Steps to Health: Targeting Obesity in the Health Care Workplace

Study Overview
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Brief Summary
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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
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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.

Official Title
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Steps to Health: Targeting Obesity in the Health Care Workplace

Conditions
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Overweight, Obese

Intervention / Treatment
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* Behavioral: Steps to Health
* Behavioral: Steps to Health Plus!


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Steps to Health<br>Steps to Health worksite weight management program at Duke. | Behavioral: Steps to Health<br>* 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.<br>* Other names: STH;|
| Experimental: Steps to Health Plus!<br>Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change. | Behavioral: Steps to Health Plus!<br>* 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.<br>* Other names: STH+, PTC;|
| No Intervention: Observational Comparison<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 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 | 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 | 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 | Determine the overall relative impact of STH+ and STH on net program costs. |  1-3 years post baseline | 
| Improvement in nutrition | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Management, Employee Health