Veterans Walk for Health Study

NCT00123435 | Completed

• 1 other identifier: D3358-R
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Weight loss

  week 2, week 3, week 6, week 12, and week 24

Secondary Outcomes (2)

• Average daily activity level

  week 2, week 12, and week24

• Quality of life and participant satisfaction

  week 1, week 12, and week 24

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

5-session nutritional counseling program

Behavioral: Nutritional counseling; Behavioral: Walking program

Arm 2

EXPERIMENTAL

5-session nutritional counseling program + simple pedometer feedback

Behavioral: Nutritional counseling; Behavioral: Walking program; Device: Simple pedometer

Arm 3

EXPERIMENTAL

5-session nutritional counseling program + simple pedometer feedback + enhanced pedometer feedback web-based feedback

Behavioral: Nutritional counseling; Behavioral: Walking program; Device: Simple pedometer; Device: Enhanced pedometer

Interventions

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.

Arm 1

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.

Arm 1

Simple pedometer DEVICE

Device to be worn during waking hours to give an objective measure of steps taken each day.

Arm 2

Enhanced pedometer DEVICE

Simple pedometer with the addition of web-based feedback.

Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

• 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.

  PMID: 17521443 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Hyperlipidemias; Hypertension; Obesity; Motor Activity; Weight Loss

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2005
• First Posted: July 22, 2005
• Study Start: July 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2009
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (1)