Cardiovascular DiseasesVWHNCT00123435
Veterans Walk for Health Study
A study testing Nutritional counseling, Walking program and Simple pedometer in people with Cardiovascular Diseases and Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Hyperlipidemia
- What is being tested?
- Nutritional counseling, Walking program and Simple pedometer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
About this study
Official title: Does Step Count Feedback Enhance Counseling for Weight Loss?
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.
Read the 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.
- Being tested
- Nutritional counseling, Walking program, Simple pedometer, Enhanced pedometer
- Keywords
- Behavioral Research, Nutritional management, Physical activity, Prevention, Randomized control trial, walking program, Weight loss, World wide web
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Hyperlipidemias, Hypertension, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counselingBehavioural
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.
Walking programBehavioural
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.
Nutritional counselingBehavioural
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.
Walking programBehavioural
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.
Simple pedometerDevice
Device to be worn during waking hours to give an objective measure of steps taken each day.
Nutritional counselingBehavioural
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.
Walking programBehavioural
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.
Simple pedometerDevice
Device to be worn during waking hours to give an objective measure of steps taken each day.
Enhanced pedometerDevice
Simple pedometer with the addition of web-based feedback.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | 5-session nutritional counseling program Receives: Behavioral: Nutritional counseling; Behavioral: Walking program |
| Arm 2 | Experimental | 5-session nutritional counseling program + simple pedometer feedback Receives: Behavioral: Nutritional counseling; Behavioral: Walking program; Device: Simple pedometer |
| Arm 3 | Experimental | 5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback Receives: Behavioral: Nutritional counseling; Behavioral: Walking program; Device: Simple pedometer; Device: Enhanced pedometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: week 2, week 3, week 6, week 12, and week 24
Secondary outcomes (2)
Average daily activity level
Measured: week 2, week 12, and week24
Quality of life and participant satisfaction
Measured: week 1, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionNov 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Caroline R Richardson, MD, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MIJulie C Lowery, PhD MHSA, Principal investigator, VA Ann Arbor Healthcare System, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00123435
- Sponsor's protocol ID
- D3358-R
- Acronym
- VWH
- Status last verified
- Aug 2015
- First submitted
- 20 Jul 2005
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1186/1479-5868-4-20.
PubMed 17521443
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Step Count Feedback Enhance Counseling for Weight Loss?
- ClinicalTrials.gov ID
- NCT00123435
- Acronym / sponsor ID
- VWH / D3358-R
- Keywords
- Behavioral Research, Nutritional management, Physical activity, Prevention, Randomized control trial, walking program, Weight loss, World wide web
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jul 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Nutritional counseling, Behavioral: Walking program5-session nutritional counseling program |
| Arm 2 | Experimental | Behavioral: Nutritional counseling, Behavioral: Walking program, Device: Simple pedometer5-session nutritional counseling program + simple pedometer feedback |
| Arm 3 | Experimental | Behavioral: Nutritional counseling, Behavioral: Walking program, Device: Simple pedometer, Device: Enhanced pedometer5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional counselingThe 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. | Behavioural | Arm 1 |
| Walking programAs 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. | Behavioural | Arm 1 |
| Nutritional counselingThe 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. | Behavioural | Arm 2 |
| Walking programAs 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. | Behavioural | Arm 2 |
| Simple pedometerDevice to be worn during waking hours to give an objective measure of steps taken each day. | Device | Arm 2 |
| Nutritional counselingThe 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. | Behavioural | Arm 3 |
| Walking programAs 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. | Behavioural | Arm 3 |
| Simple pedometerDevice to be worn during waking hours to give an objective measure of steps taken each day. | Device | Arm 3 |
| Enhanced pedometerSimple pedometer with the addition of web-based feedback. | Device | Arm 3 |
Primary outcome
Weight loss
Time frame: week 2, week 3, week 6, week 12, and week 24
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Results publication: PubMed 17521443Goodrich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline R Richardson, MD principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
Julie C Lowery, PhD MHSA principal investigator
VA Ann Arbor Healthcare System, Ann Arbor, MI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional counseling, Walking program and Simple pedometer in people with Cardiovascular Diseases and Diabetes Mellitus, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: week 2, week 3, week 6, week 12, and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00123435, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.