Clinical trial NCT01299051: Steps to Health: Targeting Obesity in the Health Care Workplace
Official title: Steps to Health: Targeting Obesity in the Health Care Workplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Keywords: Weight Management
Employee Health
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: ~1-2 years post baseline
Secondary outcomes:
measure: Improvement in level of physical activity
timeFrame: ~1-2 years post baseline.
measure: Relative impact of the different programs
timeFrame: ~1-2 years post baseline
measure: Relative cost of different programs
timeFrame: ~1-3 years post baseline
measure: Improvement in nutrition
timeFrame: ~1-2 years post baseline
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Dept. of Community and Family Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Truls Ostbye, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ostbye T, Stroo M, Brouwer RJ, Peterson BL, Eisenstein EL, Fuemmeler BF, Joyner J, Gulley L, Dement JM. The steps to health employee weight management randomized control trial: rationale, design and baseline characteristics. Contemp Clin Trials. 2013 Jul;35(2):68-76. doi: 10.1016/j.cct.2013.04.007. Epub 2013 May 3.
citation: Ostbye T, Stroo M, Brouwer RJ, Peterson BL, Eisenstein EL, Fuemmeler BF, Joyner J, Gulley L, Dement JM. Steps to Health employee weight management randomized control trial: short-term follow-up results. J Occup Environ Med. 2015 Feb;57(2):188-95. doi: 10.1097/JOM.0000000000000335.
citation: Ostbye T, Stroo M, Eisenstein EL, Dement JM. The Effects of Two Workplace Weight Management Programs and Weight Loss on Health Care Utilization and Costs. J Occup Environ Med. 2016 Feb;58(2):162-9. doi: 10.1097/JOM.0000000000000586.