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Steps to Health: Targeting Obesity in the Health Care Workplace

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01299051
First received: February 3, 2011
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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+).


Condition Intervention
Overweight
Obese
 Behavioral: Steps to Health
Behavioral: Steps to Health Plus!

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Steps to Health: Targeting Obesity in the Health Care Workplace

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Weight loss [ Time Frame: ~1-3 years post baseline ] [ Designated as safety issue: No ]
    Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.


Secondary Outcome Measures:
  • Improvement in level of physical activity [ Time Frame: ~1-3 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: ~1-3 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: ~1-3 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.


Enrollment: 550
Study Start Date: January 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:

  • 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
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:

  • 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
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299051

Locations
United States, North Carolina
Duke University Dept. of Community and Family Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Truls Ostbye, MD, PHD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01299051     History of Changes
Other Study ID Numbers: Pro00010727, R01HD06578
Study First Received: February 3, 2011
Last Updated: February 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Weight Management
Employee Health

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013