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Community-based Program to Treat Childhood Obesity

Sponsor
UnitedHealth Group (Industry)
Overall Status
Completed
CT.gov ID
NCT01374646
Collaborator
(none)
155
Enrollment
1
Location
17.1
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: JOIN Intervention
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
155 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Jun 5, 2012
Actual Study Completion Date :
Jun 5, 2012

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. Process Outcomes [6 Months]

    Assess process outcomes measures, such as attendance and program satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 YMCA of Greater Providence Providence Rhode Island United States 02903

Sponsors and Collaborators

  • UnitedHealth Group

Investigators

  • Principal Investigator: Deneen Votja, MD, UnitedHealth Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01374646
Other Study ID Numbers:
  • JOIN2011 10-309
First Posted:
Jun 16, 2011
Last Update Posted:
Jun 23, 2021
Last Verified:
Jun 1, 2021
Keywords provided by , ,
Childhood Obesity
Group Treatment
Community-based Programs
Additional relevant MeSH terms:
Obesity
Pediatric Obesity

Study Results

No Results Posted as of Jun 23, 2021