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Nutrition Study for School Age Children

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00620152
Enrollment
40
Registered
2008-02-21
Start date
2008-04-30
Completion date
Unknown
Last updated
2010-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

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.

Interventions

BEHAVIORAL1

Low glycemic load diet by telephone counseling

BEHAVIORAL2

Low fat diet by telephone counseling

Sponsors

Boston University
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frame
Change in diet1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026