Results of a randomized controlled trial published in Circulation: Cardiovascular Quality and Outcomes indicate that therapeutic lifestyle change interventions administered in a community setting are effective for blood pressure (BP) reduction among black individuals with uncontrolled hypertension.1
The Faith-Based Approaches in the Treatment of Hypertension (FAITH; NCT01065831) Study evaluated the effectiveness of a therapeutic lifestyle change intervention with motivational interviewing for BP reduction among individuals from 32 New York City churches. Participants were black adults (≥18 years) with a self-reported diagnosis of hypertension and uncontrolled BP (BP ≥140/90 mm Hg or BP ≥130/80 mm Hg with diabetes mellitus or chronic kidney disease). Individuals were recruited from churches after on-site worship services or other events. Participants were randomly assigned to either the motivational interviewing-therapeutic lifestyle change intervention (n=172) or to health education as control treatment (n=201). The motivational interviewing-therapeutic lifestyle change arm comprised 11 weekly group sessions on therapeutic lifestyle change with 3 additional monthly motivational interviewing sessions delivered by health advisors. The health education control group received 1 therapeutic lifestyle change session and 10 subsequent sessions on health topics delivered by local experts. As outcome measures, investigators captured BP reduction at 6 months and at 9 months. BP control at 9 months was also assessed.
The study cohort was mean age 63 years, and 76.0% of participants were women. At baseline, patients had a mean BP of 153/87 mm Hg. At 6 months posttreatment, both study arms experienced reductions in systolic BP; however, the motivational interviewing-therapeutic lifestyle change intervention was associated with a more significant effect. The between-group difference in 6-month systolic BP reduction was -5.79 mm Hg (P =.029). This trend persisted at 9 months, although at reduced statistical significance (P =.068). Between-group differences in diastolic BP reduction and mean arterial pressure were not significant at 6 months. Additionally, a greater proportion of individuals in the motivational interviewing-therapeutic lifestyle change group achieved improvements in BP control at 9 months compared with the control group (57.0% vs 48.8%). However, this difference was not statistically significant.
These data suggest that both therapeutic lifestyle change and health education interventions may be effective for BP reduction in black communities, with a substantial advantage offered by therapeutic lifestyle change specifically. Additionally, this study offers information on the potential efficacy of community-based health interventions. Community-based settings offer low-cost and “culturally salient” means of communication with underserved demographics, wrote study investigators.
Following the publication of the FAITH trial data, Jeremy B Sussman, MD, MS, and Michele Heisler, MD, MPA, of the Department of Internal Medicine at the University of Michigan, Ann Arbor, commented on the research.2
Although the FAITH trial offered promising information on the success of a therapeutic lifestyle change intervention for reducing systolic BP, little effect was observed for diastolic BP. Drs Sussman and Heisler compared results of the FAITH data with results from another community-based trial published in the New England Journal of Medicine in which male patrons from 52 barbershops across Los Angeles were randomly assigned to either pharmaceutical intervention under physician supervision or to health education on behavioral changes.3
The Los Angeles trial achieved “stunning” reductions both in systolic (-21.6 mm Hg) and diastolic (-14.9 mm Hg) BP at 6 months follow-up.3 Compared with these figures, the FAITH trial achieved relatively modest results. Dr Sussman emphasized methodologic differences between the studies: behavioral interventions alone, like those implemented in the FAITH trial, are generally less effective than medication management for BP reduction.4 Additionally, retention rates differed across trials, with just 46% of FAITH participants completing all 3 telephone counseling sessions.
Conversely, participants in the barbershop program received an average of 7 in-person pharmacist visits and 4 follow-up telephone calls. Additionally, the different study demographics may have influenced attrition rates: the barbershop trial enrolled men who had at least 1 haircut every 6 weeks for at least 6 months, whereas the FAITH trial enrolled participants who may or may not have been regular church attendees. As such, the barbershop trial had a significantly lower attrition rate compared with the FAITH trial. These disparities in participant retention rates highlight the potential advantages of certain recruitment strategies.
Both studies, however, reflect the substantial difficulty of implementing community-based trials. Both trials reported difficulties with recruitment and screening. Participating barbershops offered substantial incentives, which is likely an unsustainable practice for subsequent studies. In eliminating health disparities, community-based practices remain an important tool to engage “difficult-to-reach communities.”
The FAITH trial and the Los Angeles study were both funded by the Center for Translation Research and Implementation Science, which has declared a focus on both “community health and disparities research.”5 As the research landscape surrounding community-based interventions evolves, disparities in cardiovascular disease outcomes will narrow.
- Schoenthaler AM, Lancaster KJ, Chaplin W, Butler M, Forsyth J, Ogedegbe G. Cluster randomized clinical trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in blacks. Circ Cardiovasc Qual Outcomes. 2018;11:e004691.
- Sussman JB, Heisler M. Can community-based interventions improve cardiovascular risk in high-risk patients? Circ Cardiovasc Qual Outcomes. 2018;11:e005149.
- Victor RG, Lynch K, Li N, et al. A cluster-randomized trial of blood-pressure reduction in black barbershops. N Engl J Med. 2018;378:1291-1301.
- Alageel S, Gulliford MC, McDermott L, Wright AJ. Multiple health behaviour change interventions for primary prevention of cardiovascular disease in primary care: systematic review and meta-analysis. BMJ Open. 2017;7:e015375.
- Mensah GA, Engelgau M, Stoney C, et al; for the Trans-NHLBI T4 Translation Research Work Groups. News from NIH: a center for translation research and implementation science. Transl Behav Med. 2015;5:127-130.