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Active Not RecruitingNCT06616467

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

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
144 (estimated)
Sponsor
Universidad Autonoma de Nuevo Leon · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTummy Time for the prevention of childhood obesityA 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.

Timeline

Start date
2024-09-02
Primary completion
2024-12-14
Completion
2025-08-01
First posted
2024-09-27
Last updated
2025-02-20

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT06616467. Inclusion in this directory is not an endorsement.