Structured Lifestyle Modification Interventions Involving Frontline Health Workers for Population‐Level Blood Pressure Reduction: Results of a Cluster Randomized Controlled Trial in India (DISHA Study)

Abstract

Background Population‐wide reduction in mean blood pressure is proposed as a key strategy for primary prevention of cardiovascular disease. We evaluated the effectiveness of a task‐sharing strategy involving frontline health workers in the primary prevention of elevated blood pressure. Methods and Results We conducted DISHA (Diet and lifestyle Interventions for Hypertension Risk reduction through Anganwadi Workers and Accredited Social Health Activists) study, a cluster randomized controlled trial involving 12 villages each from 4 states in India. Frontline health workers delivered a custom‐made and structured lifestyle modification intervention in the selected villages. A baseline survey was conducted in 23 and 24 clusters in the control (n=6663) and intervention (n=7150) groups, respectively. The baseline characteristics were similar between control and intervention clusters. In total 5616 participants from 23 clusters in the control area and 5699 participants from 24 clusters in the intervention area participated in a repeat cross‐sectional survey conducted immediately after the intervention phase of 18‐months. The mean (SD) systolic blood pressure increased from 125.7 (18.1) mm Hg to 126.1 (16.8) mm Hg in the control clusters, and it increased from 124.4 (17.8) mm Hg to 126.7 (17.5) mm Hg in the intervention clusters. The population average adjusted mean difference in difference in systolic blood pressure was 1.75 mm Hg (95% CI, −0.21 to 3.70). Conclusions Task‐sharing interventions involving minimally trained nonphysician health workers are not effective in reducing population average blood pressure in India. Expanding the scope of task sharing and intensive training of health workers such as nurses, nutritionists, or health counselors in management of cardiovascular risk at the population level may be more effective in primary prevention of cardiovascular disease. Registration URL: https://www.ctri.nic.in ; Unique identifier: CTRI/2013/10/004049.

Effects of lifestyle interventions on cardiovascular risk factors in South Asians: a systematic review and meta-analysis

“…Of the 35 included studies (online supplemental table S1), 26 were parallel-arm RCTs,10 32 33 43–45 52–72 and 8 were cluster RCTs 30 34–40. Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61.…”

“…Of the 35 included studies (online supplemental table S1), 26 were parallel-arm RCTs,10 32 33 43–45 52–72 and 8 were cluster RCTs 30 34–40. Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61. Most participants in the studies had at least one major risk factor for CVD such as diabetes,33 54 60 63 67–69 71 dyslipidaemia,43 55 64 hypertension,35 40 44 45 65 66 70 72 obesity53 57 or metabolic syndrome 36 56.…”

“…Thirty-one studies were conducted in South Asian countries (20 in India, 5 in Pakistan, 3 in Nepal, 2 in Sri Lanka and 1 in Bangladesh)30 32–40 43–45 53–60 62–64 66–72 and 4 studies were conducted outside of Asia (1 in the USA and 3 in Canada) 10 32 52 61. Most participants in the studies had at least one major risk factor for CVD such as diabetes,33 54 60 63 67–69 71 dyslipidaemia,43 55 64 hypertension,35 40 44 45 65 66 70 72 obesity53 57 or metabolic syndrome 36 56. Eighteen studies assessed diet alone34 39 43–45 53–59 62 64 67–69 71; 5 studies assessed physical activity alone32 33 60 65 72; and 12 studies assessed a combination of diet and physical activity modifications 10 30 35–38 40 52 61 63 66 70.…”

“…Generic inverse variance meta-analysis was conducted for one of the cluster trials which reported effect estimates adjusted for clustering but not individual participant data. 40 No ongoing studies that have not published/provided results were included in the review. The RevMan calculator 28 was used to calculate SD, SEs or 95% CIs, where necessary.…”

“…Most included cluster randomised trials reported individual participant data,30 34–39 adjusted for the clustering effect, which made it possible to use directly in the authors’ meta-analyses. Generic inverse variance meta-analysis was conducted for one of the cluster trials which reported effect estimates adjusted for clustering but not individual participant data 40. No ongoing studies that have not published/provided results were included in the review.…”