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NCT01374646 Clinical Trial

Community-based Program to Treat Childhood Obesity

Childhood Obesity Clinical Trial

Official title:
Effects of a Community-based Program to Treat Childhood and Adolescent Obesity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01374646
Other study ID # JOIN2011 10-309
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2011
Est. completion date June 5, 2012

Study information
Verified date June 2021
Source UnitedHealth Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 155
Est. completion date June 5, 2012
Est. primary completion date June 5, 2012
Accepts healthy volunteers No
Gender All
Age group 6 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• JOIN Intervention
Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.

Locations
Country Name City State
United States YMCA of Greater Providence Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in weight and body mass index (BMI) in children and teens at 6 months Assess the effects of a community based program on weight change in children ages 6-12 and teens ages 13-17. Assessments will occur at baseline, 3 and 6 months. 6 Months
Secondary Change in weight and BMI in parent/guardian/care giver at 6 months Assess the effects of a community based program on weight change in parent/guardian/care givers. Assessments will occur at baseline, 3 and 6 months. 6 months
Secondary Change in physical activity level in children and teens at 6 months Assess the effects of a community based program on physical activity level. Accelerometers will be used to access change at baseline, 3 and 6 months. 6 months
Secondary Changes in intake and sedentary behavior at 6 months Change in the number of sugar sweetened beverages consumed per day, hours per day on screen time (TV, video games, and computer), and quality of life at 6 months. Assessments will occur at baseline, 3 and 6 months. 6 months
Secondary Process Outcomes Assess process outcomes measures, such as attendance and program satisfaction. 6 Months
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