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Completed

NCT Number: NCT06617299

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

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).

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention Identifies and Responds

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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 (&gt; 1 and ≤ 2 DE) and OB (≥ 2 DE).

Secondary outcomes

  1. Mother&#39;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&#39;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.

  2. Maternal attitudes Mother&#39;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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Collaborators

  • Universidad de la Sabana

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 27, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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