NCT00604981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2005

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
Last Updated

January 30, 2008

Status Verified

January 1, 2008

Enrollment Period

2.5 years

First QC Date

January 17, 2008

Last Update Submit

January 29, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • weight (lbs, BMI)

    baseline, 7 months post treatment, 12 months post treatment

Secondary Outcomes (1)

  • food choices

    baseline, 7 months (post treatment), 12 months post treatment

Study Arms (2)

1

EXPERIMENTAL

Multisystemic Therapy (MST)

Behavioral: Multisystemic Therapy (MST)

2

ACTIVE COMPARATOR

Shapedown

Behavioral: Shapedown

Interventions

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.

1
ShapedownBEHAVIORAL

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.

2

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University, Pediatric Prevention Research Center

Detroit, Michigan, 48335, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvie Naar-King, Ph.D.

    Wayne State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2008

First Posted

January 30, 2008

Study Start

May 1, 2005

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 30, 2008

Record last verified: 2008-01

Locations