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Obesity/therapyNCT06616467

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

A study testing Tummy Time for the prevention of childhood obesity in people with Obesity/therapy and Prevention and Control, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity/therapy, Prevention and Control
What is being tested?
Tummy Time for the prevention of childhood obesity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteMexico
Study dates
2 Sep 2024to Aug 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

Other trials in Mexico

About this study

Official title: 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.

Being tested
Tummy Time for the prevention of childhood obesity
Keywords
Infants, Prone position, Health Behavior, Mothers
Medical subject headings
Obesity, Health Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tummy Time for the prevention of childhood obesityBehavioural

    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.

Study groups in NCT06616467
Study groupRoleWhat they receive
Tummy Time GroupExperimentalThis group will receive the 12-week intervention, which will have follow-up measurements during the implementation of the intervention.
Receives: Behavioral: Tummy Time for the prevention of childhood obesity
Hospital GroupNo interventionThis group receives the usual hospital care where the mother is provided with general information on breastfeeding, vaccination and infant screening.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increased practice of tummy time in infants

    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.

    Measured: It will be measured at baseline, 3 and 6 months.

  2. Maintenance of healthy weight in 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).

    Measured: It will be measured at baseline, at 3 and 6 months of age of the infant.

Secondary outcomes (8)

  1. increasing mothers' knowledge of developmental milestones

    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.

    Measured: It will be measured at baseline, at 3 and 6 months

  2. Increased knowledge of tummy time

    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: Measured at baseline, 3 months and 6 months

  3. Positive and negative beliefs about tummy time

    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: Measured at baseline, 3 months and 6 months

  4. increased implementation of tummy time

    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: Measured at baseline, 3 months and 6 months

  5. Maternal Perception of Child's Weight

    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.

    Measured: will be measured at baseline, 3 months and 6 months

  6. Child Behavior

    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.

    Measured: will be measured at baseline, 3 months and 6 months

  7. increased mother's self-confidence in child rearing

    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).

    Measured: will be measured at baseline, 3 months and 6 months

  8. Perceived Parental Self-Efficacy for Physical Activity Behaviors

    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.

    Measured: will be measured at baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2024
  2. Study start2 Sep 2024
  3. Primary completion14 Dec 2024
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The present research will be a phase II intervention study (Gitlin \& 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 \& Burns, 2015).
Masking
Single blind
Who is masked
Participant
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06616467
Sponsor's protocol ID
FAEN-D-2016
Status last verified
Feb 2025
First submitted
24 Sep 2024
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not due to the protection of participant confidentiality given by informed consent. Statistical data only.

Publications

  • Taylor BJ, Heath AL, Galland BC, Gray AR, Lawrence JA, Sayers RM, Dale K, Coppell KJ, Taylor RW. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth. BMC Public Health. 2011 Dec 19;11:942. doi: 10.1186/1471-2458-11-942.

    PubMed 22182309

  • Taj F, Klein MCA, van Halteren A. Digital Health Behavior Change Technology: Bibliometric and Scoping Review of Two Decades of Research. JMIR Mhealth Uhealth. 2019 Dec 13;7(12):e13311. doi: 10.2196/13311.

    PubMed 31833836

  • Rosenstock S, Ingalls A, Foy Cuddy R, Neault N, Littlepage S, Cohoe L, Nelson L, Shephard-Yazzie K, Yazzie S, Alikhani A, Reid R, Kenney A, Barlow A. Effect of a Home-Visiting Intervention to Reduce Early Childhood Obesity Among Native American Children: A Randomized Clinical Trial. JAMA Pediatr. 2021 Feb 1;175(2):133-142. doi: 10.1001/jamapediatrics.2020.3557.

    PubMed 33165594

  • Rikhy S, Tough S, Trute B, Benzies K, Kehler H, Johnston DW. Gauging knowledge of developmental milestones among Albertan adults: a cross-sectional survey. BMC Public Health. 2010 Apr 8;10(1):183. doi: 10.1186/1471-2458-10-183.

    PubMed 20377910

  • Putnam SP, Helbig AL, Gartstein MA, Rothbart MK, Leerkes E. Development and assessment of short and very short forms of the infant behavior questionnaire-revised. J Pers Assess. 2014;96(4):445-58. doi: 10.1080/00223891.2013.841171. Epub 2013 Nov 9.

    PubMed 24206185

  • Poitras VJ, Gray CE, Janssen X, Aubert S, Carson V, Faulkner G, Goldfield GS, Reilly JJ, Sampson M, Tremblay MS. Systematic review of the relationships between sedentary behaviour and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):868. doi: 10.1186/s12889-017-4849-8.

    PubMed 29219092

  • Perez-Herrera A, Cruz-Lopez M. [Childhood obesity: current situation in Mexico]. Nutr Hosp. 2019 Apr 10;36(2):463-469. doi: 10.20960/nh.2116. Spanish.

    PubMed 30866635

  • Paul IM, Savage JS, Anzman-Frasca S, Marini ME, Beiler JS, Hess LB, Loken E, Birch LL. Effect of a Responsive Parenting Educational Intervention on Childhood Weight Outcomes at 3 Years of Age: The INSIGHT Randomized Clinical Trial. JAMA. 2018 Aug 7;320(5):461-468. doi: 10.1001/jama.2018.9432.

    PubMed 30088009

  • Palmer CF, Rindler D, Leverone B. Moving into tummy time, together: Touch and transitions aid parent confidence and infant development. Infant Ment Health J. 2019 Mar;40(2):277-288. doi: 10.1002/imhj.21771. Epub 2019 Jan 25.

    PubMed 30681173

  • Nitsos A, Estrada RD, Messias DKH. Tummy Time for Latinos With Limited English Proficiency: Evaluating the Feasibility of a Cultural and Linguistically Adapted Parent Education Intervention. J Pediatr Nurs. 2017 Sep-Oct;36:31-36. doi: 10.1016/j.pedn.2017.04.004. Epub 2017 May 17.

    PubMed 28888509

  • Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011 Nov;26(11):1479-98. doi: 10.1080/08870446.2010.540664. Epub 2011 Jun 28.

    PubMed 21678185

  • Michie S, Yardley L, West R, Patrick K, Greaves F. Developing and Evaluating Digital Interventions to Promote Behavior Change in Health and Health Care: Recommendations Resulting From an International Workshop. J Med Internet Res. 2017 Jun 29;19(6):e232. doi: 10.2196/jmir.7126.

    PubMed 28663162

  • McMillan AG, May LE, Gaines GG, Isler C, Kuehn D. Effects of Aerobic Exercise during Pregnancy on 1-Month Infant Neuromotor Skills. Med Sci Sports Exerc. 2019 Aug;51(8):1671-1676. doi: 10.1249/MSS.0000000000001958.

    PubMed 30817721

  • McEachan RRC, Santorelli G, Bryant M, Sahota P, Farrar D, Small N, Akhtar S, Sargent J, Barber SE, Taylor N, Richardson G, Farrin AJ, Bhopal RS, Bingham DD, Ahern SM, Wright J; BiB childhood obesity scientific group. The HAPPY (Healthy and Active Parenting Programmme for early Years) feasibility randomised control trial: acceptability and feasibility of an intervention to reduce infant obesity. BMC Public Health. 2016 Mar 1;16:211. doi: 10.1186/s12889-016-2861-z.

    PubMed 26931491

  • Mailhot T, Goulet MH, Maheu-Cadotte MA, Fontaine G, Lequin P, Lavoie P. Methodological reporting in feasibility studies: a descriptive review of the nursing intervention research literature. J Res Nurs. 2020 Aug;25(5):460-472. doi: 10.1177/1744987119883404. Epub 2019 Nov 26.

    PubMed 34394661

Questions about this trial

What is this clinical trial studying?

A study testing Tummy Time for the prevention of childhood obesity in people with Obesity/therapy and Prevention and Control, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Increased practice of tummy time in infants (time frame: It will be measured at baseline, 3 and 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616467, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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