ObesityPIE WHEELNCT03147209
Pilot Intervention-Exercise for the Weight, Healthy Eating, and Exercise for the Long-Haul
A study testing Health Coaching in people with Obesity and Commercial Motor Vehicle Driver, run by University of Utah at 1 site in United States.
Trial summary
Truckers face many unique challenges in their work that may adversely impact their health, including time constraints, sedentary job tasks, and a 'moving-workplace' environment with associated limitations to access healthy food and safe places to be physically active. Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Obesity, Commercial Motor Vehicle Driver
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Dec 2017
- 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 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese (BMI>30kg/m2)
- Working as a commercial motor vehicle driver
Who cannot join
- unable to perform intervention (health coaching and goal setting
Trial locations and contacts
1 site in 1 country.
About this study
Truckers face many unique challenges in their work that may adversely impact their health, including time constraints, sedentary job tasks, and a 'moving-workplace' environment with associated limitations to access healthy food and safe places to be physically active. These issues make it difficult to form and maintain healthy lifestyle habits and contribute to the high prevalence of injuries from both crashes and falls among truckers is supported by an increase in obesity among truckers with longer durations of employment.
The investigators propose to develop and pilot test the Exercise Intervention of the Worksite Health, Eating and Exercising for the Long-haul (WHEEL)'s weight loss intervention. This pilot exercise intervention is aimed at achieving meaningful improvement in grip strength, balance, and gait over 6 weeks. The investigators will use pilot sample of 15 obese (BMI ≥ 30 kg/m2) truckers, documenting changes in these measures. Individualized assessments will be utilized. The investigators will aim to complete the following:
- Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in greater strength comparing baseline with 6 week outcomes.
- Determine the extent to which drivers will participate in PIE WHEEL
- Determine the extent of change in strength, balance and gait realized by PIE WHEEL participation
- Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress and egress related to PIE WHEEL participation
Read the detailed description
Commercial Motor Vehicle Drivers (CMV Drivers), also known as truck drivers, face many unique challenges in their work environment that adversely impact their health, particularly obesity. Obesity is significantly related to CMV driver occupational injuries and deaths from crashes.1, 2 CMV Driver's challenges include time constraints, limited space inside the truck, mostly sedentary job tasks, poor access for parking large trucks, and a 'moving-workplace' environment. This environment has poor access to inexpensive, ready-to-eat, healthy food and places for exercising and showering. These constraints make it difficult to form and maintain healthy lifestyle habits. That these influences likely contribute to the disproportionately high prevalence of obesity among CMV drivers is supported by an increase in obesity among truckers with longer durations of employment.3
Prior efforts to reduce obesity were not successful for trucking.4-7 However two, short-term pilot studies showed promise utilizing motivational interviewing in achieving a 3.5 kg weight loss.8, 9 Accordingly, development of interventions is needed to improve CMV driver's health and safety through weight loss by helping the truck driver's change his/her response to the unique challenges of their work environment.
Herein, The investigators propose the pilot intervention-exercise (PIE) aspect of the Worksite Health, Eating and Exercising for the Long-haul (WHEEL), a behavior-based intervention. The PIE WHEEL will assess the feasibility, acceptability and potential safety improvements of an exercise intervention on quantifiable outcomes that impact workers compensation concerns including musculoskeletal disorders and slips, trips and falls.
PIE WHEEL will utilize health coaches to deliver an intervention using individual goal setting to establish behaviors (exercise only for this pilot study) known to be associated with successful weight loss and/or weight loss maintenance and subsequent safety outcomes designed to meet the challenges of CMV drivers. The investigators will enroll 15 participants for a 6 week exercise intervention.
SPECIFIC AIMS
- Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in greater strength comparing baseline with 6 week outcomes.
- Determine the extent to which drivers will participate in PIE WHEEL
- Determine the extent of change in strength, balance and gait realized by PIE WHEEL participation
- Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress and egress related to PIE WHEEL participation
Safety events (crashes and falls) are a meaningful outcomes in the transportation industry. Some of the causal factors related to these, including strength, vigilance, cardiovascular disease and obesity, may be influences by the PIE WHEEL intervention. This is compounded by the high obesity prevalence, which exceeds >65%, among truckers.10, 11 The personal and public health threat of obesity-related problems among truckers that includes falls and severe injuries are substantial and require intensive intervention efforts to reduce obesity. The investigators propose the PIE WHEEL intervention; a behavior based individualized exercise intervention utilizing health coaches to direct individual goal setting to address this need. This proposal is in direct response to comments from an unfunded R01 intervention that proposed both diet and exercise intervention for weight reduction. The assessment of feasibility, acceptance, and quantification of changes will further strengthen the R01 at the time of resubmission.
- Conditions
- Obesity, Commercial Motor Vehicle Driver
- Being tested
- Health Coaching
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
This intervention will consist of health coaching, goal setting and self directed activities to improve strength and balance.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | This group will undergo coaching and activities to improve strength and balance. Receives: Behavioral: Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Strength
Strength testing will be performed and changes in strength will be evaluated at baseline and after 6 weeks
Measured: 6 weeks
Improved Balance
Balance testing will be performed and changes in balance will be evaluated at baseline and after 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 May 2017
- Primary completion1 Nov 2017
- Study completion1 Dec 2017
Why it stopped: Never received funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a feasibility pilot study for a health coaching intervention for truck drivers
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03147209
- Sponsor's protocol ID
- PPRT-2015-T1
- Acronym
- PIE WHEEL
- Status last verified
- May 2019
- First submitted
- 8 May 2017
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Intervention-Exercise for the Weight, Healthy Eating, and Exercise for the Long-Haul
- ClinicalTrials.gov ID
- NCT03147209
- Acronym / sponsor ID
- PIE WHEEL / PPRT-2015-T1
- Conditions
- Obesity, Commercial Motor Vehicle Driver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never received funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 10 May 2017 (actual)
- 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.
Truckers face many unique challenges in their work that may adversely impact their health, including time constraints, sedentary job tasks, and a 'moving-workplace' environment with associated limitations to access healthy food and safe places to be physically active. These issues make it difficult to form and maintain healthy lifestyle habits and contribute to the high prevalence of injuries from both crashes and falls among truckers is supported by an increase in obesity among truckers with longer durations of employment.
The investigators propose to develop and pilot test the Exercise Intervention of the Worksite Health, Eating and Exercising for the Long-haul (WHEEL)'s weight loss intervention. This pilot exercise intervention is aimed at achieving meaningful improvement in grip strength, balance, and gait over 6 weeks. The investigators will use pilot sample of 15 obese (BMI ≥ 30 kg/m2) truckers, documenting changes in these measures. Individualized assessments will be utilized. The investigators will aim to complete the following:
- Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in greater strength comparing baseline with 6 week outcomes.
- Determine the extent to which drivers will participate in PIE WHEEL
- Determine the extent of change in strength, balance and gait realized by PIE WHEEL participation
- Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress and egress related to PIE WHEEL participation
Detailed description
Commercial Motor Vehicle Drivers (CMV Drivers), also known as truck drivers, face many unique challenges in their work environment that adversely impact their health, particularly obesity. Obesity is significantly related to CMV driver occupational injuries and deaths from crashes.1, 2 CMV Driver's challenges include time constraints, limited space inside the truck, mostly sedentary job tasks, poor access for parking large trucks, and a 'moving-workplace' environment. This environment has poor access to inexpensive, ready-to-eat, healthy food and places for exercising and showering. These constraints make it difficult to form and maintain healthy lifestyle habits. That these influences likely contribute to the disproportionately high prevalence of obesity among CMV drivers is supported by an increase in obesity among truckers with longer durations of employment.3
Prior efforts to reduce obesity were not successful for trucking.4-7 However two, short-term pilot studies showed promise utilizing motivational interviewing in achieving a 3.5 kg weight loss.8, 9 Accordingly, development of interventions is needed to improve CMV driver's health and safety through weight loss by helping the truck driver's change his/her response to the unique challenges of their work environment.
Herein, The investigators propose the pilot intervention-exercise (PIE) aspect of the Worksite Health, Eating and Exercising for the Long-haul (WHEEL), a behavior-based intervention. The PIE WHEEL will assess the feasibility, acceptability and potential safety improvements of an exercise intervention on quantifiable outcomes that impact workers compensation concerns including musculoskeletal disorders and slips, trips and falls.
PIE WHEEL will utilize health coaches to deliver an intervention using individual goal setting to establish behaviors (exercise only for this pilot study) known to be associated with successful weight loss and/or weight loss maintenance and subsequent safety outcomes designed to meet the challenges of CMV drivers. The investigators will enroll 15 participants for a 6 week exercise intervention.
SPECIFIC AIMS
- Evaluate the feasibility of the PIE WHEEL intervention for CMV drivers will result in greater strength comparing baseline with 6 week outcomes.
- Determine the extent to which drivers will participate in PIE WHEEL
- Determine the extent of change in strength, balance and gait realized by PIE WHEEL participation
- Evaluate safety events (crashes, near misses, falls) in the week prior to PIE WHEEL and the final week of PIE WHEEL a. Solicit driver perceptions of their own safety of ingress and egress related to PIE WHEEL participation
Safety events (crashes and falls) are a meaningful outcomes in the transportation industry. Some of the causal factors related to these, including strength, vigilance, cardiovascular disease and obesity, may be influences by the PIE WHEEL intervention. This is compounded by the high obesity prevalence, which exceeds >65%, among truckers.10, 11 The personal and public health threat of obesity-related problems among truckers that includes falls and severe injuries are substantial and require intensive intervention efforts to reduce obesity. The investigators propose the PIE WHEEL intervention; a behavior based individualized exercise intervention utilizing health coaches to direct individual goal setting to address this need. This proposal is in direct response to comments from an unfunded R01 intervention that proposed both diet and exercise intervention for weight reduction. The assessment of feasibility, acceptance, and quantification of changes will further strengthen the R01 at the time of resubmission.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a feasibility pilot study for a health coaching intervention for truck drivers
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingThis group will undergo coaching and activities to improve strength and balance. |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese (BMI>30kg/m2)
- Working as a commercial motor vehicle driver
Key exclusion criteria (1 listed)
- unable to perform intervention (health coaching and goal setting
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 CoachingThis intervention will consist of health coaching, goal setting and self directed activities to improve strength and balance. | Behavioural | Health Coaching |
Primary outcome
Improved Strength
Time frame: 6 weeks
Strength testing will be performed and changes in strength will be evaluated at baseline and after 6 weeks
Improved Balance
Time frame: 6 weeks
Balance testing will be performed and changes in balance will be evaluated at baseline and after 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: No
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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 in people with Obesity and Commercial Motor Vehicle Driver, 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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 May 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Improved Strength (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2019.