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SYNOPSIS: A therapeutic lifestyle change intervention delivered in churches led to a significantly greater reduction in systolic blood pressure in hypertensive blacks than health education alone.
SOURCE: Schoenthaler AM, et al. Cluster randomized clinical trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in blacks. Circ Cardiovasc Qual Outcomes 2018;11:e004691.
It is estimated that up to 46% of the U.S. adult population has hypertension. For non-Hispanic blacks, this prevalence increases to greater than 50%.1 According to the 2017 Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults, hypertension-related morbidity and mortality are more common in blacks and Hispanic-Americans than in whites. Blacks have a 1.5-times greater risk of heart failure, 1.8-times greater risk of fatal strokes, and 4.2-times greater risk of end-stage renal disease than whites.1
Nonpharmacologic therapy, including lifestyle changes such as weight loss, sodium reduction, and increased physical activity, are known to be effective in lowering blood pressure. The 2017 guidelines recommend nonpharmacologic therapy first for Stage 1 hypertension (systolic blood pressure [SBP] 130-139 mmHg or diastolic blood pressure [DBP] 80-89 mmHg) without clinical atherosclerotic cardiovascular disease (ASCVD) and low 10-year CVD risk. It is recommended that patients with Stage 1 high CVD risk of clinical ASCVD and Stage 2 hypertension (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) use blood pressure-lowering medication in combination with nonpharmacologic therapy.1
Schoenthaler et al sought to determine the effectiveness a therapeutic lifestyle change (TLC) with motivational interviewing delivered in an influential institution in black communities, the church, compared to health education (HE). They cited several reasons for pursuing this research, including problems with previous studies in this area and the vital nature of translating evidence-based practice to community settings for the successful reduction in racial disparities. There is evidence that faith organizations have become important partners in the endeavor to reduce health disparities.2
Data for this trial were collected from 373 participants from 32 New York City churches from 2010 through 2014. Uncontrolled blood pressure was defined as ≥ 140/90 mmHg or ≥ 130/80 mmHg for persons with diabetes mellitus or chronic kidney disease. The blood pressure was measured using an automatic blood pressure monitor. Eligibility criteria included the following: self-identified as black, age ≥ 18 years, self-reported diagnosis of hypertension, and uncontrolled blood pressure.
Participants were randomized by church, with churches randomized 1:1 to either treatment or control group per four-church cohort. A total of eight cohorts were recruited (32 churches). Randomization occurred after the baseline assessment. Data were collected at baseline, three months, six months, and nine months. The primary endpoint was a reduction in blood pressure at six months. Secondary endpoints were blood pressure control and reduction at nine months. For the intervention, the HE group was used as an attention control and compared to TLC with motivational interviewing. The HE control group received one group session on hypertension-related TLC, in contrast to 11 sessions in the treatment group and 10 sessions on health topics other than hypertension.
The motivational interviewing with TLC (MINT-TLC) arm included 11 group weekly sessions on TLC, followed by three monthly individual sessions of motivational interviewing. The HE group did not have individual monthly motivational interviewing sessions. In the weekly sessions, participants focused on implementing health behaviors, meal planning, stress management, medication adherence, tasting healthy foods, and goal setting. Elements of prayer, scripture, and faith-based discussion were used to tailor the program to church members. The group sessions were adapted from PREMIER and the Healthy Eating and Lifestyle Program trials.
The MINT-TLC group sessions were led by trained lay health advisors (LHA) from the churches, and the HE groups were provided by local experts. The researchers recruited three to four members at the church to serve as the LHAs and provided two-day trainings in both the trial curriculum and motivational interviewing prior to group sessions, as well as weekly debrief calls and monthly booster sessions to the LHAs. Local experts for the HE attention control group were recruited from nonprofit health organizations, the Department of Health, and academic institutions. Aside from one session on hypertension and the National Institutes of Health’s manual “Your Guide to Lowering Blood Pressure,”3 the HE groups session topics were unrelated to hypertension, and included fire safety, environmental health, and Alzheimer's disease.
A total of 373 participants were enrolled in the trial; 172 were assigned to the MINT-TLC group and 201 were assigned to the HE control group. Average attendance was 58% and 56% for the MINT-TLC and HE groups, respectively. At the end of six months, 29% (29.7% in the MINT-TLC group, 27.4% in the HE group) of the 373 participants did not have complete data. Both groups had a significant reduction in SBP from baseline to six months. There was a greater SBP reduction in the MINT-TLC group (-16.53 mmHg; 95% CI, -25.24 to -7.83) than in the HE group (-10.74 mmHg; 95% CI, -14.25 to -7.24) and a significant between-group difference of -5.79 mmHg (P = 0.029; 95% CI, -10.99 to -0.59).2 Both groups demonstrated a significant reduction in DBP from baseline to six months. The between-group difference in the treatment was not significant for DBP (-0.41 mm Hg; 95% CI, -3.22 to 2.40). (See Table 1.)
At nine months, both groups continued to have a significant reduction in SBP from baseline: MINT-TLC (-18.2 mmHg; 95% CI, -27.6 to -8.8) and HE group (-13.0 mmHg; 95% CI, -16.8 to -9.2 mmHg), although the difference between groups was smaller (-5.21 mmHg, P = 0.068; 95% CI, -10.80 to 0.39). Also, both groups achieved significant improvement in blood pressure control (57.0% in the MINT-TLC group vs. 48.8% in the HE group). However, there was no significant difference between the two arms regarding blood pressure control (odds ratio, 1.43; 95% CI, 0.90-2.28).
Clinically, if a patient was interested in participating in a community-based therapeutic lifestyle intervention, from this research, it appears that it would be prudent to encourage them to do so. Although the researchers did not evaluate the specific characteristics of TLC that contributed to blood pressure reduction, one theory is that LHAs communicate health messages in culturally relevant ways.
Because a considerable portion of the trial participants still had uncontrolled hypertension despite a large number taking medication, other interventions, including further medication adjustment with their primary care provider, should be considered. However, even without control, a 10 mmHg reduction in blood pressure significantly reduces the risk of major cardiovascular events, coronary heart disease, and heart failure.4
The authors did not track if participants underwent any medication changes while involved in the study or if there was better adherence to medication regimens. This would have been useful information, since medication nonadherence is a major component in the health disparity between blacks and whites.5 As of 2017, no single strategy to combat medication nonadherence had proven effective across all patient populations.
It does appear that this could be reproduced with other religious groups. It also could be modified for nonreligious community groups by substituting the prayer, scripture, and faith-based discussion to items important to the community group. It would be helpful to see more research on sustainability and a cost breakdown of the training program and compensation for the lay health advisors. It also would be helpful to see if the beneficial effect of the intervention persisted beyond nine months, since the intervention’s effectiveness appeared to wane over time.
Integrative Medicine Alert’s Executive Editor David Kiefer, MD; Peer Reviewer Suhani Bora, MD; Relias Media Editorial Group Manager Leslie Coplin; Editor Jonathan Springston; and Accreditations Manager Amy M. Johnson, MSN, RN, CPN, report no financial relationships relevant to this field of study.