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

2013. augusztus 16. frissítette: Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey

Individualized Tailor-made Dietetic Intervention Program at Schools Enhances Eating Behaviors and Dietary Habits in Obese Hispanic Children of Low Socioeconomic Status

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Részletes leírás

Study Population An open invitation is made to children from eight public schools of low socioeconomic status (low SES), representative of all geographical areas of Monterrey, second largest city in México. From those that accept, children will be randomly selected and screened for overweight/obesity using BMI percentiles, and those who qualify for overweight/obesity will be invited to participate in the dietetic intervention program.

Clinical Evaluation Based on the World Health Organization and the American Academy of Pediatrics criteria (BA, Spear, et al., 2007), overweight is considered as BMI > 85th and < 95th percentiles and obesity as > 95th percentile according to age and sex. Anthropometric measurements will be performed in all participants at each school. Standing height will be determined to the nearest 0.5 cm (portable Seca® stadiometer, North America) and weight to the nearest 0.1 kg while children wear light clothing, no socks or shoes (TANITA TBF 300® scale, Arlington, Illinois). Waist circumference will be measured to the nearest 0.1 cm at the level of the umbilicus with a flexible fiberglass tape while the subjects are standing, after gently exhaling, and with no clothing on the area. BMI will be calculated by weight (kg) divided by the square of height (m). Measurements will be performed by the same three trained registered dietitians (RD) in all children to control the inter-observer variability.

Dietetic Intervention The principal strategies for the change in energy and food groups consumption, are dietary modifications for the children and parental support, as recommended by national associations (SR, Daniels et al, 2009; TA, Nicklas, et al, 2008; BA, Spear, et al., 2007, A Report of the Panel on Macronutrients et al, 2005). Dietetic intervention will be given individually by a RD for every child at each school, every three weeks, for a total of 13 visits during the school-year. Children will leave the classroom to attend the 30-minute nutrition counseling. Each child will be seen by the same RD throughout the school-year to favor compliance to the plan and to avoid inter-examiner bias. Each session will consist of: 1.) Anthropometric assessment; 2.) Dietetic assessment by means of 24-hour diet recalls, a standardized food frequency questionnaire that included Mexican foods, and food replicas to aid in estimation of portion sizes; 3.) Individualized energy restriction and balanced macronutrient dietary planning; 4.) Provision of structured, tailored-made daily menus and meals for the next three weeks for each child; and 5.) Information given to parents/care givers about healthy food, eating practices and portion sizes. Attendance of the parent/care giver is mandatory to help answer the 24-hour recalls and to assure commitment to follow the dietary recommendations at home. After each visit, the RD will record the information into the software (NutriKcal®VO software, Consinfo S.C., D.F., Mexico.), which determines energy intake and diet composition.

Diet composition (macronutrients) is based on the most recent dietary recommended intake for children (A Report of the Panel on Macronutrients et al, 2005) : 25%-35% of total calories from fat; 45%-65% from carbohydrates and 10%-30% from protein. Additional recommendations for children or adolescents include a variety of foods low in saturated fat (<10% kcal), no trans fat and cholesterol <300 mg/day. The RDs will promote age appropriate serving sizes, including approximately >5 servings of fruit and vegetables, >3 servings of low fat milk or dairy products, >6 servings of whole-grain products per day; increase of dietary fiber and reduction of salt intake (US Department of Agriculture and US Department of Health and Human Services, 2010). As well, children will be advised to avoid overconsumption of energy dense, nutrient-poor foods and beverages (TA, Nicklas et al, 2008).

Reduction in calorie intake is approached following the recommendations of the American Heart Association in which children > 4 years old with a BMI > 85th percentile to achieve BMI percentile reductions to <85th percentile with weight maintenance during linear growth (SR, Daniels, et al, 2009). As advised (BA, Spear, et al, 2007), progressive restriction of 150-900 calories from actual intake throughout the school year is recommended so that obese children with BMI >95th percentile lose gradually 0.5 kilogram/month and those with BMI >99th percentile lose a maximum of 0.9 kilogram/week.

Statistical Methods MINITAB version 16 (Minitab Inc., State College, Pennsylvania, USA) will be used to analyze the differences between anthropometric parameters and nutrient intake values at baseline and end of intervention; Microsoft Excel 2007 (Microsoft Corp., Redmond, Washington, USA) will be used to incorporate the input of data. The results will be expressed as mean ± standard deviation (s.d.) and their corresponding 95% confidence intervals (CI). Comparisons between groups for dependent variables will be made using paired Student's t-test for means. The mean comparisons between gender groups will be determined using t-test for independent samples. All tests will be interpreted based on two-tailed hypothesis. The significance level will be set at 0.05 in all cases.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

105

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexikó, 64710
        • Clinical Nutrition and Obesity Research Center. School of Medicine and Health Sciences, TEC Salud, Tecnológico de Monterrey

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

6 év (Gyermek)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Egyéb: Individualized dietetic intervention
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.
Más nevek:
  • tailor-made dietetic intervention

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change from baseline in energy dense food consumption at 12 months
Időkeret: 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
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change from baseline in waist circumference at 12 months
Időkeret: 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.
12 months
Change from baseline in total energy intake at 12 months
Időkeret: 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.
12 months
Change from baseline in carbohydrate consumption at 12 months
Időkeret: 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.
12 months
Change from baseline in protein consumption at 12 months
Időkeret: 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.
12 months
Change from baseline in fat consumption at 12 months
Időkeret: 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.
12 months
Change from baseline in water consumption at 12 months
Időkeret: 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.
12 months
Change from baseline in body mass index percentile at 12 months
Időkeret: 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.
12 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Leticia Elizondo-Montemayor, M.D., Instituto Tecnologico y de Estudios Superiores de Monterrey

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2011. augusztus 1.

Elsődleges befejezés (Tényleges)

2012. július 1.

A tanulmány befejezése (Tényleges)

2012. július 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2013. augusztus 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2013. augusztus 16.

Első közzététel (Becslés)

2013. augusztus 20.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Becslés)

2013. augusztus 20.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2013. augusztus 16.

Utolsó ellenőrzés

2013. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • DIETARYHABITS2012-CINCO

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