VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
NCT Number: NCT00123435
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.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Not applicable
Ann Arbor, Michigan, 48105, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 to be worn during waking hours to give an objective measure of steps taken each day.
Simple pedometer with the addition of web-based feedback.
Time frame: week 2, week 3, week 6, week 12, and week 24
Time frame: week 2, week 12, and week24
Time frame: week 1, week 12, and week 24
US Department of Veterans Affairs
Fed
Does Step Count Feedback Enhance Counseling for Weight Loss?
Acronym: VWH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02991534
Body Weight, Cardiovascular Diseases
Sepulveda, California, United States
View Trial DetailsNCT06966258
Behavior, Body Weight
Birmingham, Alabama, United States
View Trial DetailsNCT06461273
Behavior, Body Weight
Newark, New Jersey, United States
View Trial DetailsNCT06543706
Body Weight, Brain Diseases
Beijing, Beijing Municipality, China
View Trial Details