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

This study has been terminated.
(Study was terminated due to poor enrollment.)
Sponsor:
Collaborators:
Children's Health System, Inc.
Wisconsin Department of Health and Family Services
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00863083
First received: March 16, 2009
Last updated: June 17, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Pediatric Obesity
Pediatric Overweight
Behavioral: Multifamily weight management intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Barriers to Behavior Change Among Youth With Pediatric Overweight and Obesity

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • dietary habits [ Time Frame: pre, post, quarterly follow ups ] [ Designated as safety issue: No ]
  • physical and sedentary activity [ Time Frame: pre, post, quarterly follow ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body mass index [ Time Frame: pre, post, quarterly follow ups ] [ Designated as safety issue: No ]
  • participant satisfaction [ Time Frame: post intevention ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Multifamily group weight management intervention plus rewards for program attendance
Behavioral: Multifamily weight management intervention
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
Behavioral: Multifamily weight management intervention
8 week multifamily group weight management intervention incorporating behavioral health, nutrition, and activity disciplines.

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).

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863083

Locations
United States, Wisconsin
Medical College of Wisconsin/Children's Hosptial of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Health System, Inc.
Wisconsin Department of Health and Family Services
Investigators
Principal Investigator: Rachel Neff Greenley, PhD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Rachel Neff Greenley PhD/Principal Investigator, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00863083     History of Changes
Other Study ID Numbers: CHW 08/101
Study First Received: March 16, 2009
Last Updated: June 17, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
pediatric obesity
pediatric overweight
multi-family group weight management intervention
financial rewards

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014