Clinical Trial: The Healthy Lifestyle Study

This study is currently recruiting patients.

Sponsored by: Robert Wood Johnson Foundation
Information provided by: Robert Wood Johnson Foundation

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
 Behavior: internet based weight management tools
Phase I

MedlinePlus related topics:  Obesity

Study Type: Interventional
Study Design: Educational/Counseling/Training, 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: 
Primary Outcomes: change in body mass index
Secondary Outcomes: 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
Expected Total Enrollment:  500

Study start: September 2004;  Expected completion: August 2006
Last follow-up: March 2005

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 above,  Genders Eligible for Study:  Both
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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00119964

Laura Paluch, BA      414.649.6763    laura.paluch@aurora.org

Wisconsin
      Aurora Health Care, Milwaukee,  Wisconsin,  several,  United States; Recruiting

Study chairs or principal investigators

Paul P Hartlaub, MD, MSPH,  Principal Investigator,  Aurora Health Care   

More Information

Study ID Numbers:  51756
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119964
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26



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