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

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00883350
First received: April 15, 2009
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Overweight
Obesity
Behavioral: RIDE e-health application

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Design and Evaluation of the Remote Intervention for Diet and Exercise (RIDE)

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in body weight, measured as percent of baseline body weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIDE
Participants randomized to utilize the RIDE e-health application for the duration of the 12 week intervention.
Behavioral: RIDE e-health application
The 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.
No Intervention: Control
Participants assigned to the Health-Ed (control) group will receive health information via the cell phone throughout the 84-day study. We have generated numerous health information tips for other studies on a variety of topics, including stress management, the benefits of eating fruits and vegetables, etc. [6-9]. These lessons will be modified for delivery via cell phone. We have found that participants assigned to these health information control groups report being satisfied with the information and their assignment. Importantly, our data also indicate that such health information results in very little behavior change or weight loss, e.g., [6].

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  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) is > 25 kg/m2 and < 35 kg/m2.
  • Willing to use cell phones provided by the PBRC or personal cell phones to take pictures of foods during the study and to receive messages from study personnel.
  • Willing to wear an activity monitor on your shoe and to use the internet to send information as frequently as once daily.
  • Willing to weigh on a scale provided by the PBRC as frequently as once per day
  • Willing to accept random assignment to either the e-Health (RIDE group) or control group.
  • Weight stable, defined as no greater than 4.4 lbs. (2 kg) weight change over the previous 60 days.

Exclusion Criteria:

  • Diagnosed with a chronic disease that affects body weight, appetite, or metabolism, namely diabetes, cardiovascular disease, cancer, and thyroid diseases or conditions.
  • Currently in a weight loss program.
  • Unable to engage in moderate intensity exercise.
  • Unable to diet or exercise due to your medical history or current health status.
  • Current use of prescriptions or over-the-counter medications or herbal products that affect appetite, body weight, or metabolism (e.g., weight loss medications such as sibutramine, antipsychotic medications such as olanzapine, ephedrine, and diuretics).
  • Diagnosed with uncontrolled hypertension (high blood pressure), defined as systolic blood pressure >159 mmHg & diastolic blood pressure >99 mmHg.
  • For females, current pregnancy, or plans to become pregnant in the duration of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883350

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Corby K Martin, PhD Pennington Biomedical Research Center
  More Information

Publications:
Stewart, T., et al., Development of an internet/population-based weight management program for the U.S. Army. Journal of Diabetes Science and Technology, 2008. 2(1): p. 116-126.

Responsible Party: Corby K Martin, PhD, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00883350     History of Changes
Other Study ID Numbers: 28023, 1R03DK083533
Study First Received: April 15, 2009
Last Updated: January 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Body weight changes
Overweight
Obesity

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014