Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 5:37 AM
Study NCT ID:
NCT00123435
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2005-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Veterans Walk for Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2005-07-20', 'studyFirstSubmitQcDate': '2005-07-20', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': 'week 2, week 3, week 6, week 12, and week 24'}], 'secondaryOutcomes': [{'measure': 'Average daily activity level', 'timeFrame': 'week 2, week 12, and week24'}, {'measure': 'Quality of life and participant satisfaction', 'timeFrame': 'week 1, week 12, and week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavioral Research', 'Nutritional management', 'Physical activity', 'Prevention', 'Randomized control trial', 'walking program', 'Weight loss', 'World wide web'], 'conditions': ['Cardiovascular Diseases', 'Diabetes Mellitus', 'Hyperlipidemia', 'Hypertension', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '17521443', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nStudy 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:\n\n* nutritional counseling alone;\n* nutritional counseling with simple pedometer feedback; and\n* nutritional counseling, with both simple pedometer and enhanced pedometer (web-based) feedback.\n\nEach 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Is ambulatory and able to comfortably walk at least one block.\n* Has a body mass index (BMI) of 28 or greater.\n* Is not already regularly active (30 minutes a day, 5 days a week of moderate intensity physical activity).\n* Is in the contemplation or preparation stage of readiness to become more physically active.\n* Is willing to try a walking program.\n* Can communicate comfortably in English.\n\nExclusion Criteria:\n\n* Has attended a nutritional counseling session in the past 28 days.\n* May be at risk for adverse cardiovascular events with a walking program--specifically participants who:\n\n * have symptoms of cardiovascular disease (CVD) while walking;\n * have been told by a physician that walking might be dangerous; or\n * have a stress test scheduled in the next two months.'}, 'identificationModule': {'nctId': 'NCT00123435', 'acronym': 'VWH', 'briefTitle': 'Veterans Walk for Health Study', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Does Step Count Feedback Enhance Counseling for Weight Loss?', 'orgStudyIdInfo': {'id': 'D3358-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': '5-session nutritional counseling program', 'interventionNames': ['Behavioral: Nutritional counseling', 'Behavioral: Walking program']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': '5-session nutritional counseling program + simple pedometer feedback', 'interventionNames': ['Behavioral: Nutritional counseling', 'Behavioral: Walking program', 'Device: Simple pedometer']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3', 'description': '5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback', 'interventionNames': ['Behavioral: Nutritional counseling', 'Behavioral: Walking program', 'Device: Simple pedometer', 'Device: Enhanced pedometer']}], 'interventions': [{'name': 'Nutritional counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 1']}, {'name': 'Walking program', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 1']}, {'name': 'Nutritional counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 2']}, {'name': 'Walking program', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 2']}, {'name': 'Simple pedometer', 'type': 'DEVICE', 'description': 'Device to be worn during waking hours to give an objective measure of steps taken each day.', 'armGroupLabels': ['Arm 2']}, {'name': 'Nutritional counseling', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 3']}, {'name': 'Walking program', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Arm 3']}, {'name': 'Simple pedometer', 'type': 'DEVICE', 'description': 'Device to be worn during waking hours to give an objective measure of steps taken each day.', 'armGroupLabels': ['Arm 3']}, {'name': 'Enhanced pedometer', 'type': 'DEVICE', 'description': 'Simple pedometer with the addition of web-based feedback.', 'armGroupLabels': ['Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'VA Ann Arbor Healthcare System, Ann Arbor, MI', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Caroline R Richardson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}, {'name': 'Julie C Lowery, PhD MHSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, MI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}