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

NCT06617299 | Completed

• 1 other identifier: FAEN-D-2017
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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: \"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).

Conditions

Prevention Childhood Obesity

Keywords

Infants; Responsive Feeding

Outcome Measures

Primary Outcomes (2)

• Change the practice of responsive feeding in mothers with infants under 6 months of age.

  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.

• Healthy weight maintenance in infants

  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.

Secondary Outcomes (5)

• Mother's Knowledge on the development and feeding practices of the child

  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

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

• Infant temperament

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

• Parental Self-Efficacy

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

• Feeding Self-Efficacy

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

Study Arms (2)

Responsive Feeding Group

EXPERIMENTAL

Group to receive information on responsive feeding

Behavioral: Intervention Identifies and Responds

Breastfeeding Group

NO INTERVENTION

Group to receive information disseminated by hospital staff on breastfeeding

Interventions

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).

Responsive Feeding 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 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.

You may not qualify if:

• Hospital stay of the mother/child dyad for more than 7 days after birth.
• 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).

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (39)

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  BACKGROUND

Related Links

• Ley General de Salud

Study Officials

• Velia M Cárdenas Villareal, PhD

  Universidad Autónoma de Nuevo León - Facultad de Enfermería

  STUDY DIRECTOR

• Gabriela I Martínez Figueroa, Master

  Universidad Autónoma de Nuevo León - Facultad de Enfermería

  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 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).

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: September 10, 2024
• Primary Completion: January 6, 2025
• Study Completion: February 25, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)