Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study
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|ClinicalTrials.gov Identifier: NCT01043718|
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : January 14, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: More-Intensive Behavioral: Less-Intensive||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Delivering an Evidence-Based Lifestyle Intervention Via the Internet: A Randomized Controlled Study|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||December 2012|
The online lifestyle intervention will include elements of a behavioral lifestyle program developed by the Diabetes Prevention Program. The program will assist individual participants with establishing appropriate weight loss goals, implementing dietary recommendations (including analysis of current diet), and defining exercise programs. The program curriculum provides standard information about healthy lifestyle, and behavioral techniques for integrating them into daily living. In each lesson, patients provide feedback about how they interpret the information, and ideas for integrating it into their lives.
|Active Comparator: Less-Intensive||
The participants will be provided with the information to access the online Diabetes Prevention Program (DPP) intervention materials. Following the original DPP trial, all DPP materials were placed online for the public to access. This group will receive a lifestyle counseling session and tools to facilitate their intervention.
- Change in body weight (kg) [ Time Frame: 6 months, 12 months, 18 months ]
- Percentage of body weight lost [ Time Frame: 6 months, 12 months, 18 months ]
- Change in blood pressure (mm Hg) [ Time Frame: 6 months, 12 months, 18 months ]
- Change in health-related quality of life as determined by the RAND-36 PCS or MCS [ Time Frame: 6 months, 12 months, 18 months ]
- Change in physical activity (steps per day) [ Time Frame: 6 months, 12 months, 18 months ]
- Change in dietary pattern [ Time Frame: 6 months, 12 months, 18 months ]
- Satisfaction with program [ Time Frame: 6 months, 12 months, 18 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043718
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Kathleen McTigue, MD MS MPH||University of Pittsburgh|