BACKGROUND: Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children < 5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. METHODS: We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2 to 5 years old with WHO body mass index (BMI) z-score 0 to 3. We measured children's height and weight and parents reported children's diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. RESULTS: 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention versus usual care children increased vegetables by 6.3 servings/week (95% CI 1.8 to 10.8). In stratified analyses, intervention participants with high program adherence (5 to 6 sessions) decreased snacks and screen time and increased vegetables versus usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. CONCLUSIONS: Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. TRIAL REGISTRATION: ClinicalTrials.gov NCT01539070. Comision Nacional de Investigacion Cientifica del IMSS: 2009-785-120.

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