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

U

Universidad Autonoma de Nuevo Leon

Status

Active, not recruiting

Conditions

Prevention and Control
Obesity/therapy

Treatments

Behavioral: Tummy Time for the prevention of childhood obesity

Study type

Interventional

Funder types

Other

Identifiers

NCT06616467
FAEN-D-2016

Details and patient eligibility

About

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.

Enrollment

144 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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 <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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

144 participants in 2 patient groups

Tummy Time Group
Experimental group
Description:
This group will receive the 12-week intervention, which will have follow-up measurements during the implementation of the intervention.
Treatment:
Behavioral: Tummy Time for the prevention of childhood obesity
Hospital Group
No Intervention group
Description:
This group receives the usual hospital care where the mother is provided with general information on breastfeeding, vaccination and infant screening.

Trial contacts and locations

1

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Central trial contact

Jorge A Mayo Abarca, Master; Gabriela I Martínez Figueroa, Master

Data sourced from clinicaltrials.gov

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