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

NCT06616467 | Active Not Recruiting

• 1 other identifier: FAEN-D-2016
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity/therapy; Prevention and Control

Keywords

Infants; Prone position; Health Behavior; Mothers

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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).

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

Secondary Outcomes (8)

• increasing mothers' knowledge of developmental milestones

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

• Increased knowledge of tummy time

  Measured at baseline, 3 months and 6 months

• Positive and negative beliefs about tummy time

  Measured at baseline, 3 months and 6 months

• increased implementation of tummy time

  Measured at baseline, 3 months and 6 months

• Maternal Perception of Child's Weight

  will be measured at baseline, 3 months and 6 months

Study Arms (2)

Tummy Time Group

EXPERIMENTAL

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

Hospital Group

NO INTERVENTION

This group receives the usual hospital care where the mother is provided with general information on breastfeeding, vaccination and infant screening.

Interventions

Tummy Time for the prevention of childhood obesity BEHAVIORAL

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.

Tummy Time Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Universidad de la Sabana: collaborator

Study Sites (1)

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (48)

• 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.

  PMID: 22182309 BACKGROUND

• 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.

  PMID: 31833836 BACKGROUND

• 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.

  PMID: 33165594 BACKGROUND

• 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.

  PMID: 20377910 BACKGROUND

• 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.

  PMID: 24206185 BACKGROUND

• 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.

  PMID: 29219092 BACKGROUND

• 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.

  PMID: 30866635 BACKGROUND

• 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.

  PMID: 30088009 BACKGROUND

• 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.

  PMID: 30681173 BACKGROUND

• 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.

  PMID: 28888509 BACKGROUND

• 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.

  PMID: 21678185 BACKGROUND

• 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.

  PMID: 28663162 BACKGROUND

• 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.

  PMID: 30817721 BACKGROUND

• 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.

  PMID: 26931491 BACKGROUND

• 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.

  PMID: 34394661 BACKGROUND

• Lopez-Sobaler AM, Aparicio A, Salas-Gonzalez MD, Loria Kohen V, Bermejo Lopez LM. [Childhood obesity in Spain and associated factors]. Nutr Hosp. 2021 Sep 30;38(Spec No2):27-30. doi: 10.20960/nh.03793. Spanish.

  PMID: 34323095 BACKGROUND

• Koren A, Kahn-D'angelo L, Reece SM, Gore R. Examining Childhood Obesity From Infancy: The Relationship Between Tummy Time, Infant BMI-z, Weight Gain, and Motor Development-An Exploratory Study. J Pediatr Health Care. 2019 Jan;33(1):80-91. doi: 10.1016/j.pedhc.2018.06.006. Epub 2018 Aug 18.

  PMID: 30131199 BACKGROUND

• Korczak DJ, Madigan S, Colasanto M, Szatmari P, Chen Y, Maguire J, Parkin P, Birken CS. The longitudinal association between temperament and physical activity in young children. Prev Med. 2018 Jun;111:342-347. doi: 10.1016/j.ypmed.2017.11.021. Epub 2017 Nov 29.

  PMID: 29197529 BACKGROUND

• Kieslinger K, Wartha O, Pollatos O, Steinacker JM, Kobel S. Parental Self-Efficacy-A Predictor of Children's Health Behaviors? Its Impact on Children's Physical Activity and Screen Media Use and Potential Interaction Effect Within a Health Promotion Program. Front Psychol. 2021 Aug 12;12:712796. doi: 10.3389/fpsyg.2021.712796. eCollection 2021.

  PMID: 34456826 BACKGROUND

• Karimy M, Armoon B, Fayazi N, Koohestani HR. A Study on the Knowledge, Attitude, and Practices of Iranian Mothers towards Childhood Obesity. Obes Facts. 2019;12(6):669-677. doi: 10.1159/000492795. Epub 2019 Dec 16.

  PMID: 31842015 BACKGROUND

• Jones RE, Jewell J, Saksena R, Ramos Salas X, Breda J. Overweight and Obesity in Children under 5 Years: Surveillance Opportunities and Challenges for the WHO European Region. Front Public Health. 2017 Apr 13;5:58. doi: 10.3389/fpubh.2017.00058. eCollection 2017.

  PMID: 28451584 BACKGROUND

• Jia Z, Zhang J, Trindade D, Sobko T. Physical Activity Patterns and Correlates of 9-Month-Old Chinese Infants in the Macau Population. Matern Child Health J. 2018 Oct;22(10):1526-1533. doi: 10.1007/s10995-018-2614-y.

  PMID: 30094531 BACKGROUND

• Hewitt L, Kerr E, Stanley RM, Okely AD. Tummy Time and Infant Health Outcomes: A Systematic Review. Pediatrics. 2020 Jun;145(6):e20192168. doi: 10.1542/peds.2019-2168. Epub 2020 May 5.

  PMID: 32371428 BACKGROUND

• Hesketh KR, Janssen X. Movement behaviours and adherence to guidelines: perceptions of a sample of UK parents with children 0-18 months. Int J Behav Nutr Phys Act. 2022 May 21;19(1):58. doi: 10.1186/s12966-022-01300-5.

  PMID: 35598015 BACKGROUND

• Hennessy M, Heary C, Laws R, van Rhoon L, Toomey E, Wolstenholme H, Byrne M. The effectiveness of health professional-delivered interventions during the first 1000 days to prevent overweight/obesity in children: A systematic review. Obes Rev. 2019 Dec;20(12):1691-1707. doi: 10.1111/obr.12924. Epub 2019 Sep 2.

  PMID: 31478333 BACKGROUND

• Hemmingsson E. Early Childhood Obesity Risk Factors: Socioeconomic Adversity, Family Dysfunction, Offspring Distress, and Junk Food Self-Medication. Curr Obes Rep. 2018 Jun;7(2):204-209. doi: 10.1007/s13679-018-0310-2.

  PMID: 29704182 BACKGROUND

• Haire-Joshu D, Tabak R. Preventing Obesity Across Generations: Evidence for Early Life Intervention. Annu Rev Public Health. 2016;37:253-71. doi: 10.1146/annurev-publhealth-032315-021859.

  PMID: 26989828 BACKGROUND

• Gross RS, Mendelsohn AL, Yin HS, Tomopoulos S, Gross MB, Scheinmann R, Messito MJ. Randomized controlled trial of an early child obesity prevention intervention: Impacts on infant tummy time. Obesity (Silver Spring). 2017 May;25(5):920-927. doi: 10.1002/oby.21779. Epub 2017 Mar 22.

  PMID: 28332324 BACKGROUND

• Galindo-Neto NM, Alexandre ACS, Barros LM, Sa GGM, Carvalho KM, Caetano JA. Creation and validation of an educational video for deaf people about cardiopulmonary resuscitation. Rev Lat Am Enfermagem. 2019 Mar 10;27:e3130. doi: 10.1590/1518-8345.2765.3130.

  PMID: 30916231 BACKGROUND

• Flores-Pena Y, Aguado-Barrera ME, Cerda-Flores RM, Cortes-Gutierrez EI, Davila-Rodriguez MI. [Maternal perception of her child's weight and unrelated children less than 1 year old]. Aten Primaria. 2016 Nov;48(9):579-585. doi: 10.1016/j.aprim.2015.10.003. Epub 2015 Dec 22. Spanish.

  PMID: 26718345 BACKGROUND

• Felzer-Kim IT, Erickson K, Adkins C, Hauck JL. Wakeful Prone "Tummy Time" During Infancy: How Can We Help Parents? Phys Occup Ther Pediatr. 2020;40(6):651-668. doi: 10.1080/01942638.2020.1742847. Epub 2020 Mar 19.

  PMID: 32192403 BACKGROUND

• Estrada-Gutierrez G, Zambrano E, Polo-Oteyza E, Cardona-Perez A, Vadillo-Ortega F. Intervention during the first 1000 days in Mexico. Nutr Rev. 2020 Dec 1;78(Suppl 2):80-90. doi: 10.1093/nutrit/nuaa082.

  PMID: 33196088 BACKGROUND

• Enright G, Allman-Farinelli M, Redfern J. Effectiveness of Family-Based Behavior Change Interventions on Obesity-Related Behavior Change in Children: A Realist Synthesis. Int J Environ Res Public Health. 2020 Jun 8;17(11):4099. doi: 10.3390/ijerph17114099.

  PMID: 32521815 BACKGROUND

• Eichner-Seitz N, Pate RR, Paul IM. Physical activity in infancy and early childhood: a narrative review of interventions for prevention of obesity and associated health outcomes. Front Endocrinol (Lausanne). 2023 May 24;14:1155925. doi: 10.3389/fendo.2023.1155925. eCollection 2023.

  PMID: 37293499 BACKGROUND

• Downing KL, Del Pozo Cruz B, Sanders T, Zheng M, Hnatiuk JA, Salmon J, Hesketh KD. Outdoor time, screen time and sleep reported across early childhood: concurrent trajectories and maternal predictors. Int J Behav Nutr Phys Act. 2022 Dec 29;19(1):160. doi: 10.1186/s12966-022-01386-x.

  PMID: 36581865 BACKGROUND

• de Vries AG, Huiting HG, van den Heuvel ER, L'Abee C, Corpeleijn E, Stolk RP. An activity stimulation programme during a child's first year reduces some indicators of adiposity at the age of two-and-a-half. Acta Paediatr. 2015 Apr;104(4):414-21. doi: 10.1111/apa.12880. Epub 2015 Jan 7.

  PMID: 25425024 BACKGROUND

• Dattilo AM, Saavedra JM. Nutrition Education: Application of Theory and Strategies during the First 1,000 Days for Healthy Growth. Nestle Nutr Inst Workshop Ser. 2019;92:1-18. doi: 10.1159/000499544. Epub 2019 Nov 28.

  PMID: 31779004 BACKGROUND

• Wang Y, Min J, Khuri J, Li M. A Systematic Examination of the Association between Parental and Child Obesity across Countries. Adv Nutr. 2017 May 15;8(3):436-448. doi: 10.3945/an.116.013235. Print 2017 May.

  PMID: 28507009 BACKGROUND

• Crncec R, Barnett B, Matthey S. Development of an instrument to assess perceived self-efficacy in the parents of infants. Res Nurs Health. 2008 Oct;31(5):442-53. doi: 10.1002/nur.20271.

  PMID: 18297638 BACKGROUND

• Carson V, Zhang Z, Predy M, Pritchard L, Hesketh KD. Longitudinal associations between infant movement behaviours and development. Int J Behav Nutr Phys Act. 2022 Jan 28;19(1):10. doi: 10.1186/s12966-022-01248-6.

  PMID: 35090492 BACKGROUND

• Carson V, Lee EY, Hewitt L, Jennings C, Hunter S, Kuzik N, Stearns JA, Unrau SP, Poitras VJ, Gray C, Adamo KB, Janssen I, Okely AD, Spence JC, Timmons BW, Sampson M, Tremblay MS. Systematic review of the relationships between physical activity and health indicators in the early years (0-4 years). BMC Public Health. 2017 Nov 20;17(Suppl 5):854. doi: 10.1186/s12889-017-4860-0.

  PMID: 29219090 BACKGROUND

• Cardenas-Villarreal VM, Hernandez-Barrera L, Castro-Sifuentes D, Guevara-Valtier MC, Trejo-Valdivia B. Trends in overweight and obesity in children under 24 months of age in Mexico (2012-2020): analysis of four national health surveys. Cad Saude Publica. 2023 Dec 22;39(12):e00046123. doi: 10.1590/0102-311XEN046123. eCollection 2023.

  PMID: 38126557 BACKGROUND

• Mendres-Smith AE, Borrero JC, Castillo MI, Davis BJ, Becraft JL, Hussey-Gardner B. Tummy time without the tears: The impact of parent positioning and play. J Appl Behav Anal. 2020 Sep;53(4):2090-2107. doi: 10.1002/jaba.715. Epub 2020 May 20.

  PMID: 32436294 BACKGROUND

• Bohman B, Nyberg G, Sundblom E, Elinder LS. Validity and Reliability of a Parental Self-Efficacy Instrument in the Healthy School Start Prevention Trial of Childhood Obesity. Health Educ Behav. 2014 Aug;41(4):392-6. doi: 10.1177/1090198113515243. Epub 2013 Dec 25.

  PMID: 24369178 BACKGROUND

• Black MM, Hager ER, Wang Y, Hurley KM, Latta LW, Candelaria M, Caulfield LE. Toddler obesity prevention: A two-generation randomized attention-controlled trial. Matern Child Nutr. 2021 Jan;17(1):e13075. doi: 10.1111/mcn.13075. Epub 2020 Sep 4.

  PMID: 32885909 BACKGROUND

• Ardic C, Usta O, Omar E, Yildiz C, Memis E. Effects of infant feeding practices and maternal characteristics on early childhood obesity. Arch Argent Pediatr. 2019 Feb 1;117(1):26-33. doi: 10.5546/aap.2019.eng.26. English, Spanish.

  PMID: 30652443 BACKGROUND

• Alves JGB, Alves GV. Effects of physical activity on children's growth. J Pediatr (Rio J). 2019 Mar-Apr;95 Suppl 1:72-78. doi: 10.1016/j.jped.2018.11.003. Epub 2018 Dec 26.

  PMID: 30593790 BACKGROUND

• Alhwoaimel NA, Almarzoug H, Aldukhaini R, Altamimi R, Aldosre M, Al-Faris S, Azab AR. Parental knowledge of children's motor development: A cross-sectional study in Saudi Arabia. Res Dev Disabil. 2023 Aug;139:104552. doi: 10.1016/j.ridd.2023.104552. Epub 2023 Jun 7.

  PMID: 37295126 BACKGROUND

Related Links

• Mexican Association of Market Intelligence and Opinion Agencies
• UNICEF Program Guide: Prevention of Overweight and Obesity in Children and Adolescents.
• Establishment of priority areas of action for the prevention of Childhood Obesity.
• Obesity and overweight.
• WHO Child Growth Patterns: Training Course on Child Growth Assessment
• Regulation of the General Health Law on Health Research. DOF 02-04-2014

MeSH Terms

Conditions

Obesity; Health Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Velia M Cárdenas Villarreal, PhD

  Universidad Autonoma de Nuevo León

  STUDY DIRECTOR

• Jorge A Mayo Abarca, Master

  Universidad Autonoma de Nuevo León

  STUDY CHAIR

• Gloria Carvajal Carrascal, PhD

  Universidad de la Sabana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Nursing

Model Details: 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).

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: September 2, 2024
• Primary Completion: December 14, 2024
• Study Completion: August 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)