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Veterans Walk for Health Study (VWH)

Primary Purpose

Cardiovascular Diseases, Diabetes Mellitus, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritional counseling
Walking program
Nutritional counseling
Walking program
Simple pedometer
Nutritional counseling
Walking program
Simple pedometer
Enhanced pedometer
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Behavioral Research, Nutritional management, Physical activity, Prevention, Randomized control trial, walking program, Weight loss, World wide web

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

5-session nutritional counseling program

5-session nutritional counseling program + simple pedometer feedback

5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

Average daily activity level
Quality of life and participant satisfaction

Full Information

First Posted
July 20, 2005
Last Updated
August 19, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00123435
Brief Title
Veterans Walk for Health Study
Acronym
VWH
Official Title
Does Step Count Feedback Enhance Counseling for Weight Loss?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Diabetes Mellitus, Hyperlipidemia, Hypertension, Obesity
Keywords
Behavioral Research, Nutritional management, Physical activity, Prevention, Randomized control trial, walking program, Weight loss, World wide web

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
5-session nutritional counseling program
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
5-session nutritional counseling program + simple pedometer feedback
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Simple pedometer
Intervention Description
Device to be worn during waking hours to give an objective measure of steps taken each day.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional counseling
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Simple pedometer
Intervention Description
Device to be worn during waking hours to give an objective measure of steps taken each day.
Intervention Type
Device
Intervention Name(s)
Enhanced pedometer
Intervention Description
Simple pedometer with the addition of web-based feedback.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
week 2, week 3, week 6, week 12, and week 24
Secondary Outcome Measure Information:
Title
Average daily activity level
Time Frame
week 2, week 12, and week24
Title
Quality of life and participant satisfaction
Time Frame
week 1, week 12, and week 24

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline R Richardson, MD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julie C Lowery, PhD MHSA
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17521443
Citation
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. doi: 10.1186/1479-5868-4-20.
Results Reference
result

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Veterans Walk for Health Study

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