Dataset Information

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.

ABSTRACT:

Background

Strict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow.

Objective

To evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients.

Design

Randomized community intervention trial.

Participants

The control group comprised 967 patients who received standard antihypertensive drug intervention therapy from two communities, whereas the intervention group comprised 1945 patients who received antihypertensive drug and lifestyle intervention therapies from four communities in rural China.

Main measures

Data on lifestyle behaviors and BP measurements at baseline and 1-year follow-up were collected. A difference-in-difference logistic regression model was used to assess the effect of the intervention.

Key results

BP control after the 1-year intervention was better than that at baseline in both groups. The within-group change in BP control of 59.3% in the intervention group was much higher than the 25.2% change in the control group (P < 0.001). Along with the duration of the follow-up period, systolic and diastolic BP decreased rapidly in the early stages and then gradually after 6 months in the intervention group (P < 0.001). In the intervention group, drug therapy adherence was increased by 39.5% (from 48.1% at 1 month to 87.6% at 1 year) (P < 0.001), more in women (45.6%) than in men (31.2%; P < 0.001). The net effect of the lifestyle intervention improved the rate of BP control by 56.1% (70.8% for men and 44.7% for women). For all physiological and biochemical factors, such as body mass index, waist circumference, lipid metabolism, and glucose control, improvements were more significant in the behavioral intervention group than those in the control group (all P < 0.001).

Conclusion

The addition of lifestyle intervention by physicians or nurses helps control BP effectively and lowers BP better than usual care with antihypertensive drug therapy alone.

SUBMITTER: Xiao J

PROVIDER: S-EPMC7728841 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.

Xiao Jing J Ren Wen-Long WL Liang Yuan-Yuan YY Shen Huan H Gao Yue-Xia YX Chu Min-Jie MJ Li Zhou Z Wang Xiao-Jian XJ Zhang Zuo-Feng ZF Zhuang Xun X Yu Yong-Fu YF

Journal of general internal medicine 20201006 12

<h4>Background</h4>Strict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow.<h4>Objective</h4>To evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients.<h4>Design</h4>Randomized community intervention trial.<h4>Participants</h4>The control group comprised 967 patients who received standard antihypertensive drug intervention therapy from two communi ...[more]

PMID: 33021715

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Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.

Project description:BackgroundA behavioral lifestyle intervention program with goals of increasing physical activity (PA) and losing weight was shown to be efficacious for preventing type 2 diabetes and decreasing risk for cardiovascular disease in the U.S. Diabetes Prevention Program (DPP). Modified versions of the DPP lifestyle intervention are being translated into diverse community settings and have been successful in decreasing weight and improving metabolic markers. However, comprehensive evaluations of PA levels within these community translation intervention efforts are rare.PurposeTo evaluate the effectiveness of a DPP-based community lifestyle intervention for improving PA levels.Methods223 overweight adults at-risk for type 2 diabetes and/or cardiovascular disease were randomized (immediate or 6-month delayed-start) to a 12-month DPP-based lifestyle intervention. Past-month PA level was assessed at baseline and post-intervention with the Modifiable Activity Questionnaire. Simple and mixed-effects regression models were used to determine changes in PA level between and within groups over time.ResultsThe between-group mean difference for change in PA levels from baseline to 6 months indicated significantly greater improvement in the intervention compared to the delayed-start group [+6.72 (SE=3.01) MET-hrs/week; p=0.03]. Examining combined within-group change from baseline to post-intervention, mean PA levels significantly increased by +14.69 (SE=1.43) and +9.50 (SE= 1.40) MET-hrs/week at 6 and 12 months post-intervention, respectively. This PA change offset to approximately +10 MET-hrs/week at both 6 and 12 months after adjusting for baseline PA level and season (all; p<0.01). Other than season, sex impacted on change in PA level.ConclusionsThis community-based lifestyle intervention significantly increased PA levels among overweight adults at risk for type 2 diabetes and cardiovascular disease, even after adjusting for key variables.Clinicaltrialsgov identifierNCT01050205.

Project description:BackgroundType 2 diabetes mellitus (T2DM) has increased globally; with a disproportionate burden in South and Southeast Asian countries, including Nepal. There is an urgent need for clinically and cost-effective culturally adapted T2DM management programs. In this study, we aim to assess the effectiveness of community based culturally appropriate lifestyle intervention in improving the management and care of people with T2DM.MethodsWe will conduct a cluster randomized control trial to evaluate the effectiveness of community based culturally appropriate lifestyle intervention in improving T2DM outcomes. The trial will be conducted in 30 randomly selected healthcare facilities from two purposively selected districts (Kavrepalanchowk and Nuwakot districts) of Bagmati province, Nepal. The selected healthcare facilities are being randomized into 15 interventions (n = 15) and usual care (n = 15) groups. Those in the intervention will receive group-based 12 an hour-long fortnightly session delivered over 6 months period. The intervention package includes 12 planned modules related to diabetes care, ongoing support, supervision and monitoring, follow-up from the trained community health workers, and educational materials on diabetes self-management. The participants in the usual care groups will receive pictorial brochure on diabetes management and they will continue receiving the usual care available from the local health facilities. The primary outcome is HbA1c level, and the secondary outcomes include quality of life, health care utilization, and practice of self-care behaviour, depression, oral health quality of life, and economic assessment of the intervention. Two points measurements will be collected by the trained research assistants at baseline and at the end of the intervention.DiscussionThis study will provide tested approaches for culturally adapting T2DM interventions in the Nepalese context. The findings will also have practice and policy implications for T2DM prevention and management in Nepal.Trial registrationAustralia and New Zealand Clinical Trial Registry (ACTRN12621000531819). Registered on May 6, 2021.

Project description:BackgroundThis study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China.MethodsA randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke or cardiovascular disease. The patients were randomly assigned to one of three systolic-BP target groups: standard: 140 to < 150 mmHg; moderately intensive: 130 to < 140 mmHg; and intensive: < 130 mmHg. The patients were followed for 6 months.DiscussionThe optimal target for systolic blood pressure (SBP) lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7%, and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP-control protocols that fully consider the population's characteristics, such as age, sex, socio-economic status, compliance with medication, education level, and lifestyle. This randomized trial showed the feasibility and safety of the titration protocol to achieve desirable SBP targets (< 150, < 140, and < 130 mmHg) in a sample of rural, Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 h after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intensive group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups. This trial provided real-world experience and laid the foundation for a future, large-scale, BP target study.Trial registrationFeasibility Study of the Intensive Systolic Blood Pressure Control; ClinicalTrials.gov, ID: NCT02817503. Registered retrospectively on 29 June 2016.

Project description:BackgroundMaternal obesity is associated with significant racial disparities. People who identify as non-Hispanic Black and Latinx are at the highest risk related adverse short- and long-term health outcomes (eg, hypertension in pregnancy and postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of people who self-identify as non-Hispanic Black and Latinx or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions within community-based programs that serve birthing people may optimize trust and engagement, promote scalability and sustainability, and have the broadest public health impact.ObjectiveThe goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two-Home Visiting) implemented within home visiting compared to usual home visiting services on postpartum weight retention among pregnant or postpartum individuals, in particular those who identify as non-Hispanic Black and Latinx. Facilitators and barriers to implementation of the intervention within home visiting will be examined.MethodsWe describe the rationale and protocol for this hybrid type I effectiveness-implementation randomized controlled trial. In this paper, we highlight the community-engaged approach and trial design features that enable the implementation of the intervention within home visiting and demonstrate its applicability to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20 and 33 weeks of gestation and randomized 1:1 to Healthy for Two-Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated as 6-month postpartum weight minus earliest pregnancy weight (≤18 wk of gestation). The measures of implementation include intervention feasibility, acceptability, reach, adoption, and fidelity. Throughout the paper, we highlight the community input used to improve intervention effectiveness and study implementation and as a strategy to promote maternal health equity.ResultsThis study was funded in June 2021, and recruitment began in April 2023. As of November 2024, we enrolled 90 participants. Data collection to assess the intervention's effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026.ConclusionsThis hybrid type I effectiveness-implementation randomized controlled trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation within a community-based setting to maximize the future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities.Trial registrationClinicaltrials.gov NCT05619705; https://clinicaltrials.gov/study/NCT05619705.International registered report identifier (irrid)DERR1-10.2196/62847.

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Project description:BackgroundExcessive sodium intake is associated with high blood pressure and an increased risk of cardiovascular disease. However, reducing dietary salt has been challenging due to a lack of awareness and a high threshold in detecting saltiness.ObjectivesThe goal of this study is to evaluate the effectiveness of a combined intervention (intensive dietary education, food reformulation, environmental changes to facilitate salt reduction, and salt meter utilization), in comparison to standard education only, on salt intake and blood pressure.MethodsA cluster randomized-controlled trial was conducted on 219 hypertensive adults aged 18 to 70 years in Uthaithani, Thailand. Participants were randomized 1:1 into the intervention group (n = 111) and the control group (n = 108).ResultsThere were no differences in baseline characteristics between groups. The mean systolic and diastolic blood pressure was 143.6 and 82.1 mmHg and 142.2 and 81.4 mmHg in the intervention group, and the control group, respectively. The median 24-hour urinary sodium excretion was 3565 and 3312 mg/day, in the intervention and the control group, respectively. After 12 weeks, the change in systolic blood pressure was -13.5 versus -9.5 mmHg (P = 0.030) and diastolic blood pressure was -6.4 versus -4.8 mmHg (P = 0.164) in the intervention and control groups, respectively. Moreover, a reduction in 24-hour urine sodium excretion was observed [-575 versus -299 mg/day in the intervention and control groups, respectively (P = 0.194)]. The change in 24-hour urine sodium excretion was statistically significant and reduced from baseline in the intervention group (P = 0.004). The dietary salt intake was significantly improved and was statistically different between groups (P = 0.035).ConclusionsThe combined intervention significantly decreased systolic blood pressure and showed a trend towards reduced urine sodium excretion in hypertensive patients. These comprehensive approaches may be beneficial in reducing blood pressure and salt intake in the community.Clinical trial registrationThis trial was registered at Clinicaltrials.gov with the identifier NCT05397054. https://classic.clinicaltrials.gov/ct2/show/NCT05397054.

Project description:BackgroundManaging noncommunicable diseases through primary healthcare has been identified as the key strategy to achieve universal health coverage but is challenging in most low- and middle-income countries. Stroke is the leading cause of death and disability in rural China. This study aims to determine whether a primary care-based integrated mobile health intervention (SINEMA intervention) could improve stroke management in rural China.Methods and findingsBased on extensive barrier analyses, contextual research, and feasibility studies, we conducted a community-based, two-arm cluster-randomized controlled trial with blinded outcome assessment in Hebei Province, rural Northern China including 1,299 stroke patients (mean age: 65.7 [SD:8.2], 42.6% females, 71.2% received education below primary school) recruited from 50 villages between June 23 and July 21, 2017. Villages were randomly assigned (1:1) to either the intervention or control arm (usual care). In the intervention arm, village doctors who were government-sponsored primary healthcare providers received training, conducted monthly follow-up visits supported by an Android-based mobile application, and received performance-based payments. Participants received monthly doctor visits and automatically dispatched daily voice messages. The primary outcome was the 12-month change in systolic blood pressure (BP). Secondary outcomes were predefined, including diastolic BP, health-related quality of life, physical activity level, self-reported medication adherence (antiplatelet, statin, and antihypertensive), and performance in "timed up and go" test. Analyses were conducted in the intention-to-treat framework at the individual level with clusters and stratified design accounted for by following the prepublished statistical analysis plan. All villages completed the 12-month follow-up, and 611 (intervention) and 615 (control) patients were successfully followed (3.4% lost to follow-up among survivors). The program was implemented with high fidelity, and the annual program delivery cost per capita was US$24.3. There was a significant reduction in systolic BP in the intervention as compared with the control group with an adjusted mean difference: -2.8 mm Hg (95% CI -4.8, -0.9; p = 0.005). The intervention was significantly associated with improvements in 6 out of 7 secondary outcomes in diastolic BP reduction (p < 0.001), health-related quality of life (p = 0.008), physical activity level (p < 0.001), adherence in statin (p = 0.003) and antihypertensive medicines (p = 0.039), and performance in "timed up and go" test (p = 0.022). We observed reductions in all exploratory outcomes, including stroke recurrence (4.4% versus 9.3%; risk ratio [RR] = 0.46, 95% CI 0.32, 0.66; risk difference [RD] = 4.9 percentage points [pp]), hospitalization (4.4% versus 9.3%; RR = 0.45, 95% CI 0.32, 0.62; RD = 4.9 pp), disability (20.9% versus 30.2%; RR = 0.65, 95% CI 0.53, 0.79; RD = 9.3 pp), and death (1.8% versus 3.1%; RR = 0.52, 95% CI 0.28, 0.96; RD = 1.3 pp). Limitations include the relatively short study duration of only 1 year and the generalizability of our findings beyond the study setting.ConclusionsIn this study, a primary care-based mobile health intervention integrating provider-centered and patient-facing technology was effective in reducing BP and improving stroke secondary prevention in a resource-limited rural setting in China.Trial registrationClinicalTrials.gov NCT03185858.

Project description:IntroductionAlthough the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes.Study designRCT.Setting/participantsNinety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016.InterventionThe 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care.Main outcome measuresWeight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.ResultsILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063).ConclusionsIn the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

Dataset Information

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.

Background

Objective

Design

Participants

Main measures

Key results

Conclusion

Publications

Effectiveness of Lifestyle and Drug Intervention on Hypertensive Patients: a Randomized Community Intervention Trial in Rural China.

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