The Healthy Lifestyle Study

July 25, 2011 updated by: Robert Wood Johnson Foundation

Weight Management for a Defined Employee Population Using an Interactive eHealth Portal

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
change in body mass index

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Alison Lux, MD, Aurora Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 6, 2005

First Submitted That Met QC Criteria

July 6, 2005

First Posted (Estimate)

July 14, 2005

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 51756

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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