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Community-based Program to Treat Childhood Obesity

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JOIN Intervention
Sponsored by
UnitedHealth Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood Obesity, Group Treatment, Community-based Programs

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • YMCA of Greater Providence

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 14, 2011
Last Updated
June 21, 2021
Sponsor
UnitedHealth Group
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1. Study Identification

Unique Protocol Identification Number
NCT01374646
Brief Title
Community-based Program to Treat Childhood Obesity
Official Title
Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
June 5, 2012 (Actual)
Study Completion Date
June 5, 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UnitedHealth Group

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity, Group Treatment, Community-based Programs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
JOIN Intervention
Intervention Description
Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
Primary Outcome Measure Information:
Title
Change in weight and body mass index (BMI) in children and teens at 6 months
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change in weight and BMI in parent/guardian/care giver at 6 months
Description
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.
Time Frame
6 months
Title
Change in physical activity level in children and teens at 6 months
Description
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.
Time Frame
6 months
Title
Changes in intake and sedentary behavior at 6 months
Description
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.
Time Frame
6 months
Title
Process Outcomes
Description
Assess process outcomes measures, such as attendance and program satisfaction.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deneen Votja, MD
Organizational Affiliation
UnitedHealth Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
YMCA of Greater Providence
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Community-based Program to Treat Childhood Obesity

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