NCT01840631

A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity

A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Aim 1 - The primary aim of the study is to assess whether group counseling is a non-inferior intervention compared to the usual care of individual counseling in the management of childhood obesity. In order to achieve this aim, the investigators will compare the mean change in BMI after 6 months of intervention in the two study arms. Aim 2 - The secondary aim of the study is to determine if the change in BMI is associated with changes in the dietary composition, physical activity and metabolic profile.

Detailed description

This is a non-inferiority study to determine the sample size needed for a larger study to explore an intervention strategy focused on nutrition counseling to maximize weight loss and minimize cardiovascular risk factors in obese children and adolescents. This is a prospective parallel arm, randomized trial, to study the impact of nutritional counseling in an individual vs. group setting. There will be a total of four groups. Obese pre-adolescents (ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions: individual nutrition counseling or group nutrition counseling. Subjects will receive the same information in both interventions. All content will be developed prior to starting the intervention. Each group session will have a maximum of 7 children with 1 parent/caregiver per child and a minimum of 5 children with a caregiver. Group sessions will be one time a month for 60 minutes (30 minutes for dietetic session and 30 minutes for discussion/questions) and individual sessions will be one time a month for 30 minutes. There will be 6 sessions for each group. All groups will receive standard of care for physical fitness counseling which includes recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours a day. All groups will be evaluated for depression and appropriately referred if found to be depressed. Behavioral strategies, like mindful eating, will be included in the nutrition education.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Nutritional Counseling	Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes. Classes will meet one time a month. Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-04-26
• Last updated: 2018-10-12

Locations

1 site across 1 country: United States