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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • University of Utah

    Salt Lake City, Utah, 84103

Other trials in United States

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 groups in NCT02348983
Study groupRoleWhat they receive
Interventional ArmExperimentalHealth 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.

  1. 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.

  1. First posted28 Jan 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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)
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

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.

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