Cognitive-Behavioral Intervention to Increase Tummy Time Practice and Maintain Healthy Weight in Infants
- Conditions
- Obesity/therapyPrevention and Control
- Interventions
- Behavioral: Tummy Time for the prevention of childhood obesity
- Registration Number
- NCT06616467
- Lead Sponsor
- Universidad Autonoma de Nuevo Leon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 144
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tummy Time Group Tummy Time for the prevention of childhood obesity This group will receive the 12-week intervention, which will have follow-up measurements during the implementation of the intervention.
- Primary Outcome Measures
Name Time Method Increased practice of tummy time in infants 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 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).
- Secondary Outcome Measures
Name Time Method increasing mothers' knowledge of developmental milestones It will be measured at baseline, at 3 and 6 months The questionnaire \"parents\' knowledge of developmental milestones in children\", developed and validated by Rickhy et al. (2010) in English, will be used, which aims to assess parents\' knowledge about the time in which their children should achieve different skills. It consists of 17 questions distributed in five dimensions: 1) physical development (1, 2, 3 and 4); 2) cognitive development (5, 6 and 7); 3) social development (8, 9, 10, 11 and 12) and 4) and emotional development (13, 14, 15, 16 and 17), with a dichotomous response scale of 1= true, 2= false. For interpretation, the answers are graded at 1 = correct and 0 = incorrect, the score ranges from 0 to 17 points, it being understood that the higher the score, the higher the level of knowledge the parents have.
Increased knowledge of tummy time Measured at baseline, 3 months and 6 months The questionnaire \"knowledge, beliefs and implementation on the prone position\" This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, the first dimension measures knowledge about TT, it is made up of nine questions that are answered on a dichotomous scale of 1= true; 2= false, presented a Cronbach\'s alpha reliability of .67. For their interpretation, the questions are evaluated and transformed into 1= correct; 0= incorrect, the score ranges from 0 to 9 points, where it is interpreted that the higher the score, the higher the level of knowledge about TT the parents have.
Positive and negative beliefs about tummy time Measured at baseline, 3 months and 6 months The questionnaire knowledge, beliefs and implementation on the prone position. This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, The second dimension assesses parents\' beliefs about TT is made up of 18 items with a five-point Likert-type response scale (1=strongly disagree, 2=disagree, 3=neither disagree nor agree, 4=agree and 5=strongly agree), is subdivided into positive beliefs (10, 11, 12, 13, 14, 15, 16, 17, and 18) and negative beliefs (1, 2, 3, 4, 5, 6, 7, 8, and 9), the questionnaire as a whole presented a Cronbach\'s alpha reliability of .45 in the original language; The total score ranges from 18 to 90 points, it is interpreted that the higher the score, the higher the level of positive and/or negative beliefs
increased implementation of tummy time Measured at baseline, 3 months and 6 months The questionnaire knowledge, beliefs and implementation on the prone position. This indicator was developed and validated by Ricard and Metz (2014) in English, It consists of three dimensions, dimension three evaluates the factors, frequency and duration of TT in the infant, it is made up of 11 items with a multiple response scale for each item, the interpretation is descriptive per item.
Maternal Perception of Child's Weight will be measured at baseline, 3 months and 6 months It is made up of an item of: \"I think my child is\" with a multiple choice of: underweight, a little underweight, more or less with the correct weight, with a little SP and with SP, it is also evaluated with a panel of five images according to the sex of the child, in which the mother must select two things: 1) the image that best represents the weight of her child and 2) the image that represents a healthy child. The selection of the answers will determine the mother\'s perception of her child\'s weight and a healthy weight.
Child Behavior will be measured at baseline, 3 months and 6 months the questionnaire aims to measure infant temperament as a sign of the frequency in which the infant presents the behavior during a week prior to application. It is composed of 37 items with a 7-point Likert-type response scale ranging from 1= never to 7= always, and is divided into three dimensions. For the interpretation, item 11 evaluates inversely, a sum of the total of the items is made, where the total score ranges from 37 to 259 points, it is considered that, the higher the score, the greater the characteristic of infant temperament as a function of the three dimensions.
Likewise, a subscale of \"calming techniques\" is presented, which aims to determine which techniques the mother has used to calm her child in the last two weeks, it is composed of 11 items with a 7-point Likert-type response scale ranging from 1= none to 7= always. The interpretation is carried out in a descriptive way of each item.increased mother's self-confidence in child rearing will be measured at baseline, 3 months and 6 months the \"Karitane Parental Confidence Scale\". It is composed of three dimensions of: 1) perceptions of parenting capacity; 2) available parenting support and 3) perceptions of child development. It is made up of a total of 15 items with a four-point Likert-type response scale of: 0 = No, almost never, 1 = No, not very often, 2 = Yes, sometimes, 3 = Yes, most of the time, with a range of scores from 0 to 45 maximum. The interpretation is made with the total sum of the items, where the higher the score, the higher the level of self-efficacy perceived by the parents for upbringing, in addition cohorts are presented according to the score where they have: severe clinical range (31 or less); moderate clinical range (31-35); mild clinical range (36-39) and no clinical range (40 or more).
Perceived Parental Self-Efficacy for Physical Activity Behaviors will be measured at baseline, 3 months and 6 months the questionnaire \"perceived parental self-efficacy on dietary and physical activity behavior\", developed and validated by Bohman et al. (2013) in its English version. It is made up of 14 items that are subdivided into two dimensions: 1) self-efficacy for dietary behaviors (1, 2, 3, 4, 5, 6 and 7) and 2) self-efficacy for physical activity behaviors (8, 9, 10, 11, 12, 13 and 14), an 11-point Likert-type response scale ranging from 0= nothing to 10= to a very high degree, with a score ranging from 0 to 140, it is interpreted that, the higher the score, the greater the parents\' perception of self-efficacy. It has presented reliability through Cronbach\'s alpha coefficient of .88.
Trial Locations
- Locations (1)
Hospital Universitario Dr. Jose Eleuterio Gonzalez
🇲🇽Monterrey, Nuevo León, Mexico