NCT02348983

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

January 16, 2015

Last Update Submit

January 28, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measured Weight Loss from baseline to the end of the study

    Difference in measured weight from baseline to the end of the study.

    12 weeks

Study Arms (1)

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.

Behavioral: Health Coaching via Telephone

Interventions

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.

Interventional Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
* Participants will be screened for eligibility based on: * Age \> 21 * BMI \> 30 kg/m2 * No reported unstable chronic disease. * 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. Inclusion of women 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. Inclusion of minorities 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. Inclusion of Children Commercial truck drivers must be 21 to drive interstate routes. Therefore, children, including those 18-20 years old, will not be included.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84103, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 28, 2015

Study Start

January 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations