Dataset Information

Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks.

ABSTRACT: Although the efficacy of therapeutic lifestyle change (TLC) interventions are well proven, their relative effectiveness vs. single-session lifestyle counseling (SSC) on blood pressure (BP) reduction in primary care practices remains largely untested in hypertensive Blacks. The aim of this trial was to evaluate the comparative effectiveness of a comprehensive practice-based TLC intervention (motivational interviewing (MINT)-TLC) vs. SSC on BP reduction among 194 Blacks with uncontrolled hypertension.The MINT-TLC arm included 10 weekly group classes on TLC, followed by 3 individual MINT sessions. The SSC group received 1 individual counseling session on lifestyle modification plus print versions of the intervention material. The primary outcome was within-patient change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 6 months. The secondary outcome was BP control at 6 months.Mean age of the total sample was 57 (10.2) years; 50% were women, and the mean baseline BP was 147.4/89.3mm Hg. Eighty-four percent of SSC and 77% of MINT-TLC patients completed the final 6-month assessments. BP declined significantly (P < 0.001) in both groups at 6 months with a net-adjusted systolic BP reduction of 12.9 mm Hg for the SSC group vs. 9.5mm Hg for the MINT-TLC group (P = 0.18); and diastolic BP reduction of 7.6 and 7.2mm Hg for the SSC and MINT-TLC group, respectively (P = 0.79). The between-group difference in proportion of patients with adequate BP control at 6 months was nonsignificant (P = 0.82).A significant group difference in BP between the intervention groups was not observed among a sample of hypertensive Blacks. Implementation of the pragmatic single-session intervention and its effects on utilization of healthcare services should be further evaluated.Trial Number NCT01070056 at http://clinicaltrials.gov/ct2/show/NCT01070056?term=TLC+clinic&rank=1.

SUBMITTER: Schoenthaler A

PROVIDER: S-EPMC4751244 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks.

Schoenthaler Antoinette A Luerassi Leanne L Silver Stephanie S Odedosu Taiye T Kong Jian J Ravenell Joseph J Teresi Jeanne A JA Ogedegbe Gbenga G

American journal of hypertension 20150701 2

<h4>Background</h4>Although the efficacy of therapeutic lifestyle change (TLC) interventions are well proven, their relative effectiveness vs. single-session lifestyle counseling (SSC) on blood pressure (BP) reduction in primary care practices remains largely untested in hypertensive Blacks. The aim of this trial was to evaluate the comparative effectiveness of a comprehensive practice-based TLC intervention (motivational interviewing (MINT)-TLC) vs. SSC on BP reduction among 194 Blacks with unc ...[more]

PMID: 26135553

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Project description:BackgroundStrict medication guidance and lifestyle interventions to manage blood pressure (BP) in hypertensive patients are typically difficult to follow.ObjectiveTo evaluate the 1-year effectiveness of lifestyle and drug intervention in the management of rural hypertensive patients.DesignRandomized community intervention trial.ParticipantsThe 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 measuresData 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 resultsBP 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).ConclusionThe addition of lifestyle intervention by physicians or nurses helps control BP effectively and lowers BP better than usual care with antihypertensive drug therapy alone.

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:BACKGROUND:The 'Eat Right, Be Positive About Your Body and Live Actively' (EPaL) intervention programme was developed to prevent overweight and disordered eating in Malaysian adolescents. This study aimed to evaluate the effectiveness of the EPaL programme on knowledge, attitudes and practices on healthy lifestyle and body composition (body mass index z-score [zBMI], waist circumference [WC] and body fat percentage [BF%]) among adolescents. METHODS:All measures were taken at three time points: before intervention (Pre), after intervention (Post I) and 3?months after intervention (Post II). The intervention group (IG) participated in the EPaL programme for 16?weeks, whereas the comparison group (CG) received no intervention. Seventy-six adolescents (IG: n?=?34; CG: n?=?42) aged 13-14?years were included in the final analysis. Repeated measures analysis of covariance (ANCOVA) was used to assess the impact of the EPaL intervention programme on the measures between groups (IG and CG) at Post I and Post II. RESULTS:The IG reported significantly higher knowledge scores at both Post I (adjusted mean difference?=?3.34; 95% confidence interval [CI]?=?0.99, 5.69; p?=?0.006) and Post II (adjusted mean difference?=?2.82; 95% CI?=?0.86, 4.78; p?=?0.005) compared with the CG. No significant differences between the IG and CG were found at either Post I or Post II in attitudes, practices, zBMI, WC and BF%. The proportion of participants who were overweight or obese was consistent from Pre to Post II in the IG (35.3%) and increased from 26.2% at Pre to 28.5% at Post II in the CG, but the difference was not statistically significant. The proportion of participants who had abdominal obesity in the IG decreased from 17.6% at Pre to 14.7% at Post II and increased from 16.7% at Pre to 21.4% at Post II in the CG, but the differences were not statistically significant. CONCLUSION:Despite no significant reduction of body composition, this programme shows the positive effect on the adolescents' knowledge regarding healthy lifestyle. This study contributes to the evidence on the effectiveness of school-based health interventions in Malaysian adolescents. TRIAL REGISTRATION:UMIN Clinical Trial Registration UMIN000024349. Registered 11 October 2016.

Project description:BackgroundLifestyle interventions can substantially improve obesity and cardiometabolic risks. However, evidence of long-term benefits of national intervention is sparse. We aimed to evaluate the long-term effectiveness of a nationwide program for abdominal obesity.MethodsA retrospective cohort study was performed using a longitudinal nationwide individual data in subjects aged 40-74 years who underwent checkups in fiscal year (FY) 2008. Lifestyle interventions were provided via interview in subjects with abdominal obesity and at least one cardiometabolic risk factor. Subjects who attended the lifestyle intervention (participants) were compared to those who did not attend (non-participants). Outcomes were waist circumferences (WC) and body mass index (BMI) reduction, reversal of metabolic syndrome (MetS), and changes in cardiometabolic risks. We used a three-step process with robust analytic approaches to account for selection bias that included traditional multivariate analysis, propensity-score matching and instrumental variable (IV) analyses.ResultsOf 19,969,722 subjects, 4,370,042 were eligible for analyses; 111,779 participants and 907,909 non-participants. A higher percentage of participants had ?5% reductions in obesity profiles at year 3, compared to non-participants (WC, 21.4% vs 16.1%; BMI, 17.6% vs 13.6%; p<0.001 each). Participants also had higher reversal for MetS (adjusted odds ratio 1.31; 95% confidence interval: 1.29-1.33; p<0.001). Greater reductions in cardiometabolic risks were observed in participants. Those results were confirmed in analyses using a propensity score-matched cohort (n = 75,777, each) and IV analyses. Limitations of this work include the use of non-randomized national data in Japan to assess the effectiveness of the nationwide preventive program.ConclusionsIn the nationwide lifestyle intervention for abdominal obesity, the at-risk population achieved significant reductions in WC, BMI, and cardiometabolic risks in 3 years. This study provides evidence that the nationwide program effectively achieved long-term improvement in abdominal obesity and cardiometabolic risks.

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.

Project description:BackgroundLifestyle interventions (diet, physical activity and/or behavioural) to optimise gestational weight gain can prevent adverse maternal outcomes such as gestational diabetes, pre-eclampsia and caesarean section.ObjectiveWe aimed to model the cost effectiveness of lifestyle interventions during pregnancy on reducing adverse maternal outcomes.MethodsDecision tree modelling was used to determine the cost effectiveness of lifestyle interventions compared with usual care on preventing cases of gestational diabetes and hypertensive disease in pregnancy. Participants were pregnant women receiving routine antenatal care in secondary and tertiary care hospitals. The main outcome measures were cases of gestational diabetes and/or hypertensive disease in pregnancy prevented, costs, and incremental cost-effectiveness ratios. Analysis was conducted from the perspective of the Australian healthcare system, with a time horizon of early pregnancy to discharge after birth.ResultsWomen in the intervention group were 2.25% less likely to have gestational diabetes and/or hypertensive disease in pregnancy (9.53%) compared with the control group (11.78%). Intervention costs were Australian dollars (AUD) 228 per person. Costs were AUD33 per person higher in the intervention group (AUD8281) than the control group (AUD8248). The incremental cost-effectiveness ratio was AUD1470 per case prevented. Sensitivity analysis showed that base-case results were robust. In the probabilistic sensitivity analysis, 44.8% of data points fell within the north-east quadrant, and 52.2% in the south-east quadrant (cost saving), with a 95% confidence interval ranging from AUD - 50,018 to 32,779 per case prevented.ConclusionsWhile there is no formally accepted cost-effectiveness threshold for willingness-to-pay to prevent an adverse maternal event, the cost per person receiving a lifestyle intervention compared with controls was close to neutral, and therefore likely to be cost effective. Exploration of the cost effectiveness of different lifestyle delivery modes across various models of antenatal care is now required. Future cost-effectiveness studies should investigate longer time horizons, quality-adjusted life-years and productivity loss.Trial registrationNot applicable.

Dataset Information

Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks.

Publications

Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks.

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