Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Pittsburgh
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change in body weight (kg)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Hershey Medical Center and the University of Pittsburgh are doing a research study to help meet the needs of the adult population at risk for diabetes and heart disease. This study will provide a web-based program that aims to help participants to develop healthier eating habits, lose weight and become more physically active. The Internet-based materials will teach participants about healthy eating and physical activity and will ask them to incorporate the information they learn into their daily lives.
The purpose of this study is to evaluate the effectiveness of online lifestyle change programs to promote weight loss, healthy eating and physical activity patterns, in the interest of reducing risk for and adverse outcomes of type 2 diabetes (T2D) and cardiovascular disease (CVD).
Investigators
Kathleen McTigue
Assistant Professor
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 80 years old
- •Obese based on World Health Organization criteria (BMI\>30kg/m2)
- •Receiving primary care from and referred by a provider at one of the Internal Medicine clinics at Milton S. Hershey Medical Center in Hershey, PA
- •Able to understand and sign an informed consent document
- •Able to communicate with the investigator and understand the requirements of this study
- •Exclusion Criteria
- •Primary care provider determines that the individual is unable to safely undertake moderately intense unsupervised physical activity (the equivalent of 30 minutes of brisk walking)
- •Primary care provider determines that the individual has inadequate cognitive function to participate in either active intervention curricula
- •Women who are pregnant, who are planning to become pregnant in the next two years, or who become pregnant during the study
- •Women who are breastfeeding
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in body weight (kg)
Time Frame: 6 months, 12 months, 18 months
Secondary Outcomes
- Change in blood pressure (mm Hg)(6 months, 12 months, 18 months)
- Percentage of body weight lost(6 months, 12 months, 18 months)
- Change in health-related quality of life as determined by the RAND-36 PCS or MCS(6 months, 12 months, 18 months)
- Change in physical activity (steps per day)(6 months, 12 months, 18 months)
- Change in dietary pattern(6 months, 12 months, 18 months)
- Satisfaction with program(6 months, 12 months, 18 months)