Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
Primary Purpose
Pediatric Obesity, Pediatric Overweight
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multifamily weight management intervention
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Obesity focused on measuring pediatric obesity, pediatric overweight, multi-family group weight management intervention, financial rewards
Eligibility Criteria
Inclusion Criteria:
- patient age 8-17 years
- patient with public insurance managed by Children's Community Health Network
- English speaking patient and parent
- patient body mass index at or above the 85th percentile for age and sex
- parent or legal guardian willing to participate
Exclusion Criteria:
- significant patient developmental or cognitive delay
- concurrent involvement in another formal weight management program.
Sites / Locations
- Medical College of Wisconsin/Children's Hosptial of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Multifamily group weight management intervention plus rewards for program attendance
Multifamily group weight management intervention plus rewards for attendance and goal attainment
Outcomes
Primary Outcome Measures
dietary habits
physical and sedentary activity
Secondary Outcome Measures
body mass index
participant satisfaction
Full Information
NCT ID
NCT00863083
First Posted
March 16, 2009
Last Updated
June 17, 2010
Sponsor
Medical College of Wisconsin
Collaborators
Children's Health System, Inc., Wisconsin Department of Health and Family Services
1. Study Identification
Unique Protocol Identification Number
NCT00863083
Brief Title
Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
Official Title
Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to poor enrollment.
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Children's Health System, Inc., Wisconsin Department of Health and Family Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to examine the extent to which two different reward systems implemented in the context of a multi-family pediatric weight management group differentially promote adoption of healthy eating and activity habits among overweight and obese 8-17 year old youth. Participants will be randomly assigned to one of two reward conditions: rewards for attendance only or rewards for attendance and goal attainment. We hypothesize that all participants will demonstrate significant increases in healthy nutritional choices and physical activity and significant reductions in sedentary activity from pre-intervention to post intervention. We expect that participants in attendance plus goal attainment reward condition will demonstrate significantly greater improvements than participants in the attendance only condition.
Detailed Description
Pediatric overweight and obesity are significant public health concerns, and group based interventions incorporating behavioral, nutrition, and activity disciplines have showed modest success in improving youth health and weight status. The role of financial rewards in encouraging attendance at weight management sessions and acquisition of healthy eating and activity habits is not well understood in the context of pediatric weight management, however. Behavior theory suggests that positive reinforcement can increase the frequency of desirable behaviors. As such, the primary goal of the study is to evaluate the role of different reinforcement systems in increasing healthy nutritional choices, increasing physical activity, and decreasing sedentary activity among youth participating in a multifamily group based pediatric overweight/obesity intervention program. An additional aim of the study is to evaluate the role of different levels of rewards in decreasing BMI among youth participating in a multifamily group based pediatric overweight/obesity intervention program. Participants will be randomly assigned to one of two different reward conditions: Condition A (rewards for attendance only) and Condition A+G (rewards for attendance and goal attainment).
Up to 80 participants will be recruited to participate. Eligibility criteria include patient age 8-17 years, patient with public insurance managed by Children's Community Health Network, English speaking patient and parent, and patient body mass index at or above the 85th percentile for age and sex. Exclusion criteria include: significant patient developmental or cognitive delay, or concurrent involvement in another formal weight management program.
Pre and post intervention assessments of anthropometric, psychosocial, nutritional, and physical fitness variables will be conducted, and participants will complete 8 weekly multi-family group-based weight management intervention sessions involving psychology, physical therapy, and dietitian disciplines. Following this intensive phase, families will follow up on a quarterly basis for one year. Families will receive financial rewards for attending program sessions (Conditions A and A+G) and for completing behavioral monitoring assignments (Condition A+G).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Pediatric Overweight
Keywords
pediatric obesity, pediatric overweight, multi-family group weight management intervention, financial rewards
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Multifamily group weight management intervention plus rewards for program attendance
Arm Title
2
Arm Type
Active Comparator
Arm Description
Multifamily group weight management intervention plus rewards for attendance and goal attainment
Intervention Type
Behavioral
Intervention Name(s)
Multifamily weight management intervention
Intervention Description
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.
Primary Outcome Measure Information:
Title
dietary habits
Time Frame
pre, post, quarterly follow ups
Title
physical and sedentary activity
Time Frame
pre, post, quarterly follow ups
Secondary Outcome Measure Information:
Title
body mass index
Time Frame
pre, post, quarterly follow ups
Title
participant satisfaction
Time Frame
post intevention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient age 8-17 years
patient with public insurance managed by Children's Community Health Network
English speaking patient and parent
patient body mass index at or above the 85th percentile for age and sex
parent or legal guardian willing to participate
Exclusion Criteria:
significant patient developmental or cognitive delay
concurrent involvement in another formal weight management program.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Neff Greenley, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin/Children's Hosptial of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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