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.
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.
Brief Title
A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
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.
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.
Completion Date
Completion Date Type
Actual
Conditions
Obesity
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Obesity
Nutritional counseling
Physical activity
Food diary
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
17 Years
Minimum Age
9 Years
NCT Id
NCT01840631
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2012-214
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Primary Outcomes
Outcome Description
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, investigators will compare the mean change in BMI after 6 months of intervention in the two study arms. As per previous studies, it is expected the group intervention arm to achieve a mean BMI reduction of 0.8 +/- 1.4 greater than the control arm. The study also posits that a difference in mean BMI change as low as 0.1 would be clinically equivalent.
Outcome Measure
Change I Mean Body Mass Index
Outcome Time Frame
Baseline, month 6
Secondary Outcomes
Outcome Description
The secondary aim of the study is to determine if the change in BMI is associated with changes in the dietary composition. All the secondary outcomes will be measured by Pearson correlation coefficients or multi-variable linear regression models as appropriate to calculate this.
Outcome Time Frame
Baseline, month 6
Outcome Measure
Change in BMI with diet
Outcome Description
The study will assess if there is a change in BMI with increased physical activity
Outcome Time Frame
Baseline, month 6
Outcome Measure
Change in BMI with physical activity
Outcome Description
Study will assess if the change in BMI affects Metabolic profile of the subject.
Outcome Time Frame
Baseline, month 6
Outcome Measure
Change in BMI with metabolic profile
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
17
Minimum Age Number (converted to Years and rounded down)
9
Investigators
Investigator Type
Principal Investigator
Investigator Name
Lisa Underland
Investigator Email
lunderla@montefiore.org
Investigator Phone
832-867-4580