Steps to Health: Targeting Obesity in the Health Care Workplace

NCT ID: NCT01299051

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Steps to Health

Steps to Health worksite weight management program at Duke.

Group Type: ACTIVE_COMPARATOR

Steps to Health

Intervention Type: BEHAVIORAL

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.

Steps to Health Plus!

Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change.

Group Type: EXPERIMENTAL

Steps to Health Plus!

Intervention Type: BEHAVIORAL

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

STH; STH+, PTC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Truls Ostbye, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Dept. of Community and Family Medicine

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23648394 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25654520 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26849260 (View on PubMed)

Other Identifiers

R01HD06578

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00010727

Identifier Type: -

Identifier Source: org_study_id