Veterans Walk for Health Study (VWH)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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? |
- Weight loss [ Time Frame: week 2, week 3, week 6, week 12, and week 24 ] [ Designated as safety issue: No ]
- 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 |
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| United States, Michigan | |
| VA Ann Arbor Healthcare System | |
| Ann Arbor, Michigan, United States, 48113-0170 | |
| 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 May 19, 2013