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Completed

NCT Number: NCT00620152

Nutrition Study for School Age Children

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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Key information

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1

Behavioral

Low glycemic load diet by telephone counseling

2

Behavioral

Low fat diet by telephone counseling

Primary outcomes

  1. Change in diet

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Boston University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Important dates

Study start
2008
First posted
Feb 21, 2008
Registry last updated
Aug 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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