Disseminating Effective Habits for Long-Term Weight Loss
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|ClinicalTrials.gov Identifier: NCT00709501|
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : October 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Disseminating Effective Habits for Long-term Weight Loss Behavioral: Achieve Together website||Not Applicable|
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 helps 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Disseminating Effective Habits for Long-Term Weight Loss|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||December 2010|
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:
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).
Behavioral: Achieve Together website
access to the Achieve Together website immediately (Arm 1) or delayed (Arm 2)
No Intervention: 2
Participants in the control condition will have to wait 12 weeks before accessing the Achieve Together website. These participants will be a given a log where they can document weekly weight measurements (this part did not happen).
- Body weight [ Time Frame: 3 months ]Weight will be measured using a calibrated, digital scale
- Blood Pressure Control [ Time Frame: 3-Months ]
- Physical Activity, using the International Physical Activity Questionnaire [ Time Frame: 3 months ]Results are still being analyzed
- Block 2005 FFQ for assessment of diet and physical activity [ Time Frame: 3 Months ]
- IWQOL-Lite, a validated, 31-item, self-report measure of obesity-specific [ Time Frame: 3 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): NCT00709501
|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|