Steps to Health: Targeting Obesity in the Health Care Workplace

March 7, 2016 updated by: Duke University
The proposal of this study is to compare the effectiveness of two worksite weight management programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for participants in the study who agreed to be contacted for future research.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Steps to Health and Steps to Health Plus! aim to help Duke employees achieve weight loss and maintain healthy weights. We will be following participants in these programs over a two year period. These two groups will be compared with an observational comparison group of employees who meet eligibility criteria but do not take part in the randomized controlled trial. We will assess whether the two programs decrease obesity-related injuries in the workplace and estimate the net costs of the two programs relative to their effectiveness more broadly.

In the additional follow-up, we will be assessing factors that may be related to program success. This will include a survey as well as some focus group data.

Study Type

Interventional

Enrollment (Actual)

550

Phase

  • Not Applicable

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Dept. of Community and Family Medicine

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:

  • Completion of a Health Risk Assessment
  • BMI ≥ 30
  • Able to read and understand study materials which are presented in English
  • No plans to leave Duke in the next year
  • Enrolled in one of the Duke health plans
  • Not currently pregnant

Exclusion Criteria:

  • Enrolled in the other available individual intervention programs (hypertension, cholesterol or pre-diabetes)
  • Enrolling in one of the LFL weight management programs in order to qualify for bariatric surgery

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Steps to Health
Steps to Health worksite weight management program at Duke.
Behavioral: Steps to Health

Steps to Health (STH): The STH curriculum is a 12-month educational program targeting obese employees for healthy lifestyle changes for weight loss. The program includes:

  • Face-to-face visit with counselor during Month 1 to set specific health goals.
  • Telephone counseling at 6 and 12 months, coupled with biometric feedback sessions.
  • Monthly generic health education materials sent via e-mail.
  • Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments.
Other Names:
  • STH
Experimental: Steps to Health Plus!
Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.
Behavioral: Steps to Health Plus!

The STH+ intervention is an intensive 12-month behavioral intervention targeting obese employees. It is stage-based and works with the participant at his/her level of readiness to change using counseling based on motivational interviewing. STH+ includes:

  • Face-to-face visit with counselor at Month 1
  • Meeting with exercise physiologist in Month 2
  • Monthly counseling sessions (in-person in Months 3, 6, 9 and 12, others via telephone)
  • Meeting with exercise physiologist during Month 5
  • Quarterly biometric feedback (Months 3, 6, 9, and 12)
  • Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments.
Other Names:
  • STH+, PTC
No Intervention: Observational Comparison
Observational comparison group consisting of employees who are eligible for the study but do not take part will also be used in analyses (approximately 1500 subjects).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: ~1-2 years post baseline
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
~1-2 years post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in level of physical activity
Time Frame: ~1-2 years post baseline.
Determine whether employees participating in STH+ will experience greater improvements level or amount of physical activity than employees in STH.
~1-2 years post baseline.
Relative impact of the different programs
Time Frame: ~1-2 years post baseline
Determine the relative impact of STH+ and STH on 1) reduction in workplace injuries and associated costs, 2) health care utilization and health claim reimbursements, and 3) absenteeism and presenteeism.
~1-2 years post baseline
Relative cost of different programs
Time Frame: ~1-3 years post baseline
Determine the overall relative impact of STH+ and STH on net program costs.
~1-3 years post baseline
Improvement in nutrition
Time Frame: ~1-2 years post baseline
Determine whether employees participating in STH+ will experience greater improvements in diet, as measured by amount of calories consumed from fat and amount of fruits and vegetables consumed than employees in STH.
~1-2 years post baseline

Collaborators and Investigators

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

Sponsor

Duke University

Investigators

  • Principal Investigator: Truls Ostbye, MD, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 3, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00010727
  • R01HD06578 (Other Grant/Funding Number: National Institute of Occupational Safety and Health)

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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