Overview

This trial is active, not recruiting.

Condition childhood obesity
Treatment join intervention
Sponsor UnitedHealth Group
Start date November 2010
End date August 2011
Trial size 150 participants
Trial identifier NCT01374646, JOIN2011 10-309

Summary

This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Change in weight and body mass index (BMI) in children and teens at 6 months
time frame: 6 Months

Secondary Outcomes

Measure
Change in weight and BMI in parent/guardian/care giver at 6 months
time frame: 6 months
Change in physical activity level in children and teens at 6 months
time frame: 6 months
Changes in intake and sedentary behavior at 6 months
time frame: 6 months
Process Outcomes
time frame: 6 Months

Eligibility Criteria

Male or female participants from 6 years up to 17 years old.

Inclusion Criteria - Children and teens between the ages of 6-17 - BMI percentile ≥85 - Participation of a parent/guardian Exclusion Criteria: - Enrollment in another weight loss program or study - Diagnosis of type 1 or type 2 diabetes - Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite - Medications (e.g., steroids) that affect weight or appetite - Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study

Additional Information

Official title Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
Principal investigator Deneen Votja, MD
Description This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study. This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include: - Parental involvement - Reduction in consumption of sugar sweetened beverages - Reduction of screen time - Self-monitoring - Physical activity - Stimulus control
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by UnitedHealth Group.