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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | 5-session nutritional counseling program |
|
| Arm 2 | Experimental | 5-session nutritional counseling program + simple pedometer feedback |
|
| Arm 3 | Experimental | 5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | week 2, week 3, week 6, week 12, and week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily activity level | week 2, week 12, and week24 | |
| Quality of life and participant satisfaction | week 1, week 12, and week 24 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline R Richardson, MD | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Julie C Lowery, PhD MHSA | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17521443 | Result | 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. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| D006973 | Hypertension |
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Walking program | Behavioral | 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 counseling | Behavioral | 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 program | Behavioral | 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 pedometer | Device | Device to be worn during waking hours to give an objective measure of steps taken each day. |
|
| Nutritional counseling | Behavioral | 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 program | Behavioral | 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 pedometer | Device | Device to be worn during waking hours to give an objective measure of steps taken each day. |
|
| Enhanced pedometer | Device | Simple pedometer with the addition of web-based feedback. |
|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D014652 | Vascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |