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临床试验/NCT06617299
NCT06617299已完成不适用

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

Universidad Autonoma de Nuevo Leon2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
2
主要终点
Change the practice of responsive feeding in mothers with infants under 6 months of age.

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

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

时间窗: 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.

Healthy weight maintenance in infants

时间窗: 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).

次要结局

  • Mother&#39;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&#39;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.)

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Alberto Mayo Abarca

Master in Nursing

Universidad Autonoma de Nuevo Leon

研究点 (2)

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