Individualized Dietetic Intervention-eating Habits in Obese Hispanic Children of Low Socioeconomic Status
Individualized Tailor-made Dietetic Intervention Program at Schools Enhances Eating Behaviors and Dietary Habits in Obese Hispanic Children of Low Socioeconomic Status
1 other identifier
interventional
105
1 country
1
Brief Summary
The purpose of this study is to implement an individualized, face-to-face, parent supported and school-partnership dietetic intervention program to promote healthy eating habits in obese, Hispanic, children from low socioeconomic status due to the high predisposition to unhealthy eating habits and obesity in this population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 14, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedAugust 20, 2013
August 1, 2013
11 months
August 14, 2013
August 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in energy dense food consumption at 12 months
Energy dense food will include: processed meats, oils, saturated fat, sweets, sweetened beverages, desserts, refined-grain bakery, sweets, chips, fries, whole-fat milk, and fast foods. Measured in servings per day and servings per week. Results will be expressed in mean ± standard deviation for each and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.
12 months
Change from baseline in nutrient dense food consumption at 12 months
Nutrient dense food will include: fruits, vegetables, whole grains, beans and peas, fish/poultry. Measured in servings per day and servings per week. Results will be expressed in mean ± standard deviation for each and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.
12 months
Secondary Outcomes (7)
Change from baseline in waist circumference at 12 months
12 months
Change from baseline in total energy intake at 12 months
12 months
Change from baseline in carbohydrate consumption at 12 months
12 months
Change from baseline in protein consumption at 12 months
12 months
Change from baseline in fat consumption at 12 months
12 months
- +2 more secondary outcomes
Study Arms (1)
Individualized dietetic intervention
OTHERBehavioral: Individualized dietetic intervention-eating habits.
Interventions
The school-year (12 months) dietetic intervention consisted of anthropometric measurements, dietetic assessment, energy restriction tailor-made daily menus, and parental education every three weeks at each school site.
Eligibility Criteria
You may qualify if:
- Attendance from first to sixth grade
- Ages 6-12 years
- BMI ≥ 85th percentile for age and sex
- Hispanic origin
- Both parents Hispanic
- Low socioeconomic status
- Signed consent from both parents/care givers and active assent from children
You may not qualify if:
- Disapproval by the children's physician due to any at-risk medical condition known by the parents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, TecnolĂ³gico de Monterrey
Monterrey, Nuevo LeĂ³n, 64710, Mexico
Related Publications (30)
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PMID: 24592170DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leticia Elizondo-Montemayor, M.D.
Instituto Tecnologico y de Estudios Superiores de Monterrey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 14, 2013
First Posted
August 20, 2013
Study Start
August 1, 2011
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 20, 2013
Record last verified: 2013-08