ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    17188606 [PUBMED-IDS]

Individualized Dietetic Intervention-eating Habits in Obese Hispanic Children of Low Socioeconomic Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01925976
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : August 20, 2013
Sponsor:
Information provided by (Responsible Party):
Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: Individualized dietetic intervention-eating habits Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualized Tailor-made Dietetic Intervention Program at Schools Enhances Eating Behaviors and Dietary Habits in Obese Hispanic Children of Low Socioeconomic Status
Study Start Date : August 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Individualized dietetic intervention
Behavioral: Individualized dietetic intervention-eating habits.
Behavioral: Individualized dietetic intervention-eating habits
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.
Other Name: tailor-made dietetic intervention




Primary Outcome Measures :
  1. Change from baseline in energy dense food consumption at 12 months [ Time Frame: 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.

  2. Change from baseline in nutrient dense food consumption at 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change from baseline in waist circumference at 12 months [ Time Frame: 12 months ]
    Waist circumference measured in centimeters. The results will be expressed as mean ± standard deviation and its corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  2. Change from baseline in total energy intake at 12 months [ Time Frame: 12 months ]
    Energy intake assessed according to a 24-hour food recall and reported in kilocalories per day. The results will be expressed as mean ± standard deviation and its corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  3. Change from baseline in carbohydrate consumption at 12 months [ Time Frame: 12 months ]
    Carbohydrate consumption will be expressed as energy intake in kilocalories per day, quantity in grams and percent of calories from the diet. The results will be expressed as mean ± standard deviation for each and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  4. Change from baseline in protein consumption at 12 months [ Time Frame: 12 months ]
    Protein consumption will be expressed as energy intake in kilocalories per day, quantity in grams and percent of calories from the diet. The results will be expressed as mean ± standard deviation for each and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  5. Change from baseline in fat consumption at 12 months [ Time Frame: 12 months ]
    Fat consumption will be expressed as energy intake in kilocalories per day, quantity in grams and percent of calories from the diet. The results will be expressed as mean ± standard deviation for each and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  6. Change from baseline in water consumption at 12 months [ Time Frame: 12 months ]
    Water consumption will be expressed as a mean ± standard deviation and its corresponding 95% confidence intervals for the mean difference at baseline and 12 months.

  7. Change from baseline in body mass index percentile at 12 months [ Time Frame: 12 months ]
    Body mass index (BMI) calculated by weight in kilograms (kg) divided by the square of height in meters (m). Measurements at baseline and 12 months. Results will be reported for BMI percentile according to the Body mass index-for-age percentiles: 2 to 20 years for boys and girls respectively, from the Centers for Disease and Control Prevention (CDC) Growth Charts: United States (http://www.cdc.gov/growthcharts). The results will be expressed as mean ± standard deviation and their corresponding 95% confidence intervals for the mean difference at baseline and 12 months.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Disapproval by the children's physician due to any at-risk medical condition known by the parents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925976


Locations
Mexico
Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo Leon, Mexico, 64710
Sponsors and Collaborators
Instituto Tecnologico y de Estudios Superiores de Monterey
Investigators
Principal Investigator: Leticia Elizondo-Montemayor, M.D. Instituto Tecnologico y de Estudios Superiores de Monterrey

Publications:
Secretaría de Salud. México avanza en la cobertura universal de salud: Felipe Calderón. México Sano. 2009;8:3
Olaiz-Fernández G, Rivera-Dommarco J, Shamah-Levy T, et al. Encuesta Nacional de Salud y Nutrición 2012: resultados nacionales [Internet]. Cuernavaca, México: Instituto Nacional de Salud Pública (MX) 2012 [cited 2012 July]. 200p. Available from: http://ensanut.insp.mx/informes/ENSANUT2012ResultadosNacionales.pdf
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leticia Elizondo-Montemayor, M.D., Instituto Tecnologico y de Estudios Superiores de Monterey
ClinicalTrials.gov Identifier: NCT01925976     History of Changes
Other Study ID Numbers: DIETARYHABITS2012-CINCO
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey:
obesity
dietetic intervention
eating behaviors
children
healthy eating
energy dense foods

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms