- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00620152
Nutrition Study for School Age Children
August 20, 2010 updated by: Boston Children's Hospital
Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children
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.
Study Overview
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
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Children's Hospital Boston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Low glycemic load diet
|
Low glycemic load diet by telephone counseling
|
Active Comparator: 2
Low fat diet
|
Low fat diet by telephone counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in diet
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Erinn Rhodes, MD, Boston Children's Hospital
- Principal Investigator: David S Ludwig, MD, Boston Children's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Study Registration Dates
First Submitted
February 19, 2008
First Submitted That Met QC Criteria
February 19, 2008
First Posted (Estimate)
February 21, 2008
Study Record Updates
Last Update Posted (Estimate)
August 24, 2010
Last Update Submitted That Met QC Criteria
August 20, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- X08-01-0047 (completed)
- 5R01DK059240 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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