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Steps to Health: Targeting Obesity in the Health Care Workplace

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01299051
First received: February 3, 2011
Last updated: October 21, 2014
Last verified: October 2014

February 3, 2011
October 21, 2014
January 2011
October 2014   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: ~1-2 years post baseline ] [ Designated as safety issue: No ]
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
Weight loss [ Time Frame: ~1-4 years post baseline ] [ Designated as safety issue: No ]
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
Complete list of historical versions of study NCT01299051 on ClinicalTrials.gov Archive Site
  • Improvement in level of physical activity [ Time Frame: ~1-2 years post baseline. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Determine the overall relative impact of STH+ and STH on net program costs.
  • Improvement in nutrition [ Time Frame: ~1-2 years post baseline ] [ Designated as safety issue: No ]
    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.
  • Improvement in level of physical activity [ Time Frame: ~1-4 years post baseline. ] [ Designated as safety issue: No ]
    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: ~1-4 years post baseline ] [ Designated as safety issue: No ]
    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: ~1-4 years post baseline ] [ Designated as safety issue: No ]
    Determine the overall relative impact of STH+ and STH on net program costs.
  • Improvement in nutrition [ Time Frame: ~1-4 years post baseline ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
Steps to Health: Targeting Obesity in the Health Care Workplace
Steps to Health: Targeting Obesity in the Health Care Workplace

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+).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
  • Overweight
  • Obese
  • 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:

    • 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.
    Other Name: STH
  • 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:

    • 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.
    Other Name: STH+, PTC
  • Active Comparator: Steps to Health
    Steps to Health worksite weight management program at Duke.
    Intervention: Behavioral: Steps to Health
  • Experimental: Steps to Health Plus!
    Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.
    Intervention: Behavioral: Steps to Health Plus!
  • 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).
Østbye 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01299051
Pro00010727, R01HD06578
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Truls Ostbye, MD, PHD Duke University
Duke University
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP