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Randomized Controlled Trial
. 2013 Dec;55(6):595-606.
doi: 10.21149/spm.v55i6.7305.

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

Sonia Hernández-Cordero  1 , Dinorah González-Castell  2 , Sonia Rodríguez-Ramírez  2 , María Ángeles Villanueva-Borbolla  2 , Mishel Unar  2 , Simón Barquera  2 , Teresita González de Cossío  2 , Juan Rivera-Dommarco  2 , Barry M Popkin  3
Affiliations
Randomized Controlled Trial

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

Sonia Hernández-Cordero et al. Salud Publica Mex. 2013 Dec.

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.

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Conflict of interest statement

Declaration of conflict of interests. The authors declare that they have no conflict of interests.

Figures

Figure 1
Figure 1. Flow of participants through the trial
*Based on attendance at last appointment ‡All subjects, except one of the EP group, had waist circumference measurement, thus comparison between groups for that measurement was done in 119 subjects in the EP group
See this image and copyright information in PMC

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