Condition(s) treated: Cardiovascular Diseases; Diabetes Mellitus; Obesity; Hypertension; Hyperlipidemia

Intervention: Nutritional counseling (Behavior); Enhanced and simple pedometer (Device); Walking program (Behavior)

Enrollment status: Recruiting. Expecting to enroll 50 people.

Sponsor: Department of Veterans Affairs

Principal investigator(s) or official(s):
Caroline Richardson, MD MA, Principal Investigator, Affiliation: HSR&D Center of Excellence, VA Medical Center, Ann Arbor

Overall contact:
Jan Adams-Watson, MHSA, Phone: 734-769-7100, Ext: 6205, Email: jan.adams-watson@med.va.gov

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.

Official title: Does Step Count Feedback Enhance Counselling for Weight Loss?

Study design: Interventional, Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Decrease in weight and increase in physical activity (as measured by accelerometer) at 6 months following enrollment in program

Secondary outcome: Improvement in health-related quality of life and participant satisfaction will be measured at 6 months following enrollment in program. Attendance at nutritional counseling visits will be measured over the 6 months of program participation.

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. 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.

Minimum eligible age: 18 Years. Eligible gender(s): Male.

Criteria:

Inclusion Criteria:

- Is newly referred from a VA physician for nutritional counseling and 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.

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:

* 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.

Jan Adams-Watson, MHSA, Phone: 734-769-7100, Ext: 6205, Email: jan.adams-watson@med.va.gov

Ann Arbor VA Medical Center, Ann Arbor, Michigan 48105, United States; Recruiting

Ann Arbor HSR&D Center of Excellence Web page

Start date: July 2005
End date: December 2008
Last updated: December 12, 2005