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

February 17, 2025 updated by: Gabriela Iveth Martínez Figueroa, Universidad Autonoma de Nuevo Leon

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Hospital Universitario Dr. José Eleuterio González

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tummy Time Group
This group will receive the 12-week intervention, which will have follow-up measurements during the implementation of the intervention.
Behavioral: Tummy Time for the prevention of childhood obesity

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.
No Intervention: Hospital Group
This group receives the usual hospital care where the mother is provided with general information on breastfeeding, vaccination and infant screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increased practice of tummy time in infants
Time Frame: It will be measured at baseline, 3 and 6 months.
The diary is made up of 15 items aimed at measuring whether the activity is applied, frequency with which it is performed, duration in each frequency and total duration of the activity within 24 hours, it is made up of open responses and must be answered according to the last week prior to the application of the instrument. The interpretation is made for each item and is compared with the recommendations given in the guidelines of international organizations (PAHO, 2019), the results are presented in a comparison to determine whether or not the recommendations given are complied with.
It will be measured at baseline, 3 and 6 months.
Maintenance of healthy weight in the infant
Time Frame: It will be measured at baseline, at 3 and 6 months of age of the infant.
, the infant growth patterns in children under two years of age will be used, where the anthropometric measurements of infants during birth will be used and in the follow-up measurements self-reported by the mother, the data will be analyzed through the free access computer program Anthro ® of the WHO (2024) that allows calculating through the indicators of weight/length and BMI/age the nutritional status of the infant and be classified using the z-scores: malnutrition (≤ -2 SD); normal (≥ -1 and ≤ 1 SD); SP (> 1 and ≤ 2 DE) and OB (≥ 2 DE).
It will be measured at baseline, at 3 and 6 months of age of the infant.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increasing mothers' knowledge of developmental milestones
Time Frame: It will be measured at baseline, at 3 and 6 months
The questionnaire "parents' knowledge of developmental milestones in children", developed and validated by Rickhy et al. (2010) in English, will be used, which aims to assess parents' knowledge about the time in which their children should achieve different skills. It consists of 17 questions distributed in five dimensions: 1) physical development (1, 2, 3 and 4); 2) cognitive development (5, 6 and 7); 3) social development (8, 9, 10, 11 and 12) and 4) and emotional development (13, 14, 15, 16 and 17), with a dichotomous response scale of 1= true, 2= false. For interpretation, the answers are graded at 1 = correct and 0 = incorrect, the score ranges from 0 to 17 points, it being understood that the higher the score, the higher the level of knowledge the parents have.
It will be measured at baseline, at 3 and 6 months
Increased knowledge of tummy time
Time Frame: Measured at baseline, 3 months and 6 months
The questionnaire "knowledge, beliefs and implementation on the prone position" This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, the first dimension measures knowledge about TT, it is made up of nine questions that are answered on a dichotomous scale of 1= true; 2= false, presented a Cronbach's alpha reliability of .67. For their interpretation, the questions are evaluated and transformed into 1= correct; 0= incorrect, the score ranges from 0 to 9 points, where it is interpreted that the higher the score, the higher the level of knowledge about TT the parents have.
Measured at baseline, 3 months and 6 months
Positive and negative beliefs about tummy time
Time Frame: Measured at baseline, 3 months and 6 months
The questionnaire knowledge, beliefs and implementation on the prone position. This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, The second dimension assesses parents' beliefs about TT is made up of 18 items with a five-point Likert-type response scale (1=strongly disagree, 2=disagree, 3=neither disagree nor agree, 4=agree and 5=strongly agree), is subdivided into positive beliefs (10, 11, 12, 13, 14, 15, 16, 17, and 18) and negative beliefs (1, 2, 3, 4, 5, 6, 7, 8, and 9), the questionnaire as a whole presented a Cronbach's alpha reliability of .45 in the original language; The total score ranges from 18 to 90 points, it is interpreted that the higher the score, the higher the level of positive and/or negative beliefs
Measured at baseline, 3 months and 6 months
increased implementation of tummy time
Time Frame: Measured at baseline, 3 months and 6 months
The questionnaire knowledge, beliefs and implementation on the prone position. This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, dimension three evaluates the factors, frequency and duration of TT in the infant, it is made up of 11 items with a multiple response scale for each item, the interpretation is descriptive per item.
Measured at baseline, 3 months and 6 months
Maternal Perception of Child's Weight
Time Frame: will be measured at baseline, 3 months and 6 months
It is made up of an item of: "I think my child is" with a multiple choice of: underweight, a little underweight, more or less with the correct weight, with a little SP and with SP, it is also evaluated with a panel of five images according to the sex of the child, in which the mother must select two things: 1) the image that best represents the weight of her child and 2) the image that represents a healthy child. The selection of the answers will determine the mother's perception of her child's weight and a healthy weight.
will be measured at baseline, 3 months and 6 months
Child Behavior
Time Frame: will be measured at baseline, 3 months and 6 months

the questionnaire aims to measure infant temperament as a sign of the frequency in which the infant presents the behavior during a week prior to application. It is composed of 37 items with a 7-point Likert-type response scale ranging from 1= never to 7= always, and is divided into three dimensions. For the interpretation, item 11 evaluates inversely, a sum of the total of the items is made, where the total score ranges from 37 to 259 points, it is considered that, the higher the score, the greater the characteristic of infant temperament as a function of the three dimensions.

Likewise, a subscale of "calming techniques" is presented, which aims to determine which techniques the mother has used to calm her child in the last two weeks, it is composed of 11 items with a 7-point Likert-type response scale ranging from 1= none to 7= always. The interpretation is carried out in a descriptive way of each item.
will be measured at baseline, 3 months and 6 months
increased mother's self-confidence in child rearing
Time Frame: will be measured at baseline, 3 months and 6 months
the "Karitane Parental Confidence Scale". It is composed of three dimensions of: 1) perceptions of parenting capacity; 2) available parenting support and 3) perceptions of child development. It is made up of a total of 15 items with a four-point Likert-type response scale of: 0 = No, almost never, 1 = No, not very often, 2 = Yes, sometimes, 3 = Yes, most of the time, with a range of scores from 0 to 45 maximum. The interpretation is made with the total sum of the items, where the higher the score, the higher the level of self-efficacy perceived by the parents for upbringing, in addition cohorts are presented according to the score where they have: severe clinical range (31 or less); moderate clinical range (31-35); mild clinical range (36-39) and no clinical range (40 or more).
will be measured at baseline, 3 months and 6 months
Perceived Parental Self-Efficacy for Physical Activity Behaviors
Time Frame: will be measured at baseline, 3 months and 6 months
the questionnaire "perceived parental self-efficacy on dietary and physical activity behavior", developed and validated by Bohman et al. (2013) in its English version. It is made up of 14 items that are subdivided into two dimensions: 1) self-efficacy for dietary behaviors (1, 2, 3, 4, 5, 6 and 7) and 2) self-efficacy for physical activity behaviors (8, 9, 10, 11, 12, 13 and 14), an 11-point Likert-type response scale ranging from 0= nothing to 10= to a very high degree, with a score ranging from 0 to 140, it is interpreted that, the higher the score, the greater the parents' perception of self-efficacy. It has presented reliability through Cronbach's alpha coefficient of .88.
will be measured at baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de Nuevo Leon

Collaborators

Universidad de la Sabana

Investigators

  • Study Chair: Gloria Carvajal Carrascal, PhD, Universidad de La Sabana
  • Study Director: Velia M Cárdenas Villarreal, PhD, Universidad Autonoma de Nuevo Leon
  • Study Chair: Jorge A Mayo Abarca, Master, Universidad Autonoma de Nuevo Leon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Actual)

December 14, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAEN-D-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not due to the protection of participant confidentiality given by informed consent. Statistical data only.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prevention and Control

Clinical Trials on Tummy Time for the prevention of childhood obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe