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

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ClinicalTrials.gov Identifier: NCT01840631
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Lisa Underland, Albert Einstein College of Medicine

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Nutritional Counseling Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Actual Study Start Date : April 2013
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018

Arm Intervention/treatment
Active Comparator: Group nutritional counseling
In this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group
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.

Active Comparator: Individual nutritional counseling
In this arm the nutritionist conducts the nutritional counseling with one patient family at a time
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.




Primary Outcome Measures :
  1. Change I Mean Body Mass Index [ Time Frame: Baseline, month 6 ]
    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.


Secondary Outcome Measures :
  1. Change in BMI with diet [ Time Frame: Baseline, month 6 ]
    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.

  2. Change in BMI with physical activity [ Time Frame: Baseline, month 6 ]
    The study will assess if there is a change in BMI with increased physical activity

  3. Change in BMI with metabolic profile [ Time Frame: Baseline, month 6 ]
    Study will assess if the change in BMI affects Metabolic profile of the subject.



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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840631


Locations
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United States, New York
Albert Einstein College of Medicine West Campus CRC
Bronx, New York, United States, 10467
Sponsors and Collaborators
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Lisa Underland, MD Albert Einstein College of Medicine

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Responsible Party: Lisa Underland, Asst. Professor, Pediatrics, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01840631     History of Changes
Other Study ID Numbers: 2012-214
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Lisa Underland, Albert Einstein College of Medicine:
Obesity
Nutritional counseling
Physical activity
Food diary
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms