Key result
Comprehensive lifestyle intervention fails to reduce systolic BP over single counseling in hypertensive Black patients.
Why the study?
The relative effectiveness of comprehensive therapeutic lifestyle change interventions versus single-session lifestyle counseling on blood pressure reduction in hypertensive Blacks in primary care remains largely untested.
RCT (n=194)
Yes
Absolute Event Rate: 9.5% vs 12.9%
p-value: p=0.18
Comparable BP reductions with SSC and MINT-TLC; leaves open whether intensive programs add value in primary care for hypertensive Blacks.
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 http://clinicaltrials.gov/ct2/show/NCT01070056?term=TLC+clinic&rank=1.
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Schoenthaler et al. (2015) conducted an RCT in uncontrolled hypertension (n=194). motivational interviewing (MINT)-TLC vs. single-session lifestyle counseling (SSC) was evaluated on within-patient change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 6 months (p=0.18). MINT-TLC comprehensive lifestyle intervention did not significantly reduce systolic blood pressure compared to single-session counseling in hypertensive Blacks (9.5 vs 12.9 mm Hg reduction; P=0.18).
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