Obesity Clinical Trial
— STANDOfficial title:
USC Center for Transdisciplinary Research on Energetics and Cancer or Obesity-Related Metabolic Disease Risk: Response to Exercise in Minority Youth
Verified date | March 2017 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in African American youth. Sixty overweight African American boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake), or 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar & soda, increased fiber & whole grain intake). The investigators will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Overweight (=85th BMI percentile) - African American: Children will initially be defined as African American if they and both parents and all 4 grandparents self identify as African American. Exclusion Criteria: - Diabetes: Children will not be eligible for participation if they have any diagnostic criteria for diabetes, including polyuria, polydipsia with or without unexplained weight loss, fasting plasma glucose >126 mg/dl, or a 2-hour plasma glucose >200 mg/dL during an OGTT using a dose of 1.75g glucose/kg BW (to a maximum of 75g). Children will also be excluded if they test positive for diabetes-related auto-antibodies, including ICA512 and GAD. Children testing positive for type 2 diabetes will be referred for treatment. Children with impaired glucose tolerance (fasting glucose >100 mg/dL or 2-hour glucose >140 mg/dl during an oral glucose tolerance test) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, poly-cystic ovarian syndrome) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria. - Weight loss or exercise program: currently involved with any weight loss or exercise program, or have been in the 6 months prior to participation - Use of medications: taking any medications known to influence body composition or insulin action/secretion (e.g. prednisone, ritalin, growth hormone) - Syndromes that influence body composition: diagnosed with syndromes or diseases that may influence body composition and fat distribution (e.g. Cushing syndrome, Down syndrome) |
Country | Name | City | State |
---|---|---|---|
United States | Veronica Atkins Lifestyle Intervention Laboratory | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | insulin sensitivity | post interventive (week 16) | ||
Secondary | adiposity | post intervention (week 16) |
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