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

February 26, 2025 updated by: Jorge Alberto Mayo Abarca, Universidad Autonoma de Nuevo Leon

Cognitive-Behavioral Intervention Targeting Mothers to Increase Practice of Responsive Feeding and Maintain Healthy Weight in Infants Minors

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

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. Jose 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 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).

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: Responsive Feeding Group
Group to receive information on responsive feeding
Behavioral: Intervention Identifies and Responds

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.

The 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).
No Intervention: Breastfeeding Group
Group to receive information disseminated by hospital staff on breastfeeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy weight maintenance in infants
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
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).
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Change the practice of responsive feeding in mothers with infants under 6 months of age.
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
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.
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mother's Knowledge on the development and feeding practices of the child
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
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.
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Maternal attitudes Mother's disposition towards infant feeding methods
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
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.
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Infant temperament
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

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.

It 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.
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Parental Self-Efficacy
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

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).

The 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.
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.
Feeding Self-Efficacy
Time Frame: Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

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.

The 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
Three measurements will be taken: before the behavioral intervention, 3 months after the intervention and 6 months after the intervention.

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 Director: Velia M Cárdenas Villareal, PhD, Universidad Autónoma de Nuevo León - Facultad de Enfermería
  • Study Chair: Gabriela I Martínez Figueroa, Master, Universidad Autónoma de Nuevo León - Facultad de Enfermería
  • Study Chair: Gloria Carvajal Carrascal, PhD, Universidad de La Sabana

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 10, 2024

Primary Completion (Actual)

January 6, 2025

Study Completion (Actual)

February 25, 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 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAEN-D-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan 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.

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.

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