Veterans Walk for Health Study (VWH)

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00123435
First received: July 20, 2005
Last updated: August 21, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Diabetes Mellitus
Hyperlipidemia
Hypertension
Obesity
Behavioral: Nutritional counseling
Behavioral: Walking program
Device: Simple pedometer
Device: Enhanced pedometer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Does Step Count Feedback Enhance Counseling for Weight Loss?

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Weight loss [ Time Frame: week 2, week 3, week 6, week 12, and week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 254
Study Start Date: July 2005
Study Completion Date: June 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
5-session nutritional counseling program
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.
Experimental: 2
5-session nutritional counseling program + simple pedometer feedback
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.
Experimental: 3
5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123435

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Caroline R Richardson, MD VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Richardson, Caroline - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00123435     History of Changes
Other Study ID Numbers: D3358R
Study First Received: July 20, 2005
Last Updated: August 21, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Behavioral Research
Nutritional management
Physical activity
Prevention
Randomized control trial
walking program
Weight loss
World wide web

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hyperlipidemias
Hypertension
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014