Clinical trial NCT00604981: Multisystemic Therapy (MST) for Obesity in African American Youth
Official title: Adapting Multisystemic Therapy to Improve Food Choices and Health Outcomes in Obese African American Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2008-01-30
Enrollment: 49
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Primary obesity as indicated by a BMI percentile \>=95th based on current height and weight using age and gender norms from the Centers for Disease Control and Prevention
* Self-identified as African American
* Between the ages of 12 years, 0 months and 17 years, 11 months and
* Residing in a home environment with a caregiver who was willing to participate in treatment.

Exclusion Criteria:

* Pregnancy
* Moderate or severe mental retardation or psychosis; AND
* Medical co morbidities that required treatment, including diabetes and hypertension.

Primary outcomes:
measure: weight (lbs, BMI)
timeFrame: baseline, 7 months post treatment, 12 months post treatment
Secondary outcomes:
measure: food choices
timeFrame: baseline, 7 months (post treatment), 12 months post treatment
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University, Pediatric Prevention Research Center
state: Michigan
Study officials:
affiliation: Wayne State University
name: Sylvie Naar-King, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: