Protocol for Improving Hypertension and Diabetes Control Through Lifestyle Intervention in a Cluster Randomized Clinical Trial

Abstract

Background:

Hypertension and Diabetes Mellitus (DM) are prevalent chronic conditions and major risk factors for cardiovascular diseases. Adequate control of these conditions is challenging, and lifestyle changes are crucial to achieving better management.

Objectives:

To evaluate the effectiveness of a multifaceted and multidisciplinary intervention to improve the control of hypertension and DM in the primary care setting.

Methods:

This cluster randomized clinical trial focuses on lifestyle modifications for managing hypertension and DM, addressing gaps in current non-pharmacological interventions. Primary care professionals are trained to promote health education on physical activity and nutrition. Support is provided through a telementoring program, including messaging app communication, biweekly online meetings (teletutoring), and asynchronous teleconsultations. Primary care professionals conduct twice-weekly group activities with structured intensity adjustments and biweekly health education sessions using interactive methods like conversations, games, and group dynamics. For patients unable to join group activities, brief counseling and guidance on unsupervised physical activity are offered.

Results:

The primary outcomes are blood pressure and glycated hemoglobin values. The innovative intervention program aims to empower primary care professionals and reduce barriers to care through lifestyle changes, improved health education, and support systems for both supervised and unsupervised interventions. Conclusions: Supporting primary care professionals through education and remote assistance can enhance the effectiveness of lifestyle interventions, contributing significantly to the control of hypertension and DM in primary care settings. Trial registration: Previously registered with .