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Sponsors and Collaborators: |
Children's Hospital Boston Boston University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00620152 |
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: | 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 |
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
|
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.
Ages Eligible for Study: | 5 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 |
Study Director: | Erinn Rhodes, MD | Children's Hospital Boston |
Principal Investigator: | David S Ludwig, MD | Children's Hospital Boston |
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 |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |