Cognitive-behavioral Intervention to Increase the Practice of Responsive Feeding and Maintain Healthy Weight in Infants

Launched by UNIVERSIDAD AUTONOMA DE NUEVO LEON · Sep 24, 2024

Nctid: NCT06617299

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000063766", "term"=>"Pediatric Obesity"}], "ancestors"=>[{"id"=>"D000009765", "term"=>"Obesity"}, {"id"=>"D000050177", "term"=>"Overweight"}, {"id"=>"D000044343", "term"=>"Overnutrition"}, {"id"=>"D000009748", "term"=>"Nutrition Disorders"}, {"id"=>"D000001835", "term"=>"Body Weight"}], "browseLeaves"=>[{"id"=>"M12701", "name"=>"Obesity", "relevance"=>"LOW"}, {"id"=>"M5114", "name"=>"Body Weight", "relevance"=>"LOW"}, {"id"=>"M30155", "name"=>"Pediatric Obesity", "asFound"=>"Childhood Obesity", "relevance"=>"HIGH"}, {"id"=>"M26186", "name"=>"Overweight", "relevance"=>"LOW"}, {"id"=>"M25307", "name"=>"Overnutrition", "relevance"=>"LOW"}, {"id"=>"M12684", "name"=>"Nutrition Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"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 \\& Gray, 2015)."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>144}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-09-10", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Increase 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.", "description"=>"To measure the practice of Responsive Feeding in the mother/child dyad, the Feeding Practices and Structure Questionnaire (FPSQ) will be used, a questionnaire in original English designed by Jansen et al., (2022), replicated in the Mexican context (Pérez, 2023). It aims to measure the responsiveness of parents in children under 6 months, mainly breastfed or bottle-fed throughout childhood. It is made up of 18 items divided into 4 dimensions: 1) on-demand feeding, which refers to the fact that the parents make the decision about when the child should be fed; 2) use of food to calm conceptualized as the fact that parents use food to calm or control emotions; 3) persuasive feeding is the fact that parents encourage (pressure) the child to eat more, even when they show signs of satiety; and 4) parent-directed feeding referring to the fact that the parents make the decision (or have a rule) about how long / how much the child feeds."}, {"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.", "description"=>"The nutritional status of the infant will be analyzed through the indicators of weight/length and BMI/age during birth and follow-up measurements, this according to the WHO and the open-access computer program Anthro®, the patterns of child growth in children under two years of age classified by the z-scores will be used : malnutrition (≤ -2 SD); normal (≥ -1 and ≤ 1 SD); SP (\\> 1 and ≤ 2 DE) and OB (≥ 2 DE)."}], "secondaryOutcomes"=>[{"measure"=>"Mother'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.", "description"=>"To measure the knowledge variable about Responsive Feeding, it will be measured with the Infant Hunger and Satiety Signals Knowledge Scale, originally a scale used in the United States, it was adapted by Ortiz et al. (2020) to the Mexican context, it aims to measure the mother\\'s knowledge regarding the hunger and satiety signals emitted by the infant under 6 months of age. It is structured by 2 questions: 1) Do you know that your child is hungry? with 10 signs to identify them; 2) Do you know that your child is full or full? followed by 8 satiety signals to identify them."}, {"measure"=>"Maternal attitudes Mother'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.", "description"=>"To measure attitudes towards feeding, the Iowa Infant Feeding Attitude Scale (De la Mora et al., 1999) adapted to the Mexican context by Aguilar-Navarro et al. (2016) will be used, it is a one-dimensional scale made up of 17 items that measure the attitude of mothers towards infant feeding (breastfeeding and/or formula feeding). The way to respond is through a five-point Likert-type scale, where 1) totally disagree; 2) disagree; 3) neither disagree nor agree; 4) agree; 5) Totally agree. It is interpreted that the lower the score, the breastfeeding method is favored and the higher the score, the better attitudes towards formula feeding."}, {"measure"=>"Infant temperament", "timeFrame"=>"Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.", "description"=>"To measure infant temperament, the Infant Behavior Questionnaire (IBQ-R) (Putnam, 2014) will be used, adapted to the Mexican context by Ortega et al. (2012), its main objective is to measure infant temperament during the last week prior to its application. It is structured by 37 items divided into three dimensions: 1) extroversion; 2) negative affectivity; and 3) self-regulation.\n\nIt has a 7-point Likert-type response scale ranging from 1 = never to 7 = always, for interpretation item 11 evaluates inversely, a sum of the total of the items is made and it is considered that, the higher the score, the greater the characteristic of child temperament according to the three dimensions of the questionnaire."}, {"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.", "description"=>"To measure parental self-efficacy , the Karitane Parental Trust Scale (KPCS) proposed by Crncec et al. (2008) will be used, which aims to measure parental self-efficacy in parents of infants aged 0 to 12 months. It is made up of 15 items divided into three dimensions: 1) perceptions of parenting capacity (5, 4, 6, 2, 8, 7, 3 and 11); 2) available parenting support (15, 13, 9, 14, and 12) and 3) perceptions of child development (10 and 1).\n\nThe structure to answer each of the questions is through a Likert-type scale, where 4 possible options are presented: 0=No, almost never, 1= No, not very often, 2= Yes, sometimes, 3= Yes, most of the time. Despite having dimensions, the authors recommend that its evaluation be done in a one-dimensional way. So if the scores range from 0 to 3, higher scores indicate greater parental self-efficacy, therefore, the range of possible scores on the KPCS is from 0 to 45."}, {"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.", "description"=>"To measure food self-efficacy , the Food Self-Efficacy Scale proposed by Chen et al. (2022) will be used, which aims to measure maternal self-confidence in their ability to meet feeding demands and successfully perform feeding behavior. It is made up of 5 items in a single dimension.\n\nThe structure to answer each of the questions is through a Likert-type scale, where 4 possible options are presented: 1=Strongly disagree, 2= Disagree, 3= Agree, 4= Strongly agree. Scores range from 1 to 4, higher scores indicate greater food self-efficacy, therefore the range of possible scores on this scale is 4 to 20"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Infants", "Responsive Feeding"], "conditions"=>["Prevention Childhood Obesity"]}, "referencesModule"=>{"references"=>[{"pmid"=>"31188021", "type"=>"BACKGROUND", "citation"=>"Whitfield KC, Ventura AK. 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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."}, {"type"=>"BACKGROUND", "citation"=>"Aguilar-Navarro, H. J., Coronado-Castilleja, A., Gómez-Hernández, O. J., & Cobos-Aguilar, H. (2016). Adaptation of the Iowa Infant Feeding Attitude Scale in the Mexican population. Acta pediátrica de México, 37(3), 149-158."}], "seeAlsoLinks"=>[{"url"=>"https://www.diputados.gob.mx/LeyesBiblio/regley/Reg_LGS_MIS.pdf", "label"=>"Ley General de Salud"}]}, "descriptionModule"=>{"briefSummary"=>"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: \\"Identify and Respond\\" 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)."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria: Mother/child dyad, apparently healthy, with a minimum of 12 hours postpartum and/or cesarean section, of the mother who knows how to read and write, who has a smartphone, access to the internet and agrees to participate in the study.\n\n-\n\nExclusion Criteria: Hospital stay of the mother/child dyad more than 7 days after birth. Of the child: under 37 SDG, a congenital anomaly or a physical disability that could affect feeding (cleft palate, cleft lip) and low birth weight (\\< 2,500 kg).\n\n-"}, "identificationModule"=>{"nctId"=>"NCT06617299", "briefTitle"=>"Cognitive-behavioral Intervention to Increase the Practice of Responsive Feeding and Maintain Healthy Weight in Infants", "organization"=>{"class"=>"OTHER", "fullName"=>"Universidad Autonoma de Nuevo Leon"}, "officialTitle"=>"Cognitive-Behavioral Intervention Targeting Mothers to Increase Practice of Responsive Feeding and Maintain Healthy Weight in Infants Minors", "orgStudyIdInfo"=>{"id"=>"FAEN-D-2017"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Responsive Feeding Group", "description"=>"Group to receive information on responsive feeding", "interventionNames"=>["Behavioral: Intervention Identifies and Responds"]}, {"type"=>"NO_INTERVENTION", "label"=>"Breastfeeding Group", "description"=>"Group to receive information disseminated by hospital staff on breastfeeding"}], "interventions"=>[{"name"=>"Intervention Identifies and Responds", "type"=>"BEHAVIORAL", "description"=>"The treatment of Experimental Group is described, which is made up of eight individual sessions taught over three months. Session one will be in face-to-face format, the content, resources and activities are described in tables 2 and 3. The remaining seven sessions will be follow-up sessions (four sessions by message (WhatsApp®) where motivational messages and reinforcement information will be sent; and 3 sessions by phone call for feedback, see details of time, content, activities and resources in tables 2 and 3.\n\nThe design of the intervention is aimed at increasing the practice of Responsive Feeding in mothers with children under 6 months of age, is based on the methodology of Sidani and Braden (2021); on CHW (Bandura, 1986); and behavior change techniques to help people have healthy eating habits (Michie et al., 2011).", "armGroupLabels"=>["Responsive Feeding Group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"64460", "city"=>"Monterrey", "state"=>"Nuevo León", "status"=>"RECRUITING", "country"=>"Mexico", "contacts"=>[{"name"=>"Hospital Universitario Dr. José Eleuterio González Hospital Publico", "role"=>"CONTACT", "email"=>"subdireccion.investigacion@uanl.edu.mx", "phone"=>"81 8389 1111"}], "facility"=>"Hospital Universitario Dr. José Eleuterio González", "geoPoint"=>{"lat"=>25.67507, "lon"=>-100.31847}}], "centralContacts"=>[{"name"=>"Jorge A Mayo Abarca, Master", "role"=>"CONTACT", "email"=>"jorge.mayoa@uanl.edu.mx", "phone"=>"52 747 529 0347"}, {"name"=>"Gabriela I Martínez Figueroa, Master", "role"=>"CONTACT", "email"=>"gabriela.martinezf@uanl.edu.mx", "phone"=>"52 747 133 8212"}], "overallOfficials"=>[{"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 Autónoma de Nuevo León - Facultad de Enfermería"}, {"name"=>"Gloria Carvajal Carrascal, PhD", "role"=>"STUDY_CHAIR", "affiliation"=>"Universidad de la Sabana"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Personal data will not be shared with other researchers for the protection of personal data included in the study ethics. Only general data derived from the research results will be shared."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Universidad Autonoma de Nuevo Leon", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Universidad de la Sabana", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Master in Nursing", "investigatorFullName"=>"Jorge Alberto Mayo Abarca", "investigatorAffiliation"=>"Universidad Autonoma de Nuevo Leon"}}}}