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Sponsored by: |
Penn State University |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00709501 |
The purpose of the study is to determine whether using a web-based weight loss website can help overweight individuals lose weight.
Condition | Intervention |
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Overweight Obesity |
Behavioral: Disseminating Effective Habits for Long-term Weight Loss |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 75 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants in the intervention condition are encouraged to access the Achieve Together website at least once each week. During each login, the following activities will occur:
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Behavioral: Disseminating Effective Habits for Long-term Weight Loss
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
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2: No Intervention
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be given a log where they can document weekly weight measurements.
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Behavioral: Disseminating Effective Habits for Long-term Weight Loss
Comparison of weight change among those participants in the weight loss intervention (immediate access to the weight loss website) and those participants in the control group (delayed access to the weight loss website).
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Overweight and obesity are serious threats to public health. Over the last 20 years, the percentage of overweight and obese Americans, as well as the rate of diabetes, have grown tremendously (Cowie, Rust et al. 2006).
Few individuals are successful at long-term weight loss. Long-term weight loss is an elusive, yet sought after goal for many Americans (2000). Fewer than 5% of adults are successful in maintaining a 20 pound weight loss for at least 2 years (Klem, Wing et al. 1997). While medications can be effective, they produce only small amounts of weight loss, carry a significant cost and appear to be effective only while being taken (2000). Surgery is an effective option, though the procedure has tremendous costs and potential complications (2000). This points to the need for innovative and effective treatments that help individuals over the longer-term.
Some, but not all, web-based treatments for weight loss have been shown to be effective. A recent study by Tate and colleagues showed that individuals who received counseling emails from a human or automated emails from a computer lost more weight than individuals who received neither(7.3 kg lost v. 4.9 kg and 2.6 kg, respectively) (Tate, Jackvony et al. 2006) (Tate, Jackvony et al. 2003). The feedback in the emails was based on diet and physical activity information that the individuals entered online. Dr. Harvey-Berino and colleagues has shown that social support delivered via the Internet can help weight loss efforts to the same degree as in person support (Harvey-Berino, Pintauro et al. 2004). Other studies have been mixed in their effects (Williamson, Walden et al. 2006) (Gold, Burke et al. 2007) (Wing, Tate et al. 2006), though there has generally been an effect from human feedback delivered via a computer. Other than the recent study by Tate and colleagues, no fully automated website has been effective at producing weight loss. It is our belief that fully automated systems are needed to meet the needs, in a cost-effective manner, of the 80 million overweight Americans who will need life-long help in losing weight and in maintaining their weight loss.
During an earlier phase of the study, 50 in-depth interviews were conducted with individuals who have been successful at losing weight and keeping it off. These individuals were asked specifically about which habits they use to maintain their weight loss, how these habits are implemented and how barriers to using these habits are overcome. These interviews were transcribed and the data entered into a website, to be used as part of the intervention to be tested in this clinical trial.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
History of:
Contact: Christopher N Sciamanna, M.D., MPH | 717-531-8161 | cns10@psu.edu |
Contact: Jolene L Esposito, B.S. | 717-531-0003 ext 287515 | jle224@psu.edu |
United States, Pennsylvania | |
Penn State College of Medicine General Clinical Research Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Christopher N Sciamanna, M.D., MPH | Penn State College of Medicine |
Responsible Party: | Penn State College of Medicine ( Christopher N. Sciamanna, M.D., MPH ) |
Study ID Numbers: | 28160 |
Study First Received: | July 1, 2008 |
Last Updated: | July 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00709501 |
Health Authority: | United States: Institutional Review Board |
weight loss obesity overweight |
Body Weight Signs and Symptoms Obesity Weight Loss |
Nutrition Disorders Overnutrition Overweight |