Nutrition Study for School Age Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Behavioral: 1 Behavioral: 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children |
- Change in diet [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Low glycemic load diet
|
Behavioral: 1
Low glycemic load diet by telephone counseling
|
|
Active Comparator: 2
Low fat diet
|
Behavioral: 2
Low fat diet by telephone counseling
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 10 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Study Director: | Erinn Rhodes, MD | Children's Hospital Boston |
| Principal Investigator: | David S Ludwig, MD | Children's Hospital Boston |
More Information
No publications provided
| Responsible Party: | David Ludwig, MD, PhD, Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT00620152 History of Changes |
| Other Study ID Numbers: | X08-01-0047 (completed), 5R01DK059240 |
| Study First Received: | February 19, 2008 |
| Last Updated: | August 20, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013