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

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Clinical trial registration: Trial Number NCT01070056 at https://ichgcp.net/clinical-trials-registry/NCT01070056?term=TLC+clinic&rank=1.

Keywords: African American; blood pressure; hypertension; lifestyle changes; practice-based..

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Figures

Figure 1.

CONSORT flow diagram.

Figure 2.

Observed and adjusted means for systolic blood pressure by randomization group over time. The adjusted means in the graphic are based on a repeated measures analysis performed using SAS Proc Mixed, adjusting for clustering within primary care physician assuming a compound symmetry covariance structure for systolic blood pressure. Up to 3 waves of data were included in the analyses. The time by intervention group status term was not significant.

Figure 3.

Observed and adjusted means for diastolic blood pressure by randomization group over time. The adjusted means in the graphic are based on a repeated measures analysis performed using SAS Proc Mixed, adjusting for clustering within primary care physician assuming a compound symmetry covariance structure for diastolic blood pressure. Up to 3 waves of data were included in the analyses. The time by intervention group status term was not significant.