Clinical Trial

Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants

Active, Not Recruiting
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Summary
Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-24.
Status change: Recruiting → Active, Not Recruiting 2025-02-17
Trial Details
NCT Number NCT06616467
Lead Sponsor Universidad Autonoma de Nuevo Leon
Collaborators: Universidad de la Sabana
Conditions Obesity/therapy, Prevention and Control
Enrollment 144 participants
Start Date 2024-09-02
Primary Completion 2024-12-14 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2025-02-20