Clinical trial NCT06616467: Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
Official title: Cognitive-Behavioral Intervention Targeting Mothers to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity/therapy
Prevention and Control
Keywords: Infants
Prone position
Health Behavior
Mothers
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: Universidad de la Sabana
First posted: 2024-09-27
Enrollment: 144
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present research will be a phase II intervention study (Gitlin \&amp; Czaja, 2016), of the Pilot Randomized Clinical Trial (RCT) type, because it is intended to manipulate the independent variable that will be the intervention that integrates the components of: knowledge, beliefs, infant temperament, self-efficacy and sedentary practices, to measure the effect on the variables dependent on Tummy Time practice practice and healthy weight control. The Experimental Group (EG) and Control Group (CG) will be randomized, the intervention will be with a single-blind approach and repeated measurements (Grove \&amp; Burns, 2015).
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Mother-child dyads that are in the postpartum
* mothers who declare that they know how to read and write in spanish
* have an electronic device (cell phone, tablet or computer),
* have an internet connection.
* Have the social network WhatsApp®
* Agree to participate voluntarily evidenced by informed consent will be considered

Exclusion Criteria:

* Women who report having received information about TT one month before the intervention.
* Women who are actively participating in programs related to early stimulation
* Who declare that they have a premature infant born before 37 SDG,
* who has a low birth weight \&lt;2,500g,
* who has a medical condition or complication at birth that impacts their physical mobility and
* who has chronic health problems or congenital anomalies.

Primary outcomes:
measure: Increased practice of tummy time in infants
timeFrame: It will be measured at baseline, 3 and 6 months.
measure: Maintenance of healthy weight in the infant
timeFrame: It will be measured at baseline, at 3 and 6 months of age of the infant.
Secondary outcomes:
measure: increasing mothers&#39; knowledge of developmental milestones
timeFrame: It will be measured at baseline, at 3 and 6 months
measure: Increased knowledge of tummy time
timeFrame: Measured at baseline, 3 months and 6 months
measure: Positive and negative beliefs about tummy time
timeFrame: Measured at baseline, 3 months and 6 months
measure: increased implementation of tummy time
timeFrame: Measured at baseline, 3 months and 6 months
measure: Maternal Perception of Child&#39;s Weight
timeFrame: will be measured at baseline, 3 months and 6 months
measure: Child Behavior
timeFrame: will be measured at baseline, 3 months and 6 months
measure: increased mother&#39;s self-confidence in child rearing
timeFrame: will be measured at baseline, 3 months and 6 months
measure: Perceived Parental Self-Efficacy for Physical Activity Behaviors
timeFrame: will be measured at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Nuevo León
Study officials:
affiliation: Universidad Autonoma de Nuevo León
name: Velia M Cárdenas Villarreal, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Autonoma de Nuevo León
name: Jorge A Mayo Abarca, Master
role: STUDY_CHAIR
affiliation: Universidad de la Sabana
name: Gloria Carvajal Carrascal, PhD
role: STUDY_CHAIR
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