Status:
COMPLETED
PACE-iDP: An Intervention for Youth at Risk for Diabetes
Lead Sponsor:
University of California, San Diego
Conditions:
Obesity
Overweight
Eligibility:
All Genders
12-16 years
Phase:
NA
Brief Summary
This randomized control study (sponsored by the NIH, NIDDK) is aimed at reducing BMI in overweight adolescents at risk for the development of type 2 diabetes. The study will examine whether an integra...
Detailed Description
Type 2 Diabetes Mellitus (DM) is a common disease that plagues over 16 million adults in the United States (American Diabetes Association \[ADA\], 2002). Over the past decade, the number of adults dia...
Eligibility Criteria
Inclusion
- Criteria for participation in the study include:
- Being overweight (BMI \> 85th percentile for age and sex, weight for height \>85th percentile, or weight \>120% of ideal for height). In addition, at least half of the study participants will have a BMI \> 95th percentile for age and sex. Study participants will have a maximum body weight of 285 pounds.
- Adolescent subjects must also have at least two of the following risk factors:
- family history of type 2 diabetes in a first-or second-degree relative,
- race/ethnicity of American Indian, African-American, Hispanic, Asian/Pacific Islander, or
- signs of insulin resistance (acanthosis nigricans, hypertension, dyslipidemia, or polycystic ovarian syndrome).
- In addition, adolescent subjects must be able to read and speak English or Spanish, have access to the Internet at home, school, or work, be reachable at a telephone number, be willing to participate in monthly 90-minute group meetings, have plans to stay in the San Diego area for the one-year study period, and have an English or Spanish speaking parent/guardian also willing to participate in the study.
- Parental consent (obtained in parents primary language) and subject assent is also required.
- Participants must have a parent or guardian agree to enroll who is able to speak and read in English or Spanish, has ongoing access and uses the internet, and plans to reside in San Diego for the length of the study.
Exclusion
- Subjects will be excluded from participation if they have any of the following conditions:
- Diabetes
- Pregnancy
- Cardiovascular problem, musculoskeletal problem or any medical condition that would limit their ability to comply with physical activity or dietary recommendations.
- Patients in foster care will be ineligible due to difficulty in obtaining follow-up measures.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00412165
Start Date
February 1 2006
End Date
May 1 2009
Last Update
August 16 2012
Active Locations (1)
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1
UCSD - CALIT2- Atkinson Hall
La Jolla, California, United States, 92037