ObesityWHEEL-PilotNCT02348983
Weight Loss Intervention in Long-Haul Truck Drivers: A Pilot Study
A study testing Health Coaching via Telephone in people with Obesity, run by University of Utah at 1 site in United States.
Trial summary
Being obese can be a risk factor for many health problems, including high cholesterol, high blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to our economy, face challenges that put them at increased likelihood of being obese. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Health Coaching via Telephone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2014
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women will be included as they are represented in this population, although, the investigators expect, at rates that are less than the overall population. This is a convenience sample, thus there will not be attempts to over or under represent genders. The individualization of the interventions increases the likelihood of success of the intervention with both men and women.
- The investigators will include minorities when possible. This is a convenience sample, so there will not be attempts to either over or under represent any racial or ethnic group.
- Commercial truck drivers must be 21 to drive interstate routes. Therefore, children, including those 18-20 years old, will not be included.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Being obese can be a risk factor for many health problems, including high cholesterol, high blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to our economy, face challenges that put them at increased likelihood of being obese. The investigators want to come up with a program to help drivers get to a healthy weight and stay there.
The WHEEL pilot study is a 12 week weight loss intervention in long-haul commercial truck drivers. The study involves two visits to the University of Utah's Rocky Mountain Center for Occupational and Environmental Health, one at the start of the study and a second one at the end of the study. Both visits include a general health history questionnaire, a 24-hour diet recall questionnaire, anthropometric measurements, as well as an assessment of blood pressure, hemoglobin A1c, and a cholesterol and lipid panel. Each truck driver is assigned a health coach who helps the driver create and achieve three health goals.
Read more
The health coach works with the driver to set individualized goals specific to weight loss, and contacts the driver weekly to check in and tweak goals as needed.
Drivers are also compensated for their participation in the study and get to keep all of the intervention materials that the investigators give them. All that the researchers ask is that they try their best to have a healthier lifestyle and give us feedback on what they liked and didn't like in the study.
Read the detailed description
The investigators recruited 13 truckers based in Utah's Wasatch Front (population 2.2 Million) who expressed interest in participating in a weight loss intervention when they participated in the cross-sectional truck driver study (current enrollment, n= 817 truckers). Other options the investigators may pursue to maintain enrollment include enrolling participants directly through local trucking companies. Participants will be screened for eligibility based on
- Age > 21
- BMI > 30 kg/m2
- No reported unstable chronic disease
Interstate truckers are required to be at least 21 years old. Participants will not be enrolled in the intervention until they complete the physical assessment component of the baseline visit that includes blood pressure, lipids, and HbA1c. Individuals who do not meet the established medical guidelines and regulations of the FMCSA will be excluded. Those individuals will be advised to follow-up for care with their personal physicians, and/or will be referred to a primary care clinic.
Health coaches will have at least weekly contact with participants to discuss individual goals and behavior change. Motivational messages will be delivered in addition to weekly content via text messages and/or emails. Research suggests that individuals who begin losing weight quickly are more successful at weight loss and maintaining loss, therefore, after 3 weeks individuals who have not lost at least 3 pounds will receive additional contacts with health coaches to address slow rate of weight loss. Individual Competitions surrounding successful healthy behaviors of Truckers will be conducted every other week. Winning behaviors will be shared with other participants by email, text, phone calls, blogs and/or other distance friendly format to both engage drivers and model successful peer behaviors.
This is a study of weight loss intervention for long-haul commercial truck drivers who face unusual challenges to a healthy lifestyle while working. Participants (n=13) will be long-haul commercial truck drivers with a BMI over 30 kg/m2. Due to licensing issues, all interstate truck drivers are required to be at least 21 years old (US DOT, FMCSA), and thus proposed study participants will be at least 21 years old.
The investigators are aware that there are some intrastate truck drivers who may be under age 21, however they are a much smaller and different population. By definition they are not long-haul drivers, tend to have more job instability, have a different occupational environment that is relevant to this study (e.g., sleep at home), and thus are a different population that this research does not target. Thus, this study has sound rationale for not including children ages 18-20.
The sampling will be convenient. Participants will be recruited using email, postal mail and opportunities for personal contact that are identified through the Utah Trucking Association website, newsletter, at truck stops, and at Commercial Truck Driver meetings. The investigators will inquire for current interest among subjects from our current cross sectional study who indicated interest in a follow-up study.
Participants will be screened for approximate BMI, and medical history prior to recruitment. Participants under current treatment for cancer will be excluded. Participants with significant medical issues (such as unstable blood pressure, diabetes mellitus) will be asked to provide a medical release from their physician prior to participation. Participants currently in treatment for cancer will be excluded. In addition participants will not be enrolled until they have completed the physical assessment component of the study with blood pressure below 159/99 mm Hg (stage 2 hypertension), HbA1c below 10.0%, and total cholesterol below 300 mg/dL. If participants do not meet these standards a letter of permission to participate from a physician will be required. Participants will be referred to their personal physician or the primary care clinic at the University of Utah Redwood Health Center if they do not have a personal physician to obtain such permission.
Study visits will take place in the Occupational Medicine conference room at the University of Utah Redwood Health Center where Drs. Eric Wood practice, to gather demographic data, medical history, reported physical activity, occupational health outcomes (slips trips and falls) and psychosocial factors, self-efficacy, sleepiness scale, job satisfaction and measure blood lipids, hemoglobin A1c and HsCRP, and body weight and circumferences at baseline and 12 weeks for all participants t. Participants will weigh themselves weekly using a scale provided by the study and will report weekly weight to health coaches using a scale provided via telephone, text, or email. Participants will have at least weekly contact with research staff (health coaches) regarding the intervention in the first 12 weeks of WHEEL. Contact will continue bi-weekly after the first 12 weeks of WHEEL with a goal of continued weight loss or weight loss maintenance.
All participants will receive the weight loss intervention. Participants will be monitored closely for weight loss success in the first 3 weeks of the intervention. If weight loss is not at least 3 pounds, then health coaches will double their efforts with these participants as it is known that early success is associated with better long-term success.
The investigators will obtain information on questionnaires, asking a person's birth date, but only record a person's age in tenths of a year. The investigators will measure height, weight, waist, hip, chest, neck circumferences, blood pressure, heart rate, take a finger-stick to measure fasting glucose, hemoglobin A1c, highly sensitive C-Reactive Protein, and blood lipids using point of service analysis and perform a urinalysis. No blood specimens will be stored.
Measurements and questionnaires will be completed in the Occupational Medicine conference room at the University of Utah Redwood Health Center in Salt Lake City. This clinic is conveniently located around the corner from a large truck stop, and close to both I-80 and I-15, the two main interstates in Salt Lake City. The clinic has ample truck-friendly parking. The investigators have obtained letters of support from The Utah Trucking Association. Data will be recorded on laptop computers that are encrypted. Consent forms will be transported to the University of Utah for storage in locked cabinets.
- Conditions
- Obesity
- Being tested
- Health Coaching via Telephone
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Coaching via TelephoneBehavioural
Health coaching arm to assess feasibility of intervention among truck driving population. Coaching will be weekly with emphasis on both diet and physical activity. No medication or treatment devices are administered.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Health coaching arm to assess feasibility of intervention among truck driving population. Coaching will be weekly with emphasis on both diet and physical activity. No medication or treatment devices are administered. Receives: Behavioral: Health Coaching via Telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Weight Loss from baseline to the end of the study
Difference in measured weight from baseline to the end of the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Thiese, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348983
- Sponsor's protocol ID
- MAP-ERC 5T42OH009229-06 Pilot
- Acronym
- WHEEL-Pilot
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Thiese MS, Effiong AC, Ott U, Passey DG, Arnold ZC, Ronna BB, Muthe PA, Wood EM, Murtaugh MA. A Clinical Trial on Weight Loss among Truck Drivers. Int J Occup Environ Med. 2015 Apr;6(2):104-12. doi: 10.15171/ijoem.2015.551.
PubMed 25890604
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Intervention in Long-Haul Truck Drivers: A Pilot Study
- ClinicalTrials.gov ID
- NCT02348983
- Acronym / sponsor ID
- WHEEL-Pilot / MAP-ERC 5T42OH009229-06 Pilot
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jan 2015 (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.
Being obese can be a risk factor for many health problems, including high cholesterol, high blood pressure, low back pain, heart attacks and some cancers. Truckers, who are integral to our economy, face challenges that put them at increased likelihood of being obese. The investigators want to come up with a program to help drivers get to a healthy weight and stay there.
The WHEEL pilot study is a 12 week weight loss intervention in long-haul commercial truck drivers. The study involves two visits to the University of Utah's Rocky Mountain Center for Occupational and Environmental Health, one at the start of the study and a second one at the end of the study. Both visits include a general health history questionnaire, a 24-hour diet recall questionnaire, anthropometric measurements, as well as an assessment of blood pressure, hemoglobin A1c, and a cholesterol and lipid panel. Each truck driver is assigned a health coach who helps the driver create and achieve three health goals.
The health coach works with the driver to set individualized goals specific to weight loss, and contacts the driver weekly to check in and tweak goals as needed.
Drivers are also compensated for their participation in the study and get to keep all of the intervention materials that the investigators give them. All that the researchers ask is that they try their best to have a healthier lifestyle and give us feedback on what they liked and didn't like in the study.
Detailed description
The investigators recruited 13 truckers based in Utah's Wasatch Front (population 2.2 Million) who expressed interest in participating in a weight loss intervention when they participated in the cross-sectional truck driver study (current enrollment, n= 817 truckers). Other options the investigators may pursue to maintain enrollment include enrolling participants directly through local trucking companies. Participants will be screened for eligibility based on
- Age > 21
- BMI > 30 kg/m2
- No reported unstable chronic disease
Interstate truckers are required to be at least 21 years old. Participants will not be enrolled in the intervention until they complete the physical assessment component of the baseline visit that includes blood pressure, lipids, and HbA1c. Individuals who do not meet the established medical guidelines and regulations of the FMCSA will be excluded. Those individuals will be advised to follow-up for care with their personal physicians, and/or will be referred to a primary care clinic.
Health coaches will have at least weekly contact with participants to discuss individual goals and behavior change. Motivational messages will be delivered in addition to weekly content via text messages and/or emails. Research suggests that individuals who begin losing weight quickly are more successful at weight loss and maintaining loss, therefore, after 3 weeks individuals who have not lost at least 3 pounds will receive additional contacts with health coaches to address slow rate of weight loss. Individual Competitions surrounding successful healthy behaviors of Truckers will be conducted every other week. Winning behaviors will be shared with other participants by email, text, phone calls, blogs and/or other distance friendly format to both engage drivers and model successful peer behaviors.
This is a study of weight loss intervention for long-haul commercial truck drivers who face unusual challenges to a healthy lifestyle while working. Participants (n=13) will be long-haul commercial truck drivers with a BMI over 30 kg/m2. Due to licensing issues, all interstate truck drivers are required to be at least 21 years old (US DOT, FMCSA), and thus proposed study participants will be at least 21 years old.
The investigators are aware that there are some intrastate truck drivers who may be under age 21, however they are a much smaller and different population. By definition they are not long-haul drivers, tend to have more job instability, have a different occupational environment that is relevant to this study (e.g., sleep at home), and thus are a different population that this research does not target. Thus, this study has sound rationale for not including children ages 18-20.
The sampling will be convenient. Participants will be recruited using email, postal mail and opportunities for personal contact that are identified through the Utah Trucking Association website, newsletter, at truck stops, and at Commercial Truck Driver meetings. The investigators will inquire for current interest among subjects from our current cross sectional study who indicated interest in a follow-up study.
Participants will be screened for approximate BMI, and medical history prior to recruitment. Participants under current treatment for cancer will be excluded. Participants with significant medical issues (such as unstable blood pressure, diabetes mellitus) will be asked to provide a medical release from their physician prior to participation. Participants currently in treatment for cancer will be excluded. In addition participants will not be enrolled until they have completed the physical assessment component of the study with blood pressure below 159/99 mm Hg (stage 2 hypertension), HbA1c below 10.0%, and total cholesterol below 300 mg/dL. If participants do not meet these standards a letter of permission to participate from a physician will be required. Participants will be referred to their personal physician or the primary care clinic at the University of Utah Redwood Health Center if they do not have a personal physician to obtain such permission.
Study visits will take place in the Occupational Medicine conference room at the University of Utah Redwood Health Center where Drs. Eric Wood practice, to gather demographic data, medical history, reported physical activity, occupational health outcomes (slips trips and falls) and psychosocial factors, self-efficacy, sleepiness scale, job satisfaction and measure blood lipids, hemoglobin A1c and HsCRP, and body weight and circumferences at baseline and 12 weeks for all participants t. Participants will weigh themselves weekly using a scale provided by the study and will report weekly weight to health coaches using a scale provided via telephone, text, or email. Participants will have at least weekly contact with research staff (health coaches) regarding the intervention in the first 12 weeks of WHEEL. Contact will continue bi-weekly after the first 12 weeks of WHEEL with a goal of continued weight loss or weight loss maintenance.
All participants will receive the weight loss intervention. Participants will be monitored closely for weight loss success in the first 3 weeks of the intervention. If weight loss is not at least 3 pounds, then health coaches will double their efforts with these participants as it is known that early success is associated with better long-term success.
The investigators will obtain information on questionnaires, asking a person's birth date, but only record a person's age in tenths of a year. The investigators will measure height, weight, waist, hip, chest, neck circumferences, blood pressure, heart rate, take a finger-stick to measure fasting glucose, hemoglobin A1c, highly sensitive C-Reactive Protein, and blood lipids using point of service analysis and perform a urinalysis. No blood specimens will be stored.
Measurements and questionnaires will be completed in the Occupational Medicine conference room at the University of Utah Redwood Health Center in Salt Lake City. This clinic is conveniently located around the corner from a large truck stop, and close to both I-80 and I-15, the two main interstates in Salt Lake City. The clinic has ample truck-friendly parking. The investigators have obtained letters of support from The Utah Trucking Association. Data will be recorded on laptop computers that are encrypted. Consent forms will be transported to the University of Utah for storage in locked cabinets.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Behavioral: Health Coaching via TelephoneHealth coaching arm to assess feasibility of intervention among truck driving population. Coaching will be weekly with emphasis on both diet and physical activity. No medication or treatment devices are administered. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women will be included as they are represented in this population, although, the investigators expect, at rates that are less than the overall population. This is a convenience sample, thus there will not be attempts to over or under represent genders. The individualization of the interventions increases the likelihood of success of the intervention with both men and women.
- The investigators will include minorities when possible. This is a convenience sample, so there will not be attempts to either over or under represent any racial or ethnic group.
- Commercial truck drivers must be 21 to drive interstate routes. Therefore, children, including those 18-20 years old, will not be included.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health Coaching via TelephoneHealth coaching arm to assess feasibility of intervention among truck driving population. Coaching will be weekly with emphasis on both diet and physical activity. No medication or treatment devices are administered. | Behavioural | Interventional Arm |
Primary outcome
Measured Weight Loss from baseline to the end of the study
Time frame: 12 weeks
Difference in measured weight from baseline to the end of the study.
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 30 Jan 2015.
- Derived from this study: PubMed 25890604Thiese MS, Effiong AC, Ott U, Passey DG, Arnold ZC, Ronna BB, Muthe PA, Wood EM, Murtaugh MA. A Clinical Trial on Weight Loss among Truck Drivers. Int J Occup Environ Med. 2015 Apr;6(2):104-12. doi: 10.15171/ijoem.2015.551.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching via Telephone in people with Obesity, run by University of Utah 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 3 inclusion and 0 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 30 Jan 2015. 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?
Measured Weight Loss from baseline to the end of the study (time frame: 12 weeks). 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 NCT02348983, which also lists 1 linked publication.
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 30 Jan 2015.