NCT01840631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2013

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

5.2 years

First QC Date

March 8, 2013

Last Update Submit

October 10, 2018

Conditions

Obesity

Keywords

ObesityNutritional counselingPhysical activityFood diary

Outcome Measures

Primary Outcomes (1)

  • Change I Mean Body Mass Index

    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.

    Baseline, month 6

Secondary Outcomes (3)

  • Change in BMI with diet

    Baseline, month 6

  • Change in BMI with physical activity

    Baseline, month 6

  • Change in BMI with metabolic profile

    Baseline, month 6

Study Arms (2)

Group nutritional counseling

ACTIVE COMPARATOR

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

Behavioral: Nutritional Counseling

Individual nutritional counseling

ACTIVE COMPARATOR

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

Behavioral: Nutritional Counseling

Interventions

Nutritional CounselingBEHAVIORAL

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.

Group nutritional counselingIndividual nutritional counseling

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine West Campus CRC

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Lisa Underland, MD

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Professor, Pediatrics

Study Record Dates

First Submitted

March 8, 2013

First Posted

April 26, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Locations

US(1)