The Healthy Lifestyle Study - Full Text View

Sponsored by:	Robert Wood Johnson Foundation
Information provided by:	Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:	NCT00119964

Purpose

The purpose of this study is to determine if an internet-based intervention will be effective in improving the lifestyle and weight of an obese employee population.

The intervention will last 12 months, and includes a weight tracker, a food intake tracker, an activity tracker, a calorie balance tool, an electronic discussion board, and electronic greeting cards.

Condition	Intervention	Phase
Obesity	Behavioral: internet based weight management tools	Phase I

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Weight Management for a Defined Employee Population Using an Interactive eHealth Portal

Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:

change in body mass index

Secondary Outcome Measures:

quality of life
blood pressure
hemoglobin A1c
total cholesterol
HDL cholesterol
HANDS depression score
wellness score on Summex Health Risk Appraisal
health care costs
unscheduled paid time off

Estimated Enrollment:	500
Study Start Date:	September 2004
Estimated Study Completion Date:	August 2007

Detailed Description:

The study will compare two groups over time, one of which will utilize the electronic tools, and one of which will not. The samples will be drawn from the employees of a metro-Milwaukee hospital, and will consist of obese (Body Mass Index, or BMI, of 30 or greater) employees only.

The primary outcome will be change in weight over the study time period as measured by the BMI. Secondary outcome measures will include quality of life, blood pressure, tests of blood sugar, cholesterol, presence of depression, lifestyle wellness score, health care costs and productivity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Obesity as defined by a BMI of 30 or greater
The ability to speak and understand english
Health insurance coverage through First Health (Aurora's employee insurance plan)
Not currently on another formal weight management program
Not currently taking any weight loss medications
Not currently disabled in such a way that participation would be precluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119964

Locations

United States, Wisconsin
Aurora Health Care
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

Alison Lux, MD

Aurora Health Care

More Information

Study ID Numbers:	51756
Study First Received:	July 6, 2005
Last Updated:	August 13, 2007
ClinicalTrials.gov Identifier:	NCT00119964
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Healthy

ClinicalTrials.gov processed this record on January 16, 2009