Steps to Health: Targeting Obesity in the Health Care Workplace
2 other identifiers
interventional
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 3, 2011
CompletedFirst Posted
Study publicly available on registry
February 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 8, 2016
March 1, 2016
3.8 years
February 3, 2011
March 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight loss
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
~1-2 years post baseline
Secondary Outcomes (4)
Improvement in level of physical activity
~1-2 years post baseline.
Relative impact of the different programs
~1-2 years post baseline
Relative cost of different programs
~1-3 years post baseline
Improvement in nutrition
~1-2 years post baseline
Study Arms (3)
Steps to Health
ACTIVE COMPARATORSteps to Health worksite weight management program at Duke.
Steps to Health Plus!
EXPERIMENTALSteps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.
Observational Comparison
NO INTERVENTIONObservational 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Dept. of Community and Family Medicine
Durham, North Carolina, 27710, United States
Related Publications (3)
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.
PMID: 23648394BACKGROUNDOstbye 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.
PMID: 25654520RESULTOstbye 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.
PMID: 26849260RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Truls Ostbye, MD, PHD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2011
First Posted
February 18, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
March 1, 2016
Last Updated
March 8, 2016
Record last verified: 2016-03