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The Healthy Lifestyle Study

This study has been completed.
Sponsor:
Information provided by:
Robert Wood Johnson Foundation
ClinicalTrials.gov Identifier:
NCT00119964
First received: July 6, 2005
Last updated: July 25, 2011
Last verified: July 2011
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00119964     History of Changes
Other Study ID Numbers: 51756
Study First Received: July 6, 2005
Last Updated: July 25, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014