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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

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