"El globo" and "Servicios de Salud Lomas Altas"
México, Sonora, Mexico
Location status: Recruiting
Location contact
Claudia Tovar-Palacio, Ph.D.
CONTACT
Fernanda Martinez García, M.Sc.
CONTACT
NCT Number: NCT07159971
This proposal aims to enhance the well being of schoolchildren and their families through a mobile application and multidisciplinary intervention model grounded in authoritative parenting principles and social cognitive theory.
Interested in participating?
Request Info5 year–9 year
All sexes
Interventional
Not applicable
México, Sonora, Mexico
Location status: Recruiting
Claudia Tovar-Palacio, Ph.D.
CONTACT
Fernanda Martinez García, M.Sc.
CONTACT
Childhood is recognized as a critical period of metabolic sensitivity, during which excess adiposity increases the likelihood of developing metabolic abnormalities in adulthood by approximately 70%, including hypertension, dyslipidemia, insulin resistance, hyperuricemia, and non-alcoholic fatty liver disease. In Mexico, overweight and obesity affect 35.5% of school-aged children, inevitably contributing to the growing prevalence of non-communicable chronic diseases. Data from ENSANUT 2018 place Sonora among the five states with the highest rates of obesity, with 22.2% of adolescents aged 12-19 years classified as obese. This epidemiological context highlights the pressing need for innovative strategies to promote prevention and early risk detection during childhood.
Evidence indicates that mobile health (mHealth) applications may effectively reduce body weight and prevent fat accumulation. Nevertheless, only a limited number of studies have applied mHealth interventions to prevent pediatric adiposity or to foster behavioral changes in comparison with conventional nutritional approaches. The proposed model incorporates a communication strategy designed to monitor participant needs, offer engagement incentives, and promote adherence to the study protocol.
The primary research question addresses whether a family-focused intervention can effectively improve eating patterns and food-related behaviors among students enrolled at "La Caridad" Educational Center in Nacozari de García, Sonora.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nutritional therapy supported by a mobile application.
Conventional nutritional treatment.
Time frame: Six months
The Children's Eating Behavior Questionnaire (CEBQ) will be administered. The responses will be scored and interpreted using standardized scales, yielding two main dimensions: overeating-related behaviors (where higher scores indicate increased risk of obesity) and undereating-related behaviors (where higher scores suggest risk of underweight or feeding difficulties). Each dimension is further divided into four subscales, allowing for a more detailed characterization of eating behavior patterns.
Time frame: Six months
Measured in Kg/m2
Time frame: Six months
Years lived reported by parents through medical records
Time frame: Six months
Comprehensive Feeding Practices Questionnaire (CFPQ). The CFPQ evaluates parental feeding behaviors across two primary domains, each comprising six subscales. The first domain encompasses health-promoting feeding practices (e.g., modeling, monitoring), while the second includes negative or problematic feeding practices (e.g., use of food as a reward, restrictive practices). Higher scores in health-promoting practices are positively associated with healthier dietary patterns in children. In contrast, higher scores in negative practices are linked to an increased risk of pediatric obesity and disordered eating behaviors.
Time frame: Six months
The total body weight (kg) observed in the intervention group versus the control group.
Time frame: Six months
This questionnaire assesses children's average physical activity (expressed in MET-minutes per week) and sedentary time (in hours/day) across weekdays
Time frame: Six months
Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.
Time frame: Six months
Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Time frame: Six months
Children's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Time frame: Six months
Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)
Time frame: Six months
Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)
Time frame: Six months
Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).
Time frame: Six months
Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).
Time frame: Six months
Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.
Time frame: Six months
The Short Parenting Practices Questionnaire is designed to identify and classify parenting styles based on two primary dimensions: warmth (affection) and control (discipline).
In its abbreviated version, the questionnaire asks parents/caregivers to report on items that explore:
Authoritative practices: characterized by high warmth and high control, reflected in behaviors such as providing explanations, setting clear rules, showing affection, and promoting autonomy within appropriate limits.
Authoritarian practices: characterized by low warmth and high control, reflected in behaviors such as rigid discipline, imposing rules without dialogue, and lower expression of affection.
In general, the questionnaire requires self-reported responses regarding the frequency with which parents engage in specific behaviors or strategies in everyday life. These responses are then grouped into the two empirically validated categories.
Time frame: Six month
Using data collected from a food frequency questionnaire (FFQ) and a 24-hour dietary recall will be evaluated for dietary patterns
Time frame: Six months
Change in Z-score scale:
Contact information is provided by the study sponsor or research team.
Claudia Teresa Tovar Palacio
Other
Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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