Clinical trial NCT01840631: A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Official title: A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Nutritional counseling
Physical activity
Food diary
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 90
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change I Mean Body Mass Index
timeFrame: Baseline, month 6
Secondary outcomes:
measure: Change in BMI with diet
timeFrame: Baseline, month 6
measure: Change in BMI with physical activity
timeFrame: Baseline, month 6
measure: Change in BMI with metabolic profile
timeFrame: Baseline, month 6
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine West Campus CRC
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Lisa Underland, MD
role: PRINCIPAL_INVESTIGATOR
References: