Community-based Program to Treat Childhood Obesity

Not Applicable

Completed

• Conditions: Childhood Obesity

• Registration Number: NCT01374646
• Lead Sponsor: UnitedHealth Group

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2011-06-14
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-16
• Primary Completion: 2012-06-05
• Study Completion: 2012-06-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-21
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in weight and body mass index (BMI) in children and teens at 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in weight and BMI in parent/guardian/care giver at 6 months	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.
Changes in intake and sedentary behavior at 6 months	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.
Process Outcomes	6 Months	Assess process outcomes measures, such as attendance and program satisfaction.
Change in physical activity level in children and teens at 6 months	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.

Trial Locations

Locations (1)

YMCA of Greater Providence; 🇺🇸 Providence, Rhode Island, United States