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Nutrition Study for School Age Children
This study has been completed.
First Received: February 19, 2008   Last Updated: February 27, 2009   History of Changes
Sponsors and Collaborators: Children's Hospital Boston
Boston University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00620152
  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

MedlinePlus related topics: Diets Obesity Obesity in Children
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change in diet [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Arms Assigned Interventions
1: Experimental
Low glycemic load diet
Behavioral: 1
Low glycemic load diet by telephone counseling
2: Active Comparator
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

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620152

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Boston University
Investigators
Study Director: Erinn Rhodes, MD Children's Hospital Boston
Principal Investigator: David S Ludwig, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Children's Hospital Boston ( David Ludwig, MD, PhD )
Study ID Numbers: X08-01-0047
Study First Received: February 19, 2008
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00620152     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition

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

ClinicalTrials.gov processed this record on May 06, 2009