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OverweightNCT01925976

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

A study testing Individualized dietetic intervention-eating habits in people with Overweight and Obesity, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Overweight, Obesity
What is being tested?
Individualized dietetic intervention-eating habits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteMexico
Study dates
Aug 2011to Jul 2012
Phase
Interventional
Are there results?
None posted in the registry

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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

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

    Monterrey, Nuevo León, 64710

Other trials in Mexico

About this study

Official title: 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.

Read the detailed description

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.

Conditions
Overweight, Obesity
Being tested
Individualized dietetic intervention-eating habits
Keywords
obesity, dietetic intervention, eating behaviors, children, healthy eating, energy dense foods
Medical subject headings
Overweight, Obesity, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized dietetic intervention-eating habitsBehavioural

    Also called tailor-made dietetic intervention

    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.

Study groups in NCT01925976
Study groupRoleWhat they receive
Individualized dietetic interventionOtherBehavioral: Individualized dietetic intervention-eating habits.
Receives: Behavioral: Individualized dietetic intervention-eating habits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (7)

  1. Change from baseline in waist circumference at 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.

    Measured: 12 months

  2. Change from baseline in total energy intake at 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.

    Measured: 12 months

  3. Change from baseline in carbohydrate consumption at 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.

    Measured: 12 months

  4. Change from baseline in protein consumption at 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.

    Measured: 12 months

  5. Change from baseline in fat consumption at 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.

    Measured: 12 months

  6. Change from baseline in water consumption at 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.

    Measured: 12 months

  7. Change from baseline in body mass index percentile at 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2013 (estimated)
  2. Study startAug 2011
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01925976
Sponsor's protocol ID
DIETARYHABITS2012-CINCO
Status last verified
Aug 2013
First submitted
14 Aug 2013
Last updated
20 Aug 2013
Results posted
No
Data monitoring committee
No

Publications

  • Daniels SR, Jacobson MS, McCrindle BW, Eckel RH, Sanner BM. American Heart Association Childhood Obesity Research Summit Report. Circulation. 2009 Apr 21;119(15):e489-517. doi: 10.1161/CIRCULATIONAHA.109.192216. Epub 2009 Mar 30. No abstract available.

    PubMed 19332458

  • 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

  • Elizondo-Montemayor L, Serrano-Gonzalez M, Ugalde-Casas PA, Cuello-Garcia C, Borbolla-Escoboza JR. Metabolic syndrome risk factors among a sample of overweight and obese Mexican children. J Clin Hypertens (Greenwich). 2010 May;12(5):380-7. doi: 10.1111/j.1751-7176.2010.00263.x.

    PubMed 20546382

  • Cook S, Weitzman M, Auinger P, Nguyen M, Dietz WH. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey, 1988-1994. Arch Pediatr Adolesc Med. 2003 Aug;157(8):821-7. doi: 10.1001/archpedi.157.8.821.

    PubMed 12912790

  • Fuentes-Afflick E, Hessol NA. Overweight in young Latino children. Arch Med Res. 2008 Jul;39(5):511-8. doi: 10.1016/j.arcmed.2008.02.008. Epub 2008 Apr 8.

    PubMed 18514096

  • Mazur RE, Marquis GS, Jensen HH. Diet and food insufficiency among Hispanic youths: acculturation and socioeconomic factors in the third National Health and Nutrition Examination Survey. Am J Clin Nutr. 2003 Dec;78(6):1120-7. doi: 10.1093/ajcn/78.6.1120.

    PubMed 14668273

  • Rodriguez-Ramirez S, Mundo-Rosas V, Garcia-Guerra A, Shamah-Levy T. Dietary patterns are associated with overweight and obesity in Mexican school-age children. Arch Latinoam Nutr. 2011 Sep;61(3):270-8.

    PubMed 22696895

  • Eagle TF, Sheetz A, Gurm R, Woodward AC, Kline-Rogers E, Leibowitz R, Durussel-Weston J, Palma-Davis L, Aaronson S, Fitzgerald CM, Mitchell LR, Rogers B, Bruenger P, Skala KA, Goldberg C, Jackson EA, Erickson SR, Eagle KA. Understanding childhood obesity in America: linkages between household income, community resources, and children's behaviors. Am Heart J. 2012 May;163(5):836-43. doi: 10.1016/j.ahj.2012.02.025.

    PubMed 22607862

  • 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.

    PubMed 17510091

  • 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.

    PubMed 22863369

  • Ogden CL, Lamb MM, Carroll MD, Flegal KM. Obesity and socioeconomic status in children and adolescents: United States, 2005-2008. NCHS Data Brief. 2010 Dec;(51):1-8.

    PubMed 21211166

  • Nicklas TA, Hayes D; American Dietetic Association. Position of the American Dietetic Association: nutrition guidance for healthy children ages 2 to 11 years. J Am Diet Assoc. 2008 Jun;108(6):1038-44, 1046-7. doi: 10.1016/j.jada.2008.04.005.

    PubMed 18564454

  • 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.

    PubMed 18055654

  • 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.

    PubMed 19288844

Questions about this trial

What is this clinical trial studying?

A study testing Individualized dietetic intervention-eating habits in people with Overweight and Obesity, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in energy dense food consumption at 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01925976, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.

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