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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary completion date changed from estimate of Apr 2025 to Dec 14, 2024
    • Study completion date: Jul 2025 to Aug 2025
    • Eligibility criteria shortened, about 37 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06616467
Lead Sponsor Universidad Autonoma de Nuevo Leon
Collaborators: Universidad de la Sabana
Conditions
(from sponsor)
Obesity/therapy, Prevention and Control
Related terms Health Behavior, Obesity
Enrollment 144 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov