Cluster Randomized Trial for Hypertension Control: Effect on Lifestyles and Body Weight

Abstract

Introduction: Lifestyle modification, such as healthy diet habits, regular physical activity, and maintaining a normal body weight, must be prescribed to all hypertensive individuals. This study aims to test whether a multicomponent intervention is effective in improving lifestyle and body weight among low-income families.

Study design: Cluster randomized trial conducted between June 2013 and October 2016.

Setting/participants: A total of 1,954 uninsured adult patients were recruited in the study within 18 public primary healthcare centers of Argentina.

Intervention: Components targeting the healthcare system, providers, and family groups were delivered by community health workers; tailored text messages were sent for 18 months.

Main outcome measures: Changes in the proportion of behavioral risk factors and body weight from baseline to end of follow-up. Data were analyzed in 2017.

Results: Low fruit and vegetable consumption (fewer than 5 servings per day) decreased from 96.4% at baseline to 92.6% at 18 months in the intervention group, whereas in the control group it increased from 97.0% to 99.9% (p=0.0110). The proportion of low physical activity (<600 MET-minutes/week) decreased from 54.3% at baseline to 46.2% at 18 months in the intervention group and kept constant around 52% (p=0.0232) in the control group. The intervention had no effect on alcohol intake (p=0.7807), smoking (p=0.7607), addition of salt while cooking or at the table (p=0.7273), or body weight (p=0.4000).

Conclusions: The multicomponent intervention was effective for increasing fruit and vegetable intake and physical activity with no effect on alcohol consumption, smoking, addition of salt, or body weight among low-income families in Argentina.

Trial registration: This study is registered at www.clinicaltrials.gov NCT01834131.