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

NCT ID: NCT01840631

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2018-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group nutritional counseling

In this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Individual nutritional counseling

In this arm the nutritionist conducts the nutritional counseling with one patient family at a time

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjects 9-17 years of age with a BMI percentile for age of ≥95
• Subjects must be able to attend monthly sessions with a parent and/or guardian.

Exclusion Criteria

• Subjects with diabetes at baseline, mental or psychological disease that would interfere with understanding, disease or medication causing obesity or weight loss, and participants in an alternative weight management program will not be included in the study.
• Subjects with impaired glucose tolerance will not be excluded from participation.
• Non-English speaking subjects will not be excluded.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Lisa Underland

Asst. Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Underland, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Albert Einstein College of Medicine West Campus CRC

The Bronx, New York, United States

Countries

United States

Other Identifiers

2012-214

Identifier Type: -

Identifier Source: org_study_id