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| Name | Class |
|---|---|
| Universidad de la Sabana | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tummy Time Group | Experimental | This group will receive the 12-week intervention, which will have follow-up measurements during the implementation of the intervention. |
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| Hospital Group | No Intervention | This group receives the usual hospital care where the mother is provided with general information on breastfeeding, vaccination and infant screening. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tummy Time for the prevention of childhood obesity | Behavioral | A cognitive-behavioral intervention aimed at mothers of infants is presented that aims to increase the practice of TT and maintain a healthy weight in the infant, called "Tummy Time for the prevention of childhood obesity", within the intervention modifiable variables are involved that directly impact the expected results such as: the knowledge and beliefs of the mothers, infant temperament, parental self-efficacy and self-efficacy for the practice of TT. The intervention lasts 12 weeks from the first contact with the participants and consists of eight sessions broken down as follows: the first session is presented in a face-to-face format with expository, audiovisual and demonstrative means; sessions two, four, five and seven are provided through a text message with use WhatsApp® and the use of visual media. Sessions three, six and eight are delivered via telephone call with the aim of offering feedback on the doubts generated up to that point. |
| Measure | Description | Time Frame |
|---|---|---|
| Increased practice of tummy time in infants | 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. | It will be measured at baseline, 3 and 6 months. |
| Maintenance of healthy weight in 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). | It will be measured at baseline, at 3 and 6 months of age of the infant. |
| Measure | Description | Time Frame |
|---|---|---|
| increasing mothers' knowledge of developmental milestones | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Velia M Cárdenas Villarreal, PhD | Universidad Autonoma de Nuevo León | Study Director |
| Jorge A Mayo Abarca, Master | Universidad Autonoma de Nuevo León | Study Chair |
| Gloria Carvajal Carrascal, PhD | Universidad de la Sabana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Dr. Jose Eleuterio Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22182309 | Background | Taylor BJ, Heath AL, Galland BC, Gray AR, Lawrence JA, Sayers RM, Dale K, Coppell KJ, Taylor RW. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth. BMC Public Health. 2011 Dec 19;11:942. doi: 10.1186/1471-2458-11-942. | |
| 31833836 |
| Label | URL |
|---|---|
| Mexican Association of Market Intelligence and Opinion Agencies | View source |
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Not due to the protection of participant confidentiality given by informed consent. Statistical data only.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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The present research will be a phase II intervention study (Gitlin & Czaja, 2016), of the Pilot Randomized Clinical Trial (RCT) type, because it is intended to manipulate the independent variable that will be the intervention that integrates the components of: knowledge, beliefs, infant temperament, self-efficacy and sedentary practices, to measure the effect on the variables dependent on Tummy Time practice practice and healthy weight control. The Experimental Group (EG) and Control Group (CG) will be randomized, the intervention will be with a single-blind approach and repeated measurements (Grove & Burns, 2015).
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| It will be measured at baseline, at 3 and 6 months |
| Increased knowledge of tummy time | 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. | Measured at baseline, 3 months and 6 months |
| Positive and negative beliefs about tummy time | 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 | Measured at baseline, 3 months and 6 months |
| increased implementation of tummy time | 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. | Measured at baseline, 3 months and 6 months |
| Maternal Perception of Child's Weight | 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. | will be measured at baseline, 3 months and 6 months |
| Child Behavior | 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. | will be measured at baseline, 3 months and 6 months |
| increased mother's self-confidence in child rearing | 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). | will be measured at baseline, 3 months and 6 months |
| Perceived Parental Self-Efficacy for Physical Activity Behaviors | 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. | will be measured at baseline, 3 months and 6 months |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |