Steps to Health: Targeting Obesity in the Health Care Workplace
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|ClinicalTrials.gov Identifier: NCT01299051|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obese||Behavioral: Steps to Health Behavioral: Steps to Health Plus!||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||550 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Steps to Health: Targeting Obesity in the Health Care Workplace|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||March 2016|
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:
Other Name: 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:
Other Name: 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).
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299051
|United States, North Carolina|
|Duke University Dept. of Community and Family Medicine|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Truls Ostbye, MD, PHD||Duke University|