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NCT06616467N/AActiveUpdate OverdueUpdated 16mo ago · Completion was 18mo agoCognitive-Behavioral Intervention Targeting Mothers to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
In Brief
A clinical study evaluating Tummy Time for the prevention of childhood obesity for Obesity/therapy and Prevention and Control. Active but no longer recruiting, targeting 144 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Interventions
A cognitive-behavioral intervention aimed at mothers of infants is presented that aims to increase the practice of TT and maintain a healthy weight in the infant, called \"Tummy Time for the prevention of childhood obesity\", within the intervention modifiable variables are involved that directly impact the expected results such as: the knowledge and beliefs of the mothers, infant temperament, parental self-efficacy and self-efficacy for the practice of TT. The intervention lasts 12 weeks from the first contact with the participants and consists of eight sessions broken down as follows: the first session is presented in a face-to-face format with expository, audiovisual and demonstrative means; sessions two, four, five and seven are provided through a text message with use WhatsApp® and the use of visual media. Sessions three, six and eight are delivered via telephone call with the aim of offering feedback on the doubts generated up to that point.