OverweightNCT01299051
Steps to Health: Targeting Obesity in the Health Care Workplace
A study testing Steps to Health and Steps to Health Plus! in people with Overweight and Obese, run by Duke University at 1 site in United States.
Trial 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+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Steps to Health and Steps to Health Plus!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Dept. of Community and Family Medicine
Durham, North Carolina, 27710
About this study
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.
Read the 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
- Being tested
- Steps to Health, Steps to Health Plus!
- Keywords
- Weight Management, Employee Health
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steps to HealthBehavioural
Also called STH
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!Behavioural
Also called STH+, PTC
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.
| Study group | Role | What they receive |
|---|---|---|
| Steps to Health | Active comparator | Steps to Health worksite weight management program at Duke. Receives: Behavioral: Steps to Health |
| Steps to Health Plus! | Experimental | Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change. Receives: Behavioral: Steps to Health Plus! |
| Observational Comparison | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
Measured: ~1-2 years post baseline
Secondary outcomes (4)
Improvement in level of physical activity
Determine whether employees participating in STH+ will experience greater improvements level or amount of physical activity than employees in STH.
Measured: ~1-2 years post baseline.
Relative impact of the different programs
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.
Measured: ~1-2 years post baseline
Relative cost of different programs
Determine the overall relative impact of STH+ and STH on net program costs.
Measured: ~1-3 years post baseline
Improvement in nutrition
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.
Measured: ~1-2 years post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Truls Ostbye, MD, PHD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299051
- Sponsor's protocol ID
- Pro00010727
- Other IDs
- R01HD06578
- Status last verified
- Mar 2016
- First submitted
- 3 Feb 2011
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23648394Ostbye 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.
PubMed 25654520Ostbye 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.
PubMed 26849260
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Steps to Health: Targeting Obesity in the Health Care Workplace
- ClinicalTrials.gov ID
- NCT01299051
- Acronym / sponsor ID
- Pro00010727
- Conditions
- Overweight, Obese
- Keywords
- Weight Management, Employee Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Steps to Health | Active comparator | Behavioral: Steps to HealthSteps to Health worksite weight management program at Duke. |
| Steps to Health Plus! | Experimental | Behavioral: Steps to Health Plus!Steps to Health Plus! worksite weight management program at Duke. Also known as Pathways to Change. |
| Observational Comparison | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steps to HealthAlso: STHSteps 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. | Behavioural | Steps to Health |
| Steps to Health Plus!Also: STH+, PTCThe 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. | Behavioural | Steps to Health Plus! |
Primary outcome
Weight loss
Time frame: ~1-2 years post baseline
Determine whether employees participating in STH+ will lose significantly more body mass than participants in STH.
4 secondary outcomes
Improvement in level of physical activity
Time frame: ~1-2 years post baseline.
Relative impact of the different programs
Time frame: ~1-2 years post baseline
Relative cost of different programs
Time frame: ~1-3 years post baseline
Improvement in nutrition
Time frame: ~1-2 years post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Background: PubMed 23648394Ostbye 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.
- Results publication: PubMed 25654520Ostbye 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.
- Results publication: PubMed 26849260Ostbye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Truls Ostbye, MD, PHD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steps to Health and Steps to Health Plus! in people with Overweight and Obese, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: ~1-2 years post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01299051, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.