Clinical trial NCT00620152: Nutrition Study for School Age Children
Official title: Randomized Trial of Telephone Interventions for Pediatric Obesity in School Age Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in diet
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Erinn Rhodes, MD
role: STUDY_DIRECTOR
affiliation: Boston Children's Hospital
name: David S Ludwig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes ET, Vernacchio L, Mitchell AA, Fischer C, Giacalone P, Ludwig DS, Ebbeling CB. A telephone intervention to achieve differentiation in dietary intake: a randomized trial in paediatric primary care. Pediatr Obes. 2017 Dec;12(6):494-501. doi: 10.1111/ijpo.12171. Epub 2016 Aug 5.