food and fruits were 22.2%,80.7%,60.8%,96.3%,71.6% and67.2% respectively.Their scores of miscellaneous grain intake,fruit intake,pickle intake,fat intake,non-red meat protein intake,vegetable intake,energy intake and comprehensive dietary goal behavior were 0.70±1.52,1.28±2.00,0.18±0.86,1.08±1.85,2.12±2.78,2.74±1.96,5.92±1.58 and-0.02±1.32,respectively.Endpoint assessment81.0% of patients in the intervention group had received the personalized diet messages（including short messages broadcasted by the sphygmomanometer）.Among the patients who received messages,47.2% said that they "will exactly do what is recommended by the text messages",and 38.5% of the patients said that they “will sometimes do what is recommended by the text messages".83.0% of the patients in the intervention group had received regular feedback reports of blood pressure.53.1%of them said the feedback report was "greatly helpful",and 35.7% thought "somewhat helpful".After 6 months of PDIPH,the KAP score difference between baseline and endpoint in intervention group were 0.26 ± 0.68,1.03 ± 1.63 and 0.14 ± 0.72 respectively.In terms of dietary objective behavior: the vegetable intake score,multigrain intake score,calorie intake score,fat intake score and TDTBS in the intervention group all showed improvements.The increase in the above scores were1.6,1.3,0.18 and 4.0 times respectively than that of the control group,and the decrease in the calorie intake score was 1.7 times than that of the control group.The SBP and DBP in the intervention arm at the 6th month after intervention decreased by9.11 mmHg and 3.26 mmHg respectively from the baseline,and the SBP and DBP in the intervention group was 3.40 mmHg and 1.11 mmHg lower respectively than that in the control group.ConclusionsThe dietary behaviors in rural hypertensive patients are far from ideal,and continuous and more effective interventions are required.PDIPH has proved at least certain feasibility,acceptability and effectiveness and could be expanded. |
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