Steps to Health: Targeting Obesity in the Health Care Workplace

Not Applicable

Completed

• Conditions: Overweight; Obese
• Interventions: Behavioral: Steps to Health; Behavioral: Steps to Health Plus!

• Registration Number: NCT01299051
• Lead Sponsor: Duke University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Primary Completion: 2014-10
• Status Verified: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 550

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steps to Health	Steps to Health	Steps to Health worksite weight management program at Duke.
Steps to Health Plus!	Steps to Health Plus!	Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.

Primary Outcome Measures

Name	Time	Method
Weight loss	~1-2 years post baseline	Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.

Secondary Outcome Measures

Name	Time	Method
Improvement in nutrition	~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.
Relative cost of different programs	~1-3 years post baseline	Determine the overall relative impact of STH+ and STH on net program costs.
Improvement in level of physical activity	~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.
Relative impact of the different programs	~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.

Trial Locations

Locations (1)

Duke University Dept. of Community and Family Medicine; 🇺🇸 Durham, North Carolina, United States