Multisystemic Therapy (MST) for Obesity in African American Youth
| Tracking Information | |||||
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| First Received Date ICMJE | January 17, 2008 | ||||
| Last Updated Date | January 29, 2008 | ||||
| Start Date ICMJE | May 2005 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
weight (lbs, BMI) [ Time Frame: baseline, 7 months post treatment, 12 months post treatment ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00604981 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
food choices [ Time Frame: baseline, 7 months (post treatment), 12 months post treatment ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Multisystemic Therapy (MST) for Obesity in African American Youth | ||||
| Official Title ICMJE | Adapting Multisystemic Therapy to Improve Food Choices and Health Outcomes in Obese African American Youth | ||||
| Brief Summary | Despite the dramatic increase in obesity and Type II Diabetes in adolescents, documented effective treatments for obesity and the consequential prevention of Type II Diabetes are scarce. Modification of food and activity choices is the foundation of obesity treatment; however, adolescents may find it difficult to follow recommended diet and exercise programs. This study uses a home-based treatment, Multisystemic Therapy (MST), to target change within the individual, family and environmental contexts. Participants are 49 obese (BMI>95th percentile) African American adolescents (ages 12-17). 24 were randomized to receive the MST intervention and 25 were placed in Shapedown, a family group program. Families were recruited from the only university-affiliated medical center in Detroit, Michigan. Michigan's youth have higher rates of obesity, overweight, hypertension, and elevated cholesterol compared to the national average, and Detroit has the highest percentage of African Americans of any major city in the US. Families complete measurements at the start of the treatment, at the end of the treatment and one year after enrollment. We expect to find that youth in the MST group will show more weight loss and greater improvements in diet (e.g., caloric intake and exercise behaviors than will youth in Shapedown. These changes in food choices, activity levels, and weight are expected to remain after the end of treatment. This intervention is intended to provide immediate assistance to a vulnerable population disproportionately affected by obesity and its long-term health complications. |
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| Detailed Description | Despite the increase in pediatric obesity, controlled intervention trials among adolescents are rare and fail to address vital socio-ecological factors, particularly in minority youth. Modification of food and activity choices is the foundation of obesity treatment; however, adherence to these recommendations is a major barrier. We have adapted the home-based Multisystemic Therapy (MST) to successfully improve outcomes in urban adolescents with diabetes. The objective of the present study is to adapt MST to improve adherence to recommended food and activity choices and reduce BMI in obese (BMI>95th percentile) African American adolescents (ages 12-17). Additional aims are to determine if MST changes the individual, family, and environmental variables related to poor food choices (e.g., parental monitoring). Families are recruited from the only university-affiliated medical center in Detroit, Michigan. Michigan's youth have higher rates of obesity, overweight, hypertension, and elevated cholesterol compared to the national average. Detroit has the highest percentage of African Americans of any major city in the US. The design is a randomized controlled trial with 49 obese African American adolescents, 24 of whom receive MST and 25 of whom receive Shapedown, a family-based behavioral group intervention. Families complete a baseline data collection, a 7-month post-test coinciding with treatment completion, and a 12-month post-test. The primary aim of this project is Despite the increase in pediatric obesity, controlled intervention trials among adolescents are rare and fail to address vital socio-ecological factors, particularly in minority youth. Modification of food and activity choices is the foundation of obesity treatment; however, adherence to these recommendations is a major barrier. We have adapted the home-based Multisystemic Therapy (MST) to successfully improve outcomes in urban adolescents with diabetes. The objective of the present study is to adapt MST to improve adherence to recommended food and activity choices and reduce BMI in obese (BMI>95th percentile) African American adolescents (ages 12-16). Additional aims are to determine if MST changes the individual, family, and environmental variables related to poor food choices. Families will be recruited from the only university-affiliated medical center in Detroit, Michigan. Michigan's youth have higher rates of obesity, overweight, hypertension, and elevated cholesterol compared to the national average. Detroit has the highest percentage of African Americans of any major city in the US. The design is a randomized controlled trial with 49 obese African American adolescents, 24 of whom receive MST and 25 of whom receive a family-based behavioral group intervention. Families complete a baseline data collection, a 7-month post-test coinciding with treatment completion, and a 12-month post-test. If successful, this intervention will provide immediate assistance to a vulnerable population disproportionately affected by obesity and its long-term health complications. The project will also provide the foundation for a larger clinical trial as well as future interdisciplinary studies combining behavioral and medical interventions. If successful, this intervention will provide immediate assistance to a vulnerable population disproportionately affected by obesity and its long-term health complications. The project will also provide the foundation for a larger clinical trial as well as future interdisciplinary studies combining behavioral and medical interventions. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 49 | ||||
| Completion Date | November 2007 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00604981 | ||||
| Other Study ID Numbers ICMJE | 7-05-HFC-24 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Sylvie Naar-King, Ph.D., Associate Professor, Wayne State University | ||||
| Study Sponsor ICMJE | Wayne State University | ||||
| Collaborators ICMJE | American Diabetes Association | ||||
| Investigators ICMJE |
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| Information Provided By | Wayne State University | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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