Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity

Pediatric Obesity Clinical Trial

Official title:

Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00863083
• Other study ID #: CHW 08/101
• Status: Terminated
• Phase: N/A
• First received: March 16, 2009
• Last updated: June 17, 2010
• Start date: February 2009
• Est. completion date: July 2009

Study information

• Verified date: June 2010
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pediatric Obesity
• Pediatric Overweight

Intervention

Behavioral:
• Multifamily weight management intervention
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/Children's Hosptial of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Health System, Inc., Wisconsin Department of Health and Family Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dietary habits		pre, post, quarterly follow ups	No
Primary	physical and sedentary activity		pre, post, quarterly follow ups	No
Secondary	body mass index		pre, post, quarterly follow ups	No
Secondary	participant satisfaction		post intevention	No