Greater reduction in SBP with church-based lifestyle intervention in black communities
Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks
Introduction and methods
Although therapeutic lifestyle changes (TLC) have beneficial effects on blood pressure (BP) reduction [1,2], its effectiveness in community-based settings remains untested, particularly in black churches [3-5]. Churches are a valuable channel for delivery of evidence-based programs with many advantages for undertaking behavior change programs . Some studies have focused on the effect of church-based lifestyle interventions on BP reduction, however, these studies often deal with methodologic limitations [7-11]. Therefore, this study evaluated the comparative effectiveness of a faith-based TLC intervention plus motivational interviewing (MINT-TLC) delivered by lay health advisors (LHAs) versus a health education (HE) control on BP reduction in hypertensive blacks.
The FAITH (Faith-Based Approaches in the Treatment of Hypertension) trial was a 2-arm cluster randomized controlled trial including black individuals aged ≥18 years with self-reported diagnosis of hypertension and uncontrolled BP, and was conducted in 32 New York City churches whose members were predominantly of African descent. Churches were 1:1 randomized to either the MINT-TLC (n=172) or HE group (n=201).
MINT-TLC consisted of 11 90-minute weekly sessions of an evidence-based TLC program delivered by LHAs to promote healthy behaviors followed by 3 monthly session. HE group participants received 1 session on hypertension management plus 10 informational sessions on HE topics led by health experts.
The primary outcome was change in BP (mean arterial BP [MAP], systolic BP [SBP] and diastolic BP [DBP]) from baseline to 6 months. Secondary outcome was BP control at 9 months. BP was measured by a validated automated BP monitor. BP control was defined as mean BP <140/90 mm Hg (or mean BP <130/80 mm Hg for those with diabetes mellitus or kidney disease).
Effects on BP reduction at 6 months (intent-to-treat analysis)
- MAP significantly reduced from baseline to 6 months in both the MINT-TLC (−10.08 mmHg, 95%CI: −15.64 to −4.52) and HE groups (−7.83 mmHg, 95%CI: −10.08 to −5.59). Effect size for MAP was not significant between treatment groups (−2.24 mm Hg, 95%CI: −5.57 to 1.08).
- A greater SBP reduction was found in the MINT-TLC group (−16.53 mmHg; 95%CI: −25.24 to −7.83) compared with the HE group (−10.74 mmHg, 95%CI: −14.25 to −7.24). There was a significant between-group difference of −5.79 mmHg (95%CI: −10.99 to −0.59, P=0.029).
- DBP was significantly reduced from baseline to 6 months in both groups (MINT-TLC: -6.6, 95%CI: -11.3 to 01.9 and HE: -6.2, 95%CI: -8.1 to -4.3), without a significant between group difference (−0.41 mmHg, 95%CI: −3.22 to 2.40).
Effects on BP control and reduction at 9 months
- BP control (defined as mean BP <140/90 mmHg or <130/80 mmHg for those with DM or kidney disease) was improved in both groups at 9 months (57.0% in the MINT-TLC group versus 48.8% in the HE group), and the difference between groups was not significant (odds ratio: 1.43; 95%CI: 0.90–2.28).
- Linear regression using 9-month levels of MAP did not show a significant treatment effect when comparing the groups (2.81 mmHg, 95%CI: −5.71 to 0.09).
- Greater reductions in BP were observed in the MINT-TLC groups (−18.2 mm Hg; 95%CI: −27.6 to −8.8) between baseline and 9 months, compared with the HE groups (−13.0 mmHg, 95%CI: −16.8 to −9.2 mm Hg).
- The treatment effect on SBP was attenuated at 9 months (estimated between-group difference of −5.21 mm Hg, 95%CI: −10.80 to 0.39, P=0.068).
- The treatment effect at 9 months on DBP remained non-statistically significant (−1.13 mmHg, 95%CI: −3.54 to 1.29).
A community-based lifestyle intervention delivered in churches was associated with significantly greater reductions in SBP at 6 months when compared with health education alone, among blacks with uncontrolled hypertension, which persisted at 9 months. No effects of lifestyle intervention were seen on MAP and DBP at 6 months, nor on BP control at 9 months.
In their editorial comment, Sussman and Heisler  explain the modest effects reported in the FAITH study compared with the stunning findings in the barbershop study  reported earlier this year: the use of different interventions, different levels of participant engagement in the intervention, differences in study population. Next, the authors point to the effectiveness of using trusted members of the community to deliver care in high-risk populations and the value of reaching out to communities with limited access or who do not trust the community, but also to necessary links between community and healthcare organizations to engage difficult-to-reach communities. They discuss an important limitation of both studies reflecting challenges in community-based practice: the extraordinary challenge in reaching the desired community. The authors conclude: ‘The National Heart Lung and Blood Institute’s dedication to developing new approaches to eliminate racial and other disparities in cardiovascular disease outcomes is a promising sign of growth and interest in difficult-to-reach communities’.
Skills-based discharge program on BP reduction with stroke/TIA
Interestingly, another simultaneously published randomized trial  reported on another community-based approach among Hispanic individuals with mild/moderate stroke and TIA. The study showed that a culturally tailored, skills-based discharge program with follow-up reinforcement leads to a nonsignificant 2.5 mmHg greater SBP reduction at 12 months post discharge and a statistically significant 9.9 mm Hg greater SBP reduction in the intervention group, compared with usual care, among Hispanic individuals with mild/moderate stroke and TIA. We refer to the editorial comment  for discussion on the design of the intervention and disparity in effectiveness between race/ethnics groups, and limitations of the study.