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Clinical Trials/NCT00620152
NCT00620152CompletedNot Applicable

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

Boston Children's Hospital1 site in 1 country40 target enrollmentStarted: April 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Change in diet

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1

Experimental

Low glycemic load diet

Intervention: 1 (Behavioral)

2

Active Comparator

Low fat diet

Intervention: 2 (Behavioral)

Outcomes

Primary Outcomes

Change in diet

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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