Design and Challenges of a Randomized Controlled Trial for Reducing Risk Factors of Metabolic Syndrome in Mexican Women through Water Intake

Citation

Hernández-Cordero, Sonia; González-Castell, Dinorah; Rodríguez-Ramírez, Sonia; Villanueva-Borbolla, Maria Angeles; Unar, Mishel; Barquera, Simon; González de Cosío, Teresita; Rivera-Dommarco, Juan; & Popkin, Barry M. (2013). Design and Challenges of a Randomized Controlled Trial for Reducing Risk Factors of Metabolic Syndrome in Mexican Women through Water Intake. Salud Pública de México, 55(6), 595-606. PMCID: PMC4282722

Abstract

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.

URL

http://www.redalyc.org/articulo.oa?id=10628941006

Reference Type

Journal Article

Year Published

2013

Journal Title

Salud Pública de México

Author(s)

Hernández-Cordero, Sonia
González-Castell, Dinorah
Rodríguez-Ramírez, Sonia
Villanueva-Borbolla, Maria Angeles
Unar, Mishel
Barquera, Simon
González de Cosío, Teresita
Rivera-Dommarco, Juan
Popkin, Barry M.

PMCID

PMC4282722

ORCiD

Popkin - 0000-0001-9495-9324