NCT01925976

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

August 14, 2013

Last Update Submit

August 16, 2013

Conditions

Keywords

obesitydietetic interventioneating behaviorschildrenhealthy eatingenergy dense foods

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

OTHER

Behavioral: Individualized dietetic intervention-eating habits.

Behavioral: 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.

Also known as: tailor-made dietetic intervention
Individualized dietetic intervention

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Location

Related Publications (30)

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  • Wang Y, Beydoun MA. The obesity epidemic in the United States--gender, age, socioeconomic, racial/ethnic, and geographic characteristics: a systematic review and meta-regression analysis. Epidemiol Rev. 2007;29:6-28. doi: 10.1093/epirev/mxm007. Epub 2007 May 17.

    PMID: 17510091BACKGROUND
  • Kendzor DE, Caughy MO, Owen MT. Family income trajectory during childhood is associated with adiposity in adolescence: a latent class growth analysis. BMC Public Health. 2012 Aug 5;12:611. doi: 10.1186/1471-2458-12-611.

    PMID: 22863369BACKGROUND
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    PMID: 21211166BACKGROUND
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    PMID: 18564454BACKGROUND
  • Spear BA, Barlow SE, Ervin C, Ludwig DS, Saelens BE, Schetzina KE, Taveras EM. Recommendations for treatment of child and adolescent overweight and obesity. Pediatrics. 2007 Dec;120 Suppl 4:S254-88. doi: 10.1542/peds.2007-2329F.

    PMID: 18055654BACKGROUND
  • Vereecken C, Legiest E, De Bourdeaudhuij I, Maes L. Associations between general parenting styles and specific food-related parenting practices and children's food consumption. Am J Health Promot. 2009 Mar-Apr;23(4):233-40. doi: 10.4278/ajhp.07061355.

    PMID: 19288844BACKGROUND
  • Mendoza JA, Watson K, Cullen KW. Change in dietary energy density after implementation of the Texas Public School Nutrition Policy. J Am Diet Assoc. 2010 Mar;110(3):434-40. doi: 10.1016/j.jada.2009.11.021.

    PMID: 20184994BACKGROUND
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    PMID: 19079319BACKGROUND
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    PMID: 15960869BACKGROUND
  • A Report of the Panel on Macronutrients, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of Dietary Reference Intakes, and the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes; Food and Nutrition Board; and Institute or Medicine. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: The National Academies Press [Internet]. United States: The National Academies Press, 2005 [cited 2012 July]. 1357 p. Available from: http://www.nap.edu/openbook.php?isbn=0309085373

    BACKGROUND
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    PMID: 22332062BACKGROUND
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    PMID: 18156411BACKGROUND
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    PMID: 18469244BACKGROUND
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    PMID: 12791618BACKGROUND
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    PMID: 19648176BACKGROUND
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    PMID: 20865095BACKGROUND
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  • Hingle MD, O'Connor TM, Dave JM, Baranowski T. Parental involvement in interventions to improve child dietary intake: a systematic review. Prev Med. 2010 Aug;51(2):103-11. doi: 10.1016/j.ypmed.2010.04.014. Epub 2010 May 10.

    PMID: 20462509BACKGROUND
  • Elizondo-Montemayor L, Moreno-Sanchez D, Gutierrez NG, Monsivais-Rodriguez F, Martinez U, Lamadrid-Zertuche AC, Hernandez-Torre MM. Individualized tailor-made dietetic intervention program at schools enhances eating behaviors and dietary habits in obese Hispanic children of low socioeconomic status. ScientificWorldJournal. 2014 Jan 30;2014:484905. doi: 10.1155/2014/484905. eCollection 2014.

MeSH Terms

Conditions

OverweightObesityFeeding Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Study Officials

  • Leticia Elizondo-Montemayor, M.D.

    Instituto Tecnologico y de Estudios Superiores de Monterrey

    PRINCIPAL INVESTIGATOR

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

Locations