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.
RCT Entities:
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.
Authors: Simon Barquera; Lucia Hernandez-Barrera; Maria Lizbeth Tolentino; Juan Espinosa; Shu Wen Ng; Juan A Rivera; Barry M Popkin Journal: J Nutr Date: 2008-12 Impact factor: 4.798
Authors: Liwei Chen; Lawrence J Appel; Catherine Loria; Pao-Hwa Lin; Catherine M Champagne; Patricia J Elmer; Jamy D Ard; Diane Mitchell; Bryan C Batch; Laura P Svetkey; Benjamin Caballero Journal: Am J Clin Nutr Date: 2009-04-01 Impact factor: 7.045
Authors: Majken K Jensen; Anne T Andersen; Thorkild I A Sørensen; Ulrik Becker; Thorkil Thorsen; Morten Grønbaek Journal: Epidemiology Date: 2002-03 Impact factor: 4.822
Authors: Carlos A Aguilar-Salinas; Francisco J Gómez-Pérez; Juan Rull; Salvador Villalpando; Simón Barquera; Rosalba Rojas Journal: Salud Publica Mex Date: 2010
Authors: Jodi D Stookey; Florence Constant; Barry M Popkin; Christopher D Gardner Journal: Obesity (Silver Spring) Date: 2008-09-11 Impact factor: 5.002
Authors: Peter von Philipsborn; Jan M Stratil; Jacob Burns; Laura K Busert; Lisa M Pfadenhauer; Stephanie Polus; Christina Holzapfel; Hans Hauner; Eva Rehfuess Journal: Cochrane Database Syst Rev Date: 2019-06-12