Veterans Walk for Health Study

Not Applicable

Completed

• Conditions: Hyperlipidemia; Obesity; Hypertension; Cardiovascular Diseases; Diabetes Mellitus
• Interventions: Behavioral: Nutritional counseling; Behavioral: Walking program; Device: Simple pedometer; Device: Enhanced pedometer

• Registration Number: NCT00123435
• Lead Sponsor: US Department of Veterans Affairs

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Primary Completion: 2007-11
• Study Completion: 2009-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 254

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Nutritional counseling	5-session nutritional counseling program
Arm 2	Nutritional counseling	5-session nutritional counseling program + simple pedometer feedback
Arm 2	Walking program	5-session nutritional counseling program + simple pedometer feedback
Arm 2	Simple pedometer	5-session nutritional counseling program + simple pedometer feedback
Arm 3	Nutritional counseling	5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
Arm 1	Walking program	5-session nutritional counseling program
Arm 3	Enhanced pedometer	5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
Arm 3	Walking program	5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
Arm 3	Simple pedometer	5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback

Primary Outcome Measures

Name	Time	Method
Weight loss	week 2, week 3, week 6, week 12, and week 24

Secondary Outcome Measures

Name	Time	Method
Average daily activity level	week 2, week 12, and week24
Quality of life and participant satisfaction	week 1, week 12, and week 24

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States