Clinical trial NCT06617299: Cognitive-behavioral Intervention to Increase the Practice of Responsive Feeding and Maintain Healthy Weight in Infants
Official title: Cognitive-Behavioral Intervention Targeting Mothers to Increase Practice of Responsive Feeding and Maintain Healthy Weight in Infants Minors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention Childhood Obesity
Keywords: Infants
Responsive Feeding
Lead sponsor: Universidad Autonoma de Nuevo Leon
Sponsor class: OTHER
Collaborators: name: Universidad de la Sabana
First posted: 2024-09-27
Enrollment: 136
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will be a phase II intervention study of the pilot clinical trial type because the preliminary effect of an intervention will be evaluated where the Experimental Group (EG) will receive the intervention aimed at increasing the practice of RP and maintaining a healthy weight. The Control Group (CG) will receive the usual care, there will be randomization to both groups through a list with the number of rooms, the pilot clinical trial will be of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later) (Grove, Burns \&amp; Gray, 2015).
Primary purpose: PREVENTION

Brief summary: Introduction: Childhood overweight and obesity in Mexico is a serious public health problem. Perceptive eating is a factor in the prevention of obesity and occurs when the caregiver recognizes the signs of hunger and satiety, responds in a timely manner to these needs. However, its implementation is often a challenge for parents. Studies show that there is low knowledge and self-efficacy, as well as erroneous beliefs about food. Teaching perceptive eating can lead to: the development of healthy eating habits, generate warm environments in which the interaction between parents and children is strengthened and promote self-regulation of hunger and satiety sensations and prevent overweight and obesity. Interventions on Responsive Feeding for the prevention of healthy weight in infants under six months of age are null in Mexico. Objective: To evaluate the effect of the intervention: \&#34;Identify and Respond\&#34; aimed at Mexican mothers to increase the practice of Responsive Feeding and maintain a healthy weight in children under 6 months of age. Methodology: The present study will be a pilot clinical trial type intervention study because the preliminary effect will be evaluated where the Experimental Group will receive the intervention aimed at increasing the practice of Responsive Feeding , there will be randomization of repeated measurements by virtue of which measurements will be made at three times: before the intervention (baseline) and follow-up (post-test 3 and 6 months later). The sample consisted of 72 mothers with children younger than 6 months for each group (N=144).


Eligibility criteria: Inclusion Criteria:

* Mother/child dyad, apparently healthy.
* Minimum of 12 hours postpartum and/or cesarean section.
* Mother who knows how to read and write.
* Mother who has a smartphone.
* Mother with internet access.
* Mother who agrees to participate in the study.

Exclusion Criteria:

* Hospital stay of the mother/child dyad for more than 7 days after birth.
* Child-related exclusions:
* Gestational age under 37 weeks (SDG).
* Presence of a congenital anomaly.
* Physical disability that could affect feeding (e.g., cleft palate, cleft lip).
* Low birth weight (\< 2,500 g).

Primary outcomes:
measure: Change the practice of responsive feeding in mothers with infants under 6 months of age.
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
measure: Healthy weight maintenance in infants
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Secondary outcomes:
measure: Mother&#39;s Knowledge on the development and feeding practices of the child
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
measure: Maternal attitudes Mother&#39;s disposition towards infant feeding methods
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
measure: Infant temperament
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
measure: Parental Self-Efficacy
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
measure: Feeding Self-Efficacy
timeFrame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José Eleuterio González
state: Nuevo León
Study officials:
affiliation: Universidad Autónoma de Nuevo León - Facultad de Enfermería
name: Velia M Cárdenas Villareal, PhD
role: STUDY_DIRECTOR
affiliation: Universidad Autónoma de Nuevo León - Facultad de Enfermería
name: Gabriela I Martínez Figueroa, Master
role: STUDY_CHAIR
affiliation: Universidad de la Sabana
name: Gloria Carvajal Carrascal, PhD
role: STUDY_CHAIR
References:
citation: Whitfield KC, Ventura AK. Exploration of Responsive Feeding During Breastfeeding Versus Bottle Feeding of Human Milk: A Within-Subject Pilot Study. Breastfeed Med. 2019 Sep;14(7):482-486. doi: 10.1089/bfm.2019.0069. Epub 2019 Jun 12.
citation: Wen LM, Baur LA, Rissel C, Wardle K, Alperstein G, Simpson JM. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial). BMC Public Health. 2007 May 10;7:76. doi: 10.1186/1471-2458-7-76.
citation: Vilar-Compte M, Perez-Escamilla R, Orta-Aleman D, Cruz-Villalba V, Segura-Perez S, Nyhan K, Richter LM. Impact of baby behaviour on caregiver's infant feeding decisions during the first 6 months of life: A systematic review. Matern Child Nutr. 2022 May;18 Suppl 3(Suppl 3):e13345. doi: 10.1111/mcn.13345. Epub 2022 Apr 1.
citation: Savage JS, Hohman EE, Marini ME, Shelly A, Paul IM, Birch LL. INSIGHT responsive parenting intervention and infant feeding practices: randomized clinical trial. Int J Behav Nutr Phys Act. 2018 Jul 9;15(1):64. doi: 10.1186/s12966-018-0700-6.
citation: Savage JS, Birch LL, Marini M, Anzman-Frasca S, Paul IM. Effect of the INSIGHT Responsive Parenting Intervention on Rapid Infant Weight Gain and Overweight Status at Age 1 Year: A Randomized Clinical Trial. JAMA Pediatr. 2016 Aug 1;170(8):742-9. doi: 10.1001/jamapediatrics.2016.0445.
citation: Ruggiero CF, Hohman EE, Birch LL, Paul IM, Savage JS. INSIGHT responsive parenting intervention effects on child appetite and maternal feeding practices through age 3 years. Appetite. 2021 Apr 1;159:105060. doi: 10.1016/j.appet.2020.105060. Epub 2020 Dec 1.
citation: Rossiter MD, Richard B, Whitfield KC, Mann L, McIsaac JD. Responsive feeding values and practices among families across the Canadian Maritime provinces. Appl Physiol Nutr Metab. 2022 May;47(5):495-501. doi: 10.1139/apnm-2021-0692. Epub 2022 Feb 3.
citation: Redsell SA, Slater V, Rose J, Olander EK, Matvienko-Sikar K. Barriers and enablers to caregivers' responsive feeding behaviour: A systematic review to inform childhood obesity prevention. Obes Rev. 2021 Jul;22(7):e13228. doi: 10.1111/obr.13228. Epub 2021 Mar 29.
citation: Quah PL, Chan YH, Aris IM, Pang WW, Toh JY, Tint MT, Broekman BF, Saw SM, Kwek K, Godfrey KM, Gluckman PD, Chong YS, Meaney MJ, Yap FK, van Dam RM, Lee YS, Chong MF; GUSTO Study Group. Prospective associations of appetitive traits at 3 and 12 months of age with body mass index and weight gain in the first 2 years of life. BMC Pediatr. 2015 Oct 12;15:153. doi: 10.1186/s12887-015-0467-8.
citation: 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.
citation: Perez-Escamilla R, Segura-Perez S, Hall Moran V. Dietary guidelines for children under 2 years of age in the context of nurturing care. Matern Child Nutr. 2019 Jul;15(3):e12855. doi: 10.1111/mcn.12855.
citation: Paul IM, Williams JS, Anzman-Frasca S, Beiler JS, Makova KD, Marini ME, Hess LB, Rzucidlo SE, Verdiglione N, Mindell JA, Birch LL. The Intervention Nurses Start Infants Growing on Healthy Trajectories (INSIGHT) study. BMC Pediatr. 2014 Jul 18;14:184. doi: 10.1186/1471-2431-14-184.
citation: Paul IM, Savage JS, Anzman SL, Beiler JS, Marini ME, Stokes JL, Birch LL. Preventing obesity during infancy: a pilot study. Obesity (Silver Spring). 2011 Feb;19(2):353-61. doi: 10.1038/oby.2010.182. Epub 2010 Aug 19.
citation: Pallewaththa P, Agampodi SB, Agampodi TC, Siribaddana SH. Knowledge, Attitudes, and Practices of Responsive Feeding in Rural Sri Lanka (A Qualitative Study). Ceylon Med J. 2019 Jun 30;64(2):70-75. doi: 10.4038/cmj.v64i2.8894.
citation: Paca-Palao A, Huayanay-Espinoza CA, Parra DC, Velasquez-Melendez G, Miranda JJ. [Association between exclusive breastfeeding and obesity in children: a cross-sectional study of three Latin American countries]. Gac Sanit. 2021 Mar-Apr;35(2):168-176. doi: 10.1016/j.gaceta.2019.09.002. Epub 2019 Nov 29. Spanish.
citation: Moura IH, Silva AFRD, Rocha ADESH, Lima LHO, Moreira TMM, Silva ARVD. Construction and validation of educational materials for the prevention of metabolic syndrome in adolescents. Rev Lat Am Enfermagem. 2017 Oct 5;25:e2934. doi: 10.1590/1518-8345.2024.2934.
citation: 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.
citation: 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.
citation: McNally J, Hugh-Jones S, Hetherington MM. "An invisible map" - maternal perceptions of hunger, satiation and 'enough' in the context of baby led and traditional complementary feeding practices. Appetite. 2020 May 1;148:104608. doi: 10.1016/j.appet.2020.104608. Epub 2020 Jan 11.
citation: Liu Y, Kong Y, Li Z, Zhang G, Wang L, Yu G. Relationships between parental responsive feeding and infant appetitive traits: The moderating role of infant temperament. Front Psychol. 2023 Feb 6;14:1115274. doi: 10.3389/fpsyg.2023.1115274. eCollection 2023.
citation: Lavner JA, Stansfield BK, Beach SRH, Brody GH, Birch LL. Sleep SAAF: a responsive parenting intervention to prevent excessive weight gain and obesity among African American infants. BMC Pediatr. 2019 Jul 5;19(1):224. doi: 10.1186/s12887-019-1583-7.
citation: Kim-Herrera EY, Ramirez-Silva I, Rodriguez-Oliveros G, Ortiz-Panozo E, Sanchez-Estrada M, Rivera-Pasquel M, Perez-Escamilla R, Rivera-Dommarco JA. Parental Feeding Styles and Their Association With Complementary Feeding Practices and Growth in Mexican Children. Front Pediatr. 2021 Dec 21;9:786397. doi: 10.3389/fped.2021.786397. eCollection 2021.
citation: Jansen E, Russell CG, Appleton J, Byrne R, Daniels LA, Fowler C, Rossiter C, Mallan KM. The Feeding Practices and Structure Questionnaire: development and validation of age appropriate versions for infants and toddlers. Int J Behav Nutr Phys Act. 2021 Jan 19;18(1):13. doi: 10.1186/s12966-021-01079-x.
citation: Hernandez E, Lavner JA, Moore AM, Stansfield BK, Beach SRH, Smith JJ, Savage JS. Sleep SAAF responsive parenting intervention improves mothers' feeding practices: a randomized controlled trial among African American mother-infant dyads. Int J Behav Nutr Phys Act. 2022 Oct 1;19(1):129. doi: 10.1186/s12966-022-01366-1.
citation: 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.
citation: 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.
citation: 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.
citation: Feeley N, Cossette S, Cote J, Heon M, Stremler R, Martorella G, Purden M. The importance of piloting an RCT intervention. Can J Nurs Res. 2009 Jun;41(2):85-99.
citation: Fangupo LJ, Heath AL, Williams SM, Somerville MR, Lawrence JA, Gray AR, Taylor BJ, Mills VC, Watson EO, Galland BC, Sayers RM, Hanna MB, Taylor RW. Impact of an early-life intervention on the nutrition behaviors of 2-y-old children: a randomized controlled trial. Am J Clin Nutr. 2015 Sep;102(3):704-12. doi: 10.3945/ajcn.115.111823. Epub 2015 Jul 29.
citation: Fabrizio CS, Lam TH, Hirschmann MR, Stewart SM. A Brief Parenting Intervention to Enhance the Parent-Child Relationship in Hong Kong: Harmony@Home. J Child Fam Stud. 2013 Jul;22(5):603-613. doi: 10.1007/s10826-012-9614-0.
citation: 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.
citation: Daniels LA, Mallan KM, Nicholson JM, Thorpe K, Nambiar S, Mauch CE, Magarey A. An Early Feeding Practices Intervention for Obesity Prevention. Pediatrics. 2015 Jul;136(1):e40-9. doi: 10.1542/peds.2014-4108. Epub 2015 Jun 8.
citation: Chen TL, Chien LY. Feeding self-efficacy and feeding outcome expectancy mediate the association between maternal depressive symptoms and responsive feeding. Acta Psychol (Amst). 2022 Oct;230:103755. doi: 10.1016/j.actpsy.2022.103755. Epub 2022 Sep 28.
citation: 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.
citation: Cardenas Villarreal VM, Ortiz Felix RE, Cortes-Castell E, Miranda Felix PE, Guevara Valtier MC, Rizo-Baeza MM. [Maternal and infant characteristics associated with obesity in infants under one year of age in northern Mexico]. Nutr Hosp. 2018 Oct 5;35(5):1024-1032. doi: 10.20960/nh.1720. Spanish.
citation: Burnett AJ, Jansen E, Appleton J, Rossiter C, Fowler C, Denney-Wilson E, Russell CG. Bidirectional associations between parental feeding practices, infant appetitive traits and infant BMIz: a longitudinal cohort study. Int J Behav Nutr Phys Act. 2022 Dec 15;19(1):153. doi: 10.1186/s12966-022-01392-z.
citation: Black MM, Tofail F, Hodges EA, Bann CM, Hamadani JD, Aktar S, Lutter CK. Rethinking Responsive Feeding: Insights from Bangladesh. Nutrients. 2022 Jul 30;14(15):3156. doi: 10.3390/nu14153156.
citation: Bahorski J, Romano M, McDougal JM, Kiratzis E, Pocchio K, Paek I. Development of an Individualized Responsive Feeding Intervention-Learning Early Infant Feeding Cues: Protocol for a Nonrandomized Study. JMIR Res Protoc. 2023 Feb 28;12:e44329. doi: 10.2196/44329.
citation: Aguilar-Navarro, H. J., Coronado-Castilleja, A., Gómez-Hernández, O. J., &amp;amp;amp;amp;amp; Cobos-Aguilar, H. (2016). Adaptation of the Iowa Infant Feeding Attitude Scale in the Mexican population. Acta pediátrica de México, 37(3), 149-158.