- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00604981
Multisystemic Therapy (MST) for Obesity in African American Youth
January 29, 2008 updated by: Wayne State University
Adapting Multisystemic Therapy to Improve Food Choices and Health Outcomes in Obese African American Youth
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48335
- Wayne State University, Pediatric Prevention Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Multisystemic Therapy (MST)
|
MST is an intensive, family centered, community based treatment originally designed for use with adolescents presenting with serious mental health problems.
In this study, MST interventions are aimed at increasing adolescent and family adherence to dietary and exercise recommendations and targeting barriers within the family system, and the broader community systems within which the family is embedded (peers, schools, health care).
Decreasing caloric consumption consistent with recommended intake targets, increasing daily exercise and decreasing sedentary activity, are treatment focuses depending on whether the adolescent has difficulty with this aspect of weight management or not.
|
Active Comparator: 2
Shapedown
|
Shapedown, is a clinic-based, adolescent weight loss intervention.
Shapedown utilizes psycho educational, behavior, and family therapy techniques in a 10-week group intervention.
In order to match MST's length of intervention (6 months), three follow-up sessions are added at monthly intervals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight (lbs, BMI)
Time Frame: baseline, 7 months post treatment, 12 months post treatment
|
baseline, 7 months post treatment, 12 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
food choices
Time Frame: baseline, 7 months (post treatment), 12 months post treatment
|
baseline, 7 months (post treatment), 12 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
January 17, 2008
First Submitted That Met QC Criteria
January 29, 2008
First Posted (Estimate)
January 30, 2008
Study Record Updates
Last Update Posted (Estimate)
January 30, 2008
Last Update Submitted That Met QC Criteria
January 29, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 7-05-HFC-24
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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