Nutrition Study for School Age Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: 1
* Behavioral: 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Low glycemic load diet | Behavioral: 1<br>* Low glycemic load diet by telephone counseling<br>|
| Active Comparator: 2<br>Low fat diet | Behavioral: 2<br>* Low fat diet by telephone counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diet |  | 1 month |