Sustainability of mHealth Effects on Cardiometabolic Risk Factors: Five-Year Results of a Randomized Clinical Trial (Preprint)

BACKGROUND The long-term effects of mobile health (mHealth) interventions have not been documented, especially in resource-constrained settings. OBJECTIVE This study aimed to assess the effects of a 1-year mHealth intervention on blood pressure levels and body weight in low-resource urban settings in Peru, 4 years after the completion of the original study. METHODS Four years after the original Grupo de Investigación en Salud Móvil en America Latina (GISMAL) study, we attempted to contact the 212 individuals originally enrolled in the study in Peru. The primary outcomes were systolic and diastolic blood pressure levels and hypertension incidence. Secondary outcome measures were body weight, BMI, and self-reported target behaviors. The study personnel collecting the data were masked to the group assignment. Linear mixed models were used to evaluate the effects of the intervention on primary and secondary outcomes in an intention-to-treat analysis. RESULTS Data from 164 (77.4%) of the 212 originally enrolled participants were available and analyzed (80 in the intervention group and 84 in the control group). The intervention did not result in changes in systolic (–2.54 mm Hg, 95% CI –8.23 to 3.15) or diastolic (3.41 mm Hg, 95% CI –0.75 to 7.57) blood pressure compared with the control group. The intervention reduced the risk of developing hypertension, but the result was not significant (risk ratio (RR) 0.76, 95% CI 0.45-1.28). However, those who received the intervention had lower body weight (–5.42 kg, 95% CI –10.4 to –0.48) and BMI (–2.56 kg/m2, 95% CI –4.46 to –0.66). In addition, compared to the control participants, those who received ≥50% of the scheduled calls during the intervention had greater reductions in body weight (–6.23 kg, 95% CI –11.47 to –0.99) and BMI (–2.81 kg/m2, 95% CI –4.77 to –0.85). CONCLUSIONS An mHealth intervention comprising motivational interview calls and SMS text messaging appears to have effects on health 4 years after intervention completion. Although there were no effects on blood pressure levels, important reductions in body weight and BMI were seen 5 years after randomization. Thus, mHealth appears to be a promising preventive strategy for noncommunicable diseases in resource-constrained settings. CLINICALTRIAL Clinicaltrials.gov NCT01295216; https://clinicaltrials.gov/ct2/show/NCT01295216