NCT00409786

Brief Summary

Diabetes affects 18 million Americans and costs over $132 billion in both direct treatment and lost productivity per year. It is known that weight loss, improved diet and increased exercise can result in improvement in glucose, lipid, and blood pressure control in patients with diabetes and reduce the incidence of diabetes in individuals at high risk. Effective delivery of proven, comprehensive lifestyle programs is difficult because of associated high costs. The internet provides a venue to deliver these lifestyle programs to large numbers of individuals while decreasing the cost per person. HealthTrak, the University of Pittsburgh Medical Center (UPMC) patient portal, provides an ideal setting to test such a program. HealthTrak provides participants with access to individual medical information while facilitating electronic communication with their physicians. Portal enhancements will allow the delivery of a comprehensive lifestyle intervention aimed at weight loss, improved diet, and increased exercise, and provide the opportunity to communicate with experts regarding concerns. Through this project, we will evaluate the modification of a successful comprehensive lifestyle intervention for delivery through HealthTrak. We will enroll and follow 50 individuals with diabetes or at high risk for diabetes for 12 months and examine change in parameters including diet, weight, physical activity, hemoglobin A1C, glucose, blood pressure, and lipid profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Nov 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

April 22, 2011

Completed
Last Updated

April 22, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

December 7, 2006

Results QC Date

February 23, 2011

Last Update Submit

March 23, 2011

Conditions

Obesity

Keywords

ObesityDiabetesInternetObesity with high cardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Baseline and 1 year

Secondary Outcomes (6)

  • Blood Pressure

    1 year

  • Lipid

    1 year

  • A1C (if Applicable)

    1 year

  • Fat Consumption

    1 year

  • Health Related Quality of Life

    1 year

  • +1 more secondary outcomes

Interventions

Virtual Lifestyle Management (VLM)BEHAVIORAL

16 weekly lessons followed by monthly maintenance lessons

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight (BMI≥25) and one of the following:
  • Hypertension, Diabetes, glucose intolerance, dyslipidemia
  • Age 18-80
  • Agrees to participate in the Virtual Lifestyle Management (VLM) program and evaluation
  • Computer access to UPMC Health Trak
  • Regular access to a scale

You may not qualify if:

  • Pregnancy
  • Inability to participate in moderate exercise as determined by the primary care physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PMID: 11832527BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Kathleen McTigue
Organization
University of Pittsburgh
mctiguekm@upmc.edu
412-692-2940

Study Officials

  • Rachel Hess, MD, MSc

    University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

  • Kathleen McTigue, MD, MSc

    University of Pittsburgh Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 11, 2006

Study Start

November 1, 2006

Primary Completion

February 1, 2008

Study Completion

March 1, 2008

Last Updated

April 22, 2011

Results First Posted

April 22, 2011

Record last verified: 2011-03

Locations

US(1)