Overweight and/or ObesityNCT07159971
Family-Based Nutrition Intervention to Prevent Overweight and Obesity in School-Age Children.
A study testing School B in people with Overweight and/or Obesity and Children - Malnutrition, run by Claudia Teresa Tovar Palacio at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and/or Obesity, Children - Malnutrition, Preventing Malnutrition
- What is being tested?
- School B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 30 Jun 2025to 1 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families of children between 5 and 9 years old.
- Children without any medical or nutritional treatment for obesity.
- Children classified as normal weight, overweight, or obese based on WHO (Z-score: height for age and BMI for age).
- Offspring of mothers aged between 18 and 45 years at delivery.
- Term infants from normoevolutive pregnancies without maternal comorbidities.
- Families who have a cell phone with internet access and an installed camera.
Who cannot join
- Children who are currently suffering from a pathology that requires medication or special treatment
- Mothers/Fathers/Guardians who are currently suffering from a pathology that requires medication or special treatment.
- Children who have a physical/mental impairment to perform physical activities.
- Children from surrogate mothers who have presented at least 2 of the 11 DSM-5 criteria for substance use disorder (alcohol, tobacco, cannabis, or other illegal drugs) before or during the participating child's gestation.
- Children from multiple pregnancies.
- Parents who do not own a smartphone compatible with the app will be excluded from this study (i.e., version 5.0 or higher for Android).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
"El globo" and "Servicios de Salud Lomas Altas"
México, Sonora
Claudia Tovar-Palacio, Ph.D., +52 5585341831, claudia.tovarp@incmnsz.mx
Fernanda Martinez García, M.Sc., +525549398899, maria.martinezg@incmnsz.mx
About this study
Official title: Family-based Intervention Model to Prevent Childhood Obesity Among Schoolage Children in Sonora, Mexico.
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.
Read the detailed description
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.
- Being tested
- School B, Control
- Keywords
- Obesity, Children, mHealth, Intervention, Family-base
- Medical subject headings
- Child Nutrition Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School BDevice
Nutritional therapy supported by a mobile application.
ControlOther
Conventional nutritional treatment.
| Study group | Role | What they receive |
|---|---|---|
| School B | Experimental | Nutritional therapy supported by a mobile application. The app integrates a multimodal approach (educational content, interactive tools, and gamification) to promote healthy eating, featuring parent-child dyad-focused resources such as recipe tutorials with family-specific adaptations. Receives: Device: School B |
| School A. | Active comparator | Nutritional therapy will be delivered through a mobile application that will integrate a multimodal approach, including educational content, interactive tools, and gamification, to promote healthy eating. The application will incorporate parent-child dyad-focused resources, such as recipe tutorials adapted to specific family needs. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary behavior
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.
Measured: Six months
Body index mass
Measured in Kg/m2
Measured: Six months
Age
Years lived reported by parents through medical records
Measured: Six months
Feeding practices
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.
Measured: Six months
Body weight
The total body weight (kg) observed in the intervention group versus the control group.
Measured: Six months
Phisical activity
This questionnaire assesses children's average physical activity (expressed in MET-minutes per week) and sedentary time (in hours/day) across weekdays
Measured: Six months
Height
Mean values of anthropometric measurements obtained using a stadiometer, expressed in centimeters.
Measured: Six months
Fat mass
Children's fat mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Measured: Six months
Fat-free mass
Children's fat-free mass, as determined by bioelectrical impedance analysis, will be expressed as a percentage (%).
Measured: Six months
Glucose
Change in glucose concentration will be determined by measuring capillary blood glucose levels (mg/dL)
Measured: Six months
Triacylglycerides
Changes in triacylglycerol concentration will be determined by measuring capillary blood triacylglycerol levels (mg/dL)
Measured: Six months
Total cholesterol
Changes in total cholesterol concentration will be determined by measuring capillary blood cholesterol levels (mg/dL).
Measured: Six months
HDL-Cholesterol
Changes in HDL-cholesterol concentration will be determined by measuring capillary blood HDL-cholesterol levels (mg/dL).
Measured: Six months
LDL-cholesterol
Changes in LDL-cholesterol concentration will be determined by measuring capillary blood LDL-cholesterol levels.
Measured: Six months
Parenting practices
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.
Measured: Six months
Dietary patterns
Using data collected from a food frequency questionnaire (FFQ) and a 24-hour dietary recall will be evaluated for dietary patterns
Measured: Six month
Secondary outcomes (1)
Z-Score
Change in Z-score scale:
- - BMI for age: ≤-3SD is equivalent to severe thinness, ≤-2 is equivalent to thinness, ≥+2 is equivalent to obesity and ≥+1 is equivalent to overweight
- - Height for age: ≥ -1 is equivalent to normal, ≥-2 to ≤ -1 is equivalent to moderately stunted and ≤ -2 is equivalent to severely stunted
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start30 Jun 2025
- Primary completion31 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and/or ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Teresa Tovar Palacio
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Gonzalo Río Arronte, Instituto Nacional de Medicina Genomica, University of Illinois at Urbana-Champaign, Universidad Nacional Autonoma de Mexico
- Responsible party
- Sponsor-investigator, Claudia Teresa Tovar Palacio, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Claudia Tovar-Palacio, Ph.D., Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159971
- Sponsor's protocol ID
- 3738
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No