Nutrition Study for School Age Children

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: 1; Behavioral: 2

• Registration Number: NCT00620152
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-21
• Study Start: 2008-04
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-20
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	1	Low glycemic load diet
2	2	Low fat diet

Primary Outcome Measures

Name	Time	Method
Change in diet	1 month

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States