Design and challenges of a randomized controlled trial for reducing risk factors of metabolic syndrome in Mexican women through water intake / Diseño y retos de un ensayo clínico aleatorizado para reducir el riesgo de síndrome metabólico en mujeres mexicanas mediante consumo de agua

Objective. To describe the design, methods, and challenges encountered during a randomized clinical trial aimed to promote water intake for reducing risks of metabolic syndrome in Mexican women. Materials and methods. In a randomized clinical trial in Cuernavaca, Mexico, overweight and obese (body mass index [BMI] ≥ 25 < 39) women, 18 - < 45 years old with an intake of sugar-sweetened beverages ≥ 250 kilocalories per day (kcal/day) were randomly allocated to the water and education provision group (n = 120) or the education provision only group (n = 120). Results. We screened 1 756 women. The main difficulties encountered were identifying participants with the recruitment criteria, delivering water to participants, and the time demanded from the study participants. Conclusions. The trial's main challenges were difficulties surrounding recruitment, delivery of the intervention, and the time demanded from the study participants. Modifications were effectively implemented without jeopardizing the original protocol.

Objetivo. Describir el diseño, métodos y dificultades logísticas enfrentadas durante un ensayo clínico aleatorizado con el objetivo de promover el aumento en el consumo de agua para reducir el riesgo metabólico en mujeres obesas. Material y métodos. Ensayo clínico aleatorizado, desarrollado en Cuernavaca, México. Mujeres con IMC ≥ 25 y < 39, entre 18 y < 45 años, con consumo de bebidas azucaradas ≥ 250 kcal/día, se asignaron aleatoriamente a a) grupo de agua y educación nutricional (n = 120), o b) educación nutricional únicamente (n = 120). Resultados. Se realizaron pruebas de tamizaje a 1 756 mujeres. Las principales dificultades para el desarrollo del estudio fueron identificar participantes que cumplieran criterios del estudio, entrega de agua y tiempo invertido por las participantes en actividades del proyecto. Conclusiones. Los retos del proyecto estuvieron relacionados con el reclutamiento, entrega de la intervención y demanda de tiempo a las participantes. Se implementaron modificaciones sin afectar la validez del estudio.

Design and challenges of a randomized controlled trial for reducing risk factors of metabolic syndrome in Mexican women through water intake.

OBJECTIVE: To describe the design, methods, and challenges encountered during a randomized clinical trial aimed to promote water intake for reducing risks of metabolic syndrome in Mexican women. MATERIALS AND METHODS: In a randomized clinical trial in Cuernavaca, Mexico, overweight and obese (body mass index [BMI] ≥ 25 < 39) women, 18 - < 45 years old with an intake of sugar-sweetened beverages ≥ 250 kilocalories per day (kcal/day) were randomly allocated to the water and education provision group (n = 120) or the education provision only group (n = 120). RESULTS: We screened 1 756 women. The main difficulties encountered were identifying participants with the recruitment criteria, delivering water to participants, and the time demanded from the study participants. CONCLUSIONS: The trial's main challenges were difficulties surrounding recruitment, delivery of the intervention, and the time demanded from the study participants. Modifications were effectively implemented without jeopardizing the original protocol.