Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Veterans Walk for Health Study (VWH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123435
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Tracking Information
First Submitted Date  ICMJE July 20, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date August 21, 2015
Study Start Date  ICMJE July 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
Weight loss [ Time Frame: week 2, week 3, week 6, week 12, and week 24 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
Decrease in weight and increase in physical activity (as measured by accelerometer) at 6 months following enrollment in program.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • Average daily activity level [ Time Frame: week 2, week 12, and week24 ]
  • Quality of life and participant satisfaction [ Time Frame: week 1, week 12, and week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Veterans Walk for Health Study
Official Title  ICMJE Does Step Count Feedback Enhance Counseling for Weight Loss?
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' (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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Diabetes Mellitus
  • Hyperlipidemia
  • Hypertension
  • Obesity
Intervention  ICMJE
  • Behavioral: Nutritional counseling
    The nutritional counseling is based on the six-session Medical Nutrition Therapy Protocol for Weight Management published by the American Dietetics Association. The categories include the following: a) Meal planning (food, hydration, fiber, alcohol), b) Food label reading, c) Recipe modification, d) Food preparation, e) Dining out and f) Physical activity.
  • Behavioral: Walking program
    As part of the discussion of physical activity, participants in the control group will be encouraged to walk and dietitians will discuss goal setting using timed walks instead of total daily step-counts at each of the control group sessions. As a general guideline, participants will be encouraged to increase their daily walking target by 5-10 minutes (control group with time goals) or to increase their average daily step counts by 10-25% (pedometer group with step count goals) following each of the nutritional counseling sessions.
  • Device: Simple pedometer
    Device to be worn during waking hours to give an objective measure of steps taken each day.
  • Device: Enhanced pedometer
    Simple pedometer with the addition of web-based feedback.
Study Arms  ICMJE
  • Active Comparator: Arm 1
    5-session nutritional counseling program
    Interventions:
    • Behavioral: Nutritional counseling
    • Behavioral: Walking program
  • Experimental: Arm 2
    5-session nutritional counseling program + simple pedometer feedback
    Interventions:
    • Behavioral: Nutritional counseling
    • Behavioral: Walking program
    • Device: Simple pedometer
  • Experimental: Arm 3
    5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
    Interventions:
    • Behavioral: Nutritional counseling
    • Behavioral: Walking program
    • Device: Simple pedometer
    • Device: Enhanced pedometer
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2008)
254
Original Enrollment  ICMJE
 (submitted: July 20, 2005)
50
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123435
Other Study ID Numbers  ICMJE D3358-R
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Caroline R Richardson, MD VA Ann Arbor Healthcare System, Ann Arbor, MI
Principal Investigator: Julie C Lowery, PhD MHSA VA Ann Arbor Healthcare System, Ann Arbor, MI
PRS Account VA Office of Research and Development
Verification Date August 2015

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