Nutrition Study for School Age Children

This study has been completed.
Sponsor:
Collaborators:
Boston University
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00620152
First received: February 19, 2008
Last updated: August 20, 2010
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children

Resource links provided by NLM:


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

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
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

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: David Ludwig, MD, PhD, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00620152     History of Changes
Other Study ID Numbers: X08-01-0047 (completed), 5R01DK059240
Study First Received: February 19, 2008
Last Updated: August 20, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014