PACE-iDP: An Intervention for Youth at Risk for Diabetes

Completed · Not applicable

Conditions studied: Obesity, Overweight, Diabetes

In brief

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 integrated primary care, web and cell-phone-based intervention can produce initial and sustained improvements in anthropometric, behavioral, metabolic, and physiological outcomes in overweight adolescents. The primary goal is to reduce BMI (Body Mass Index)in overweight adolescents.

Key facts

Study ID

NCT00412165

Run by

University of California, San Diego

People needed

101

Starts

2006-02-01

Expected to finish

2009-05-01

Last updated by the study team

2012-08-16

Who can join

Age: 12 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD - CALIT2- Atkinson Hall — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.