Clinical trial NCT00123435: Veterans Walk for Health Study
Official title: Does Step Count Feedback Enhance Counseling for Weight Loss?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Diabetes Mellitus
Hyperlipidemia
Hypertension
Obesity
Keywords: Behavioral Research
Nutritional management
Physical activity
Prevention
Randomized control trial
walking program
Weight loss
World wide web
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-22
Enrollment: 254
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 or who have responded to advertisements for the study. 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Weight loss
timeFrame: week 2, week 3, week 6, week 12, and week 24
Secondary outcomes:
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
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
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
References:
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.