PACE-iDP: An Intervention for Youth at Risk for Diabetes
2 other identifiers
interventional
101
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Feb 2006
Typical duration for not_applicable obesity
1 active site
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
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedAugust 16, 2012
August 1, 2012
3.2 years
December 13, 2006
August 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents.
baseline, 6 mo, 12 mo
Secondary Outcomes (3)
at 6 and 12 months,the impact of the PACEi-DP interventions on:metabolic and physiological manifestations of insulin resistance
6 mo, 12 mo
anthropometric measures including BMI at 6 months, waist to hip ratio at 6 and 12 months, percent body fat (DEXA) at 6 and 12 months,and
6 mo, 12 mo
behavioral measures of diet and physical activity.
6 mo, 12 mo
Study Arms (4)
usual care
NO INTERVENTIONUsual care arm receives standard physical activity, nutrition and weight loss information from their primary care provider. The study offers and pays for a series of weight management sessions provided by Rady's Children's Hospital and Health Center's Nutrition Dept.
Intervention - Web
EXPERIMENTALThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition.
Intervention - Group
EXPERIMENTALThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and has access to monthly group session with other teen and parent participants.
Intervention - Cell Phone
EXPERIMENTALThis group receives access to a program internet site with weekly challenges aimed at weight loss through increased physical activity and nutrition and are provided with cell phones to use during the program. The cell phone allows for the transfer of text messages from the study to the participant that are tailored to their health goals. In addition, self-monitoring and uploading capabilities to the program website are included.
Interventions
The cell phone arm receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
This group receives access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
The Group arm receives monthly face to face group sessions plus access to the website with weekly health ed materials and weekly case management via phone, mail, e-mail
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSD - CALIT2- Atkinson Hall
La Jolla, California, 92037, United States
Related Publications (3)
Kolodziejczyk JK, Gutzmer K, Wright SM, Arredondo EM, Hill L, Patrick K, Huang JS, Gottschalk M, Norman GJ. Influence of specific individual and environmental variables on the relationship between body mass index and health-related quality of life in overweight and obese adolescents. Qual Life Res. 2015 Jan;24(1):251-61. doi: 10.1007/s11136-014-0745-1. Epub 2014 Jul 1.
PMID: 24980678DERIVEDPatrick K, Norman GJ, Davila EP, Calfas KJ, Raab F, Gottschalk M, Sallis JF, Godbole S, Covin JR. Outcomes of a 12-month technology-based intervention to promote weight loss in adolescents at risk for type 2 diabetes. J Diabetes Sci Technol. 2013 May 1;7(3):759-70. doi: 10.1177/193229681300700322.
PMID: 23759410DERIVEDHuang JS, Gottschalk M, Norman GJ, Calfas KJ, Sallis JF, Patrick K. Compliance with behavioral guidelines for diet, physical activity and sedentary behaviors is related to insulin resistance among overweight and obese youth. BMC Res Notes. 2011 Feb 1;4:29. doi: 10.1186/1756-0500-4-29.
PMID: 21281521DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Patrick, MD, MS
UCSD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 13, 2006
First Posted
December 15, 2006
Study Start
February 1, 2006
Primary Completion
April 1, 2009
Study Completion
May 1, 2009
Last Updated
August 16, 2012
Record last verified: 2012-08