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.


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.
Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México, 62100, cordero@insp.mx.
Sonia
S
Hernández-Cordero
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Dinorah
D
González-Castell
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Sonia
S
Rodríguez-Ramírez
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
María Ángeles
MÁ
Villanueva-Borbolla
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Mishel
M
Unar
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Simón
S
Barquera
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Teresita
T
González de Cossío
Centro de Investigación en Nutrición y Salud, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, México.
Juan
J
Rivera-Dommarco
University of North Carolina, NC, USA.
Barry M
BM
Popkin
D000293:Adolescent; D000328:Adult; D004326:Drinking; D005260:Female; D006801:Humans; D024821:Metabolic Syndrome / Q000517:prevention & control*; D008800:Mexico; D008875:Middle Aged; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012307:Risk Factors; D055815:Young Adult