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Nutrition Study for School Age Children

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ClinicalTrials.gov Identifier: NCT00620152
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : August 24, 2010
Sponsor:
Collaborators:
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Boston Children’s Hospital

Brief Summary:
In this study, we evaluate whether dietary advice based on two healthy nutritional programs can be effectively delivered to families over one month by telephone. We hypothesize that among overweight school age children, a one-month telephone intervention will result in specific dietary changes consistent with the randomly assigned dietary intervention.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: 1 Behavioral: 2 Not Applicable

Detailed Description:
Overweight and obesity have increasingly become problems faced by children. However, the best dietary approach for managing weight in children remains unclear and how to make dietary advice practical remains a challenge. The primary aim of the study is to evaluate the feasibility of a one-month telephone-based dietary intervention for pediatric obesity in achieving changes in the target variable (dietary glycemic load or dietary fat) of the assigned intervention. We hypothesis that among overweight school age children, a one-month telephone intervention will elicit specific dietary changes consistent with the randomly assigned prescriptions. Specifically, children counseled to reduce glycemic load will achieve a significantly greater mean reduction in glycemic load than those counseled to reduced dietary fat and, conversely, those counseled to reduce dietary fat will achieve a significantly greater mean reduction in dietary fat than those counseled to reduce glycemic load. The first ten participants enrolled will comprise a pilot study group intend to inform study design/methods and will not be included in the primary analysis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children
Study Start Date : April 2008

Arm Intervention/treatment
Experimental: 1
Low glycemic load diet
Behavioral: 1
Low glycemic load diet by telephone counseling
Active Comparator: 2
Low fat diet
Behavioral: 2
Low fat diet by telephone counseling



Primary Outcome Measures :
  1. Change in diet [ Time Frame: 1 month ]


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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI ≥ 85%ile for age and sex within the last 6 months
  • Living at home with a working telephone.
  • Subject conversant in English
  • Parent/guardian conversant and literate in English
  • Family readiness to make dietary changes

Exclusion Criteria:

  • Major chronic medical illness (e.g., cancer)
  • Psychiatric disorder
  • Obesity-associated genetic syndrome
  • Current participation in another obesity-related research study or a formal weight loss program
  • Family or child following a specialized diet
  • Related to or living with another child study participant

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): NCT00620152


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Director: Erinn Rhodes, MD Boston Children’s Hospital
Principal Investigator: David S Ludwig, MD Boston Children’s Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00620152     History of Changes
Other Study ID Numbers: X08-01-0047 (completed)
5R01DK059240 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: August 24, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms