Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123435
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2005-07-20
Brief Title:
Veterans Walk for Health Study
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Does Step Count Feedback Enhance Counseling for Weight Loss
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VWH
Brief Summary:
The objective of this study is to determine whether a tailored web-based system for providing feedback on walking step-counts in combination with regular nutrition counseling can improve weight loss over nutrition counseling alone in patients with heart disease
Detailed Description:
Objective This proposal was developed at the request of and with input from the Research Council of the Department of Veterans Affairs VAs National Advisory Board for Nutrition and Food Services in an effort to address obesity a major health problem for VA patients The prevalence of obesity in the United States has been increasing at an alarming rate As a result obesity related chronic diseases such as diabetes are also increasing in prevalence While interventions that focus only on dietary changes can result in significant weight loss the lost weight is often rapidly regained Physical activity when added to a dietary weight loss program not only increases the initial weight loss but it also can play a critical role in preventing weight regain The primary objective of the proposed study is to test the efficacy of a low-cost innovative weight loss program targeting lifestyle physical activity and diet in individuals with cardiovascular risk factors or disease
Study Design and Methods In this 3 year multi-site randomized controlled trial the investigators will recruit overweight and obese veterans with cardiovascular disease risk factors or known cardiovascular disease who have been referred for nutritional counseling or who have responded to advertisements for the study Research participants will be randomized to one of three study groups
nutritional counseling alone
nutritional counseling with simple pedometer feedback and
nutritional counseling with both simple pedometer and enhanced pedometer web-based feedback
Each participant will have 5 visits with a dietitian in the course of 6 months Participants randomized to receive pedometer feedback will review objectively monitored step-count data during their nutritional counseling sessions and will use the data to set new step-count goals The primary outcome weight loss will be assessed at the sixth and final session at the end of the 6-month intervention Enhanced pedometers that can monitor step-counts throughout the day and upload time stamped step count data to a central computer will be used to monitor adherence to a walking program
Study Design and Methods In this 3 year multi-site randomized controlled trial the investigators will recruit overweight and obese veterans with cardiovascular disease risk factors or known cardiovascular disease who have been referred for nutritional counseling or who have responded to advertisements for the study Research participants will be randomized to one of three study groups
nutritional counseling alone
nutritional counseling with simple pedometer feedback and
nutritional counseling with both simple pedometer and enhanced pedometer web-based feedback
Each participant will have 5 visits with a dietitian in the course of 6 months Participants randomized to receive pedometer feedback will review objectively monitored step-count data during their nutritional counseling sessions and will use the data to set new step-count goals The primary outcome weight loss will be assessed at the sixth and final session at the end of the 6-month intervention Enhanced pedometers that can monitor step-counts throughout the day and upload time stamped step count data to a central computer will be used to monitor adherence to a walking program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None