Trial Outcomes & Findings for Evaluation of the Remote Intervention for Diet and Exercise (RIDE) (NCT NCT00883350)
NCT ID: NCT00883350
Last Updated: 2024-12-03
Results Overview
weight loss calculated as a percentage of initial weight measured at baseline \[((weight at 12 weeks-weight at baseline)/weight at baseline) x 100\]
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-12-03
Participant Flow
Participant milestones
| Measure |
RIDE
Participants randomized to utilize the RIDE e-health application for the duration of the 12 week intervention.
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.
|
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., \[6\].
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Remote Intervention for Diet and Exercise (RIDE)
Baseline characteristics by cohort
| Measure |
RIDE
n=20 Participants
Participants randomized to utilize the RIDE e-health application for the duration of the 12 week intervention.
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.
|
Control
n=20 Participants
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., \[6\].
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
n=5 Participants
|
43.3 years
n=7 Participants
|
44.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksweight loss calculated as a percentage of initial weight measured at baseline \[((weight at 12 weeks-weight at baseline)/weight at baseline) x 100\]
Outcome measures
| Measure |
RIDE
n=19 Participants
Participants randomized to utilize the RIDE e-health application for the duration of the 12 week intervention.
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.
|
Control
n=19 Participants
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., \[6\].
|
|---|---|---|
|
Percent Change in Body Weight From Baseline to 12 Weeks
|
9.4 percent change
Standard Error 0.5
|
0.6 percent change
Standard Error 0.5
|
Adverse Events
RIDE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place