- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863083
Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Medical College of Wisconsin/Children's Hosptial of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Multifamily group weight management intervention plus rewards for program attendance
|
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.
|
|
Active Comparator: 2
Multifamily group weight management intervention plus rewards for attendance and goal attainment
|
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
dietary habits
Time Frame: pre, post, quarterly follow ups
|
pre, post, quarterly follow ups
|
|
physical and sedentary activity
Time Frame: pre, post, quarterly follow ups
|
pre, post, quarterly follow ups
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
body mass index
Time Frame: pre, post, quarterly follow ups
|
pre, post, quarterly follow ups
|
|
participant satisfaction
Time Frame: post intevention
|
post intevention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rachel Neff Greenley, PhD, Medical College of Wisconsin
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHW 08/101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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