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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00123435 |
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 |
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Cardiovascular Diseases Diabetes Mellitus Hyperlipidemia Hypertension Obesity |
Behavioral: Nutritional counseling Behavioral: Walking program Device: Simple pedometer Device: Enhanced pedometer |
| MedlinePlus related topics: | Diabetes High Blood Pressure Obesity Weight Control |
| Drug Information available for: | Ethanol |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Does Step Count Feedback Enhance Counseling for Weight Loss? |
| Enrollment: | 254 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2008 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Active Comparator
5-session nutritional counseling program
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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.
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2: Experimental
5-session nutritional counseling program + simple pedometer feedback
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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.
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3: Experimental
5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback
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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.
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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
May be at risk for adverse cardiovascular events with a walking program--specifically participants who:
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
| Responsible Party: | Department of Veterans Affairs ( Richardson, Caroline - Principal Investigator ) |
| Study ID Numbers: | D3358R |
| First Received: | July 20, 2005 |
| Last Updated: | October 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00123435 |
| Health Authority: | United States: Federal Government |
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