Implementation Tells Us More Beyond Pooled Estimates: Secondary Analysis of a Multicountry mHealth Trial to Reduce Blood Pressure

Rodrigo M Carrillo-Larco, Safia S Jiwani, Francisco Diez-Canseco, Rebecca Kanter, Andrea Beratarrechea, Vilma Irazola, Manuel Ramirez-Zea, Adolfo Rubinstein, Homero Martinez, J Jaime Miranda, GISMAL Group, Adrían Alasino, Berneth Nuris Budiel Moscoso, Carolina Carrara, Jackelyn Espinoza Surichaqui, Gimena Giardini, Jesica Guevara, Analí Morales Juárez, Lorena Lázaro Cuesta, Dalia Lewitan, Lita Palomares Estrada, Carla Martínez Ramírez, Gloria Robles de la Cruz, Julissa Salguero, Juan Carlos Saravia Drago, María Urtasún, José Alfredo Zavala Loayza, Rodrigo M Carrillo-Larco, Safia S Jiwani, Francisco Diez-Canseco, Rebecca Kanter, Andrea Beratarrechea, Vilma Irazola, Manuel Ramirez-Zea, Adolfo Rubinstein, Homero Martinez, J Jaime Miranda, GISMAL Group, Adrían Alasino, Berneth Nuris Budiel Moscoso, Carolina Carrara, Jackelyn Espinoza Surichaqui, Gimena Giardini, Jesica Guevara, Analí Morales Juárez, Lorena Lázaro Cuesta, Dalia Lewitan, Lita Palomares Estrada, Carla Martínez Ramírez, Gloria Robles de la Cruz, Julissa Salguero, Juan Carlos Saravia Drago, María Urtasún, José Alfredo Zavala Loayza

Abstract

Background: The uptake of an intervention aimed at improving health-related lifestyles may be influenced by the participant's stage of readiness to change behaviors.

Objective: We conducted secondary analysis of the Grupo de Investigación en Salud Móvil en América Latina (GISMAL) trial according to levels of uptake of intervention (dose-response) to explore outcomes by country, in order to verify the consistency of the trial's pooled results, and by each participant's stage of readiness to change a given lifestyle at baseline. The rationale for this secondary analysis is motivated by the original design of the GISMAL study that was independently powered for the primary outcome-blood pressure-for each country.

Methods: We conducted a secondary analysis of a mobile health (mHealth) multicountry trial conducted in Argentina, Guatemala, and Peru. The intervention consisted of monthly motivational phone calls by a trained nutritionist and weekly tailored text messages (short message service), over a 12-month period, aimed to enact change on 4 health-related behaviors: salt added to foods when cooking, consumption of high-fat and high-sugar foods, consumption of fruits or vegetables, and practice of physical activity. Results were stratified by country and by participants' stage of readiness to change (precontemplation or contemplation; preparation or action; or maintenance) at baseline. Exposure (intervention uptake) was the level of intervention (<50%, 50%-74%, and ≥75%) received by the participant in terms of phone calls. Linear regressions were performed to model the outcomes of interest, presented as standardized mean values of the following: blood pressure, body weight, body mass index, waist circumference, physical activity, and the 4 health-related behaviors.

Results: For each outcome of interest, considering the intervention uptake, the magnitude and direction of the intervention effect differed by country and by participants' stage of readiness to change at baseline. Among those in the high intervention uptake category, reductions in systolic blood pressure were only achieved in Peru, whereas fruit and vegetable consumption also showed reductions among those who were at the maintenance stage at baseline in Argentina and Guatemala.

Conclusions: Designing interventions oriented toward improving health-related lifestyle behaviors may benefit from recognizing baseline readiness to change and issues in implementation uptake.

Trial registration: ClinicalTrials.gov NCT01295216; https://ichgcp.net/clinical-trials-registry/NCT01295216 (Archived by WebCite at http://www.webcitation.org/72tMF0B7B).

Keywords: Argentina; Guatemala; Peru; behavior; clinical trial; health risk behaviors, lifestyle risk reduction; mHealth.

Conflict of interest statement

Conflicts of Interest: None declared.

©Rodrigo M Carrillo-Larco, Safia S Jiwani, Francisco Diez-Canseco, Rebecca Kanter, Andrea Beratarrechea, Vilma Irazola, Manuel Ramirez-Zea, Adolfo Rubinstein, Homero Martinez, J Jaime Miranda, GISMAL Group. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 01.11.2018.

Figures

Figure 1
Figure 1
Assessed outcomes of subjects who received ≥75% of the intervention overall and by country. BMI: body mass index.
Figure 2
Figure 2
Intervention effect on salt added when cooking according to participant baseline stage of readiness status, overall and by country. Pre-Con/Con: precontemplation or contemplation; Prep/Act: preparation or action; Maint: maintenance.
Figure 3
Figure 3
Intervention effect on fruit and vegetable consumption according to the participant baseline readiness to change status, overall and by country. Pre-Con/Con: precontemplation or contemplation; Prep/Act: preparation or action; Maint: maintenance.

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Source: PubMed

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