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Nutrition Study for School Age Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620152
First Posted: February 21, 2008
Last Update Posted: August 24, 2010
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.
Collaborators:
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Boston Children’s Hospital
  Purpose
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 Intervention
Obesity Behavioral: 1 Behavioral: 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Boston Children’s Hospital:

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

Estimated Enrollment: 40
Study Start Date: April 2008
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

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 Submitted: February 19, 2008
First Posted: February 21, 2008
Last Update Posted: August 24, 2010
Last Verified: August 2010

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