Clinical Trials Directory

Trials / Completed

CompletedNCT00883350

Evaluation of the Remote Intervention for Diet and Exercise (RIDE)

Design and Evaluation of the Remote Intervention for Diet and Exercise (RIDE)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Pennington Biomedical Research Center · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

A large proportion of the adult population in the United States qualifies for weight loss treatment based on the NIH treatment recommendations, but traditional clinic-based weight loss treatments have a number of limitations. For example, access to healthcare facilities is limited among people living in rural communities and people of low socioeconomic status, yet a disproportionate number of these people would benefit from services. Internet-based weight loss interventions have been used to deliver services to these populations, but these "e-Health" interventions suffer from a number of limitations and produce only modest weight loss. The limitations associated with internet-based interventions include decreased use of the internet application over time; patients must logon to the internet to receive treatment recommendations, yet few patients regularly logon to the application and this negatively affects treatment outcome. An additional limitation is the quality of self-reported food intake, exercise, and body weight data that participants enter into the internet application or report to their online counselor. Self-reported data are associated with error and accurate data are needed to formulate effective treatment recommendations for participants. Lastly, most applications rely on asynchronous communications between the patient and the counselor, and patients do not always receive personalized treatment recommendations in a reasonable amount of time (1 to 3 days), which limits the extent to which the recommendations result in behavior change and weight loss. The purpose of the proposed pilot and feasibility project is to test the efficacy of the Remote Intervention for Diet and Exercise (RIDE) e-Health application at promoting weight loss compared to a control condition. The RIDE e-Health application addresses the limitations of internet-based interventions that are noted above. The application relies on novel technology to collect near real-time food intake, body weight, and exercise data from participants while they reside in their free-living environments. These data are transmitted to the researchers in near real-time: food intake data are collected and transmitted with camera and Bluetoothenabled cell phones using the Remote Food Photography method that was developed by this laboratory, body weight data is automatically transmitted daily from a bathroom scale using the same phones, and accelerometry is used to collect exercise data that is transmitted via the internet. These data are analyzed and personalized treatment recommendations are sent to the participant in a timely manner, e.g., every 1 to 3 days, using the cell phones. The RIDE e-Health application was developed based on learning and behavioral theory to maximize behavior change and weight loss. The findings of this study will have significant implications for the affordable delivery of effective weight management interventions to patients with limited access to health care.

Detailed description

The prevalence of overweight and obesity has increased significantly over the past four decades, resulting in 66% of the adult population in the United States (U.S.) being classified as overweight or obese (Wang, 2007). Moreover, there is an over-representation of overweight and obesity among rural and low socioeconomicstatus groups (Wang, 2007). Consequently, a large proportion of the adult population in the U.S. qualifies for weight loss treatment based on the NIH treatment recommendations (NHLBI, 1998). Nevertheless, traditional weight loss treatments have a number of limitations, including lifestyle change (diet, exercise, and behavior therapy), which is one of the first options for treating overweight and obesity. First, delivering clinical services to the number of individuals who qualify for treatment would overwhelm the healthcare system. Second, many people who qualify for and would benefit from treatment cannot obtain services due to financial limitations or geographic location. Third, lifestyle change requires a significant time-commitment on the part of the patient and a team of professionals, resulting in fairly costly treatment. Despite the cost, lifestyle change fails to consistently promote long-term weight loss maintenance and the amount of weight lost in the short-term frequently fails to meet patient expectations (Foster, 1997). Lastly, lifestyle change typically involves meeting with the patient regularly, e.g., fortnightly, and patients do not always receive timely feedback about modifying behaviors to achieve an energy deficit. This is a significant limitation since learning theory indicates that behavior change is fostered by receiving specific feedback that is temporally contiguous to the target behavior. Feedback that is delayed or unspecific is less effective at inducing behavior change (Schultz, 2006). The application of novel technology to health problems has improved some areas of health care. For example, telemedicine applications have been used to monitor the vital signs of victims of mass casualty disasters (Gao, 2005). Technology-based methodologies have also been applied to weight loss treatments in an effort to improve treatment efficacy and more affordably deliver services to individuals with limited health care access, such as people living in rural communities. To date, these "e-Health" applications have focused primarily on internet-based interventions, which have been found to produce only modest weight loss (Weinstein, 2006; Williamson, 2006). Our group has conducted many internet-based weight management studies (Williamson, 2006; Stewart, 2008; Williamson, 2008; Williamson, 2007) and we have identified limitations that negatively affect the efficacy of e-Health applications. First, patients must logon to the internet to report their progress and data (e.g., amount of food intake) and to receive treatment recommendations, yet few patients regularly logon to the internet application. Second, most e-Health applications rely on the participant to self-report food intake and exercise data, and these self-reported data are typically inaccurate (Schoeller, 1990). Consequently, the quality of the feedback that the participant receives is limited by the poor quality of the self-reported data. Third, no application has been able to: a) obtain accurate free-living food intake, exercise, and body weight data from participants in near real-time, b) evaluate these data as they are received, and c) provide specific feedback to participants in a reasonable amount of time (1 to 3 days). Based on learning theory, this ability would result in superior behavior change (Schultz, 2006) and subsequent weight loss. The purpose of the proposed pilot and feasibility study is to test the efficacy of the Remote Intervention for Diet and Exercise (RIDE) e-Health application at promoting weight loss. The RIDE e-Health application addresses the limitations of internet-based interventions noted above. The application relies on novel technology to collect near real-time food intake, body weight, and exercise data from participants while they reside in their free-living environments. These data are transmitted to the researchers in near real-time: food intake data are collected and transmitted with camera and Bluetooth-enabled cell phones, body weight data are automatically transmitted from a bathroom scale using the same phones, and accelerometry is used to collect exercise data that is transmitted via the internet. These data are analyzed and personalized treatment recommendations are sent to the participant via the cell phone in a timely manner, e.g., every 1 to 3 days.

Conditions

Interventions

TypeNameDescription
BEHAVIORALRIDE e-health applicationThe RIDE e-Health application utilizes the latest technology to obtain near real-time food intake, body weight, and exercise data from participants living in their natural environment. The application also provides personalized and timely feedback and treatment recommendations based on participants' data. The application relies on the Remote Food Photography Method (Martin, 2009), which was developed by our research team, to collect freeliving food intake data that is transmitted to the researchers in near realtime using a camera and Bluetooth-enabled cell phone. A scale is used to collect daily body weight data from participants and these data are automatically transmitted to the researchers via the same cell phone. The e-Health application collects exercise data from participants and these data are delivered to the researchers via the internet; personalized feedback and treatment recommendations are sent to the participant every 1 to 3 days via the cell phone.

Timeline

Start date
2009-05-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2009-04-17
Last updated
2024-12-03
Results posted
2024-12-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00883350. Inclusion in this directory is not an endorsement.