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Veterans Walk for Health Study (VWH)
This study has been completed.
Study NCT00123435   Information provided by Department of Veterans Affairs
First Received: July 20, 2005   Last Updated: August 21, 2009   History of Changes

July 20, 2005
August 21, 2009
July 2005
November 2007   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: week 2, week 3, week 6, week 12, and week 24 ] [ Designated as safety issue: No ]
Decrease in weight and increase in physical activity (as measured by accelerometer) at 6 months following enrollment in program.
Complete list of historical versions of study NCT00123435 on ClinicalTrials.gov Archive Site
  • Average daily activity level [ Time Frame: week 2, week 12, and week24 ] [ Designated as safety issue: No ]
  • Quality of life and participant satisfaction [ Time Frame: week 1, week 12, and week 24 ] [ Designated as safety issue: No ]
Improvement in health-related quality of life and participant satisfaction will be measured at 6 months following enrollment in program. Attendance at nutritional counseling visits will be measured over the 6 months of program participation.
 
Veterans Walk for Health Study
Does Step Count Feedback Enhance Counseling for Weight Loss?

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.

Objective: This proposal was developed at the request of, and with input from, the Research Council of the Department of Veterans Affairs' (VA's) 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.

 
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Hyperlipidemia
  • Hypertension
  • Obesity
  • Behavioral: Nutritional counseling
  • Behavioral: Walking program
  • Device: Simple pedometer
  • Device: Enhanced pedometer
  • Active Comparator: 5-session nutritional counseling program
  • Experimental: 5-session nutritional counseling program + simple pedometer feedback
  • Experimental: 5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
Goodrich DE, Larkin AR, Lowery JC, Holleman RG, Richardson CR. Adverse events among high-risk participants in a home-based walking study: a descriptive study. Int J Behav Nutr Phys Act. 2007 May 23;4:20.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
254
June 2009
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Is newly referred from a VA physician for nutritional counseling or has responded to an advertisement for the study - Has one of the following diagnoses: diabetes, coronary artery disease, hypercholesterolemia, hypertension, obesity.
  • Is ambulatory and able to comfortably walk at least one block.
  • Has a body mass index (BMI) of 28 or greater.
  • Is not already regularly active (30 minutes a day, 5 days a week of moderate intensity physical activity).
  • Is in the contemplation or preparation stage of readiness to become more physically active.
  • Is willing to try a walking program.
  • Can communicate comfortably in English.

Exclusion Criteria:

  • Has attended a nutritional counseling session in the past 28 days.
  • May be at risk for adverse cardiovascular events with a walking program--specifically participants who:

    • have symptoms of cardiovascular disease (CVD) while walking;
    • have been told by a physician that walking might be dangerous; or
    • have a stress test scheduled in the next two months.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00123435
Richardson, Caroline - Principal Investigator, Department of Veterans Affairs
D3358R
Department of Veterans Affairs
 
Principal Investigator: Caroline R Richardson, MD VA Ann Arbor Healthcare System
Department of Veterans Affairs
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP