ObesityNCT00604981
Multisystemic Therapy (MST) for Obesity in African American Youth
A study testing Multisystemic Therapy (MST) and Shapedown in people with Obesity, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- Multisystemic Therapy (MST) and Shapedown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Moderate or severe mental retardation or psychosis; AND
- Medical co morbidities that required treatment, including diabetes and hypertension.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University, Pediatric Prevention Research Center
Detroit, Michigan, 48335
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Multisystemic Therapy (MST), Shapedown
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisystemic Therapy (MST)Behavioural
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.
ShapedownBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Multisystemic Therapy (MST) Receives: Behavioral: Multisystemic Therapy (MST) |
| 2 | Active comparator | Shapedown Receives: Behavioral: Shapedown |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight (lbs, BMI)
Measured: baseline, 7 months post treatment, 12 months post treatment
Secondary outcomes (1)
food choices
Measured: baseline, 7 months (post treatment), 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Investigators
- Sylvie Naar-King, Ph.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604981
- Sponsor's protocol ID
- 7-05-HFC-24
- Status last verified
- Jan 2008
- First submitted
- 17 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Multisystemic Therapy to Improve Food Choices and Health Outcomes in Obese African American Youth
- ClinicalTrials.gov ID
- NCT00604981
- Acronym / sponsor ID
- 7-05-HFC-24
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- May 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Multisystemic Therapy (MST)Multisystemic Therapy (MST) |
| 2 | Active comparator | Behavioral: ShapedownShapedown |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnancy
- Moderate or severe mental retardation or psychosis; AND
- Medical co morbidities that required treatment, including diabetes and hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 1 |
| ShapedownShapedown, 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. | Behavioural | 2 |
Primary outcome
weight (lbs, BMI)
Time frame: baseline, 7 months post treatment, 12 months post treatment
1 secondary outcome
food choices
Time frame: baseline, 7 months (post treatment), 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvie Naar-King, Ph.D. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisystemic Therapy (MST) and Shapedown in people with Obesity, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (lbs, BMI) (time frame: baseline, 7 months post treatment, 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.