Nutrition Study for School Age Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Low glycemic load diet

Group Type EXPERIMENTAL

1

Intervention Type BEHAVIORAL

Low glycemic load diet by telephone counseling

2

Low fat diet

Group Type ACTIVE_COMPARATOR

2

Intervention Type BEHAVIORAL

Low fat diet by telephone counseling

Interventions

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1

Low glycemic load diet by telephone counseling

Intervention Type BEHAVIORAL

2

Low fat diet by telephone counseling

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes