Cognitive-Behavioral Intervention Targeting Mothers to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Increased practice of tummy time in infants
研究概览
简要总结
Childhood obesity is a serious health problem worldwide evidenced by its high prevalence, specifically for the age group called the first 1000 days of life. This condition has serious consequences on the health of infants who suffer from it, being a precursor for the development of diseases such as diabetes and hypertension. For this reason, international organizations have proposed physical activity as a priority component for the prevention of childhood obesity. The objective of this study is to evaluate the preliminary effect of an intervention based on social cognitive theory aimed at Mexican mothers with children under six months of age to increase the practice of Tummy Time and maintain the healthy weight of the infant compared to usual care. The methodology will be a pilot randomized clinical trial with randomization to the Experimental Group and Control Group, the intervention will be with a single-blind approach and repeated measurements. A non-probabilistic sampling will be used for convenience and the sample will be 144 participants who will be dyads of mothers and children who are in the immediate postpartum hospitalized in a second-level hospital in Mexico.
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
- 是
入选标准
- •Mother-child dyads that are in the postpartum
- •mothers who declare that they know how to read and write in spanish
- •have an electronic device (cell phone, tablet or computer),
- •have an internet connection.
- •Have the social network WhatsApp®
- •Agree to participate voluntarily evidenced by informed consent will be considered
排除标准
- •Women who report having received information about TT one month before the intervention.
- •Women who are actively participating in programs related to early stimulation
- •Who declare that they have a premature infant born before 37 SDG,
- •who has a low birth weight <2,500g,
- •who has a medical condition or complication at birth that impacts their physical mobility and
- •who has chronic health problems or congenital anomalies.
结局指标
主要结局
Increased practice of tummy time in infants
时间窗: It will be measured at baseline, 3 and 6 months.
The diary is made up of 15 items aimed at measuring whether the activity is applied, frequency with which it is performed, duration in each frequency and total duration of the activity within 24 hours, it is made up of open responses and must be answered according to the last week prior to the application of the instrument. The interpretation is made for each item and is compared with the recommendations given in the guidelines of international organizations (PAHO, 2019), the results are presented in a comparison to determine whether or not the recommendations given are complied with.
Maintenance of healthy weight in the infant
时间窗: It will be measured at baseline, at 3 and 6 months of age of the infant.
, the infant growth patterns in children under two years of age will be used, where the anthropometric measurements of infants during birth will be used and in the follow-up measurements self-reported by the mother, the data will be analyzed through the free access computer program Anthro ® of the WHO (2024) that allows calculating through the indicators of weight/length and BMI/age the nutritional status of the infant and be classified using the z-scores: malnutrition (≤ -2 SD); normal (≥ -1 and ≤ 1 SD); SP (\> 1 and ≤ 2 DE) and OB (≥ 2 DE).
次要结局
- increasing mothers' knowledge of developmental milestones(It will be measured at baseline, at 3 and 6 months)
- Increased knowledge of tummy time(Measured at baseline, 3 months and 6 months)
- Positive and negative beliefs about tummy time(Measured at baseline, 3 months and 6 months)
- increased implementation of tummy time(Measured at baseline, 3 months and 6 months)
- Maternal Perception of Child's Weight(will be measured at baseline, 3 months and 6 months)
- Child Behavior(will be measured at baseline, 3 months and 6 months)
- increased mother's self-confidence in child rearing(will be measured at baseline, 3 months and 6 months)
- Perceived Parental Self-Efficacy for Physical Activity Behaviors(will be measured at baseline, 3 months and 6 months)
研究者
Gabriela Iveth Martínez Figueroa
Master in Nursing
Universidad Autonoma de Nuevo Leon