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Evaluation of Safety and Health Involvement For Truck Drivers (SHIFT)

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ClinicalTrials.gov Identifier: NCT02105571
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : May 16, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryan Olson, Oregon Health and Science University

Brief Summary:
The current project is a randomized, controlled evaluation of a new weight loss and health promotion intervention for truck drivers. The intervention is a 6-month weight loss competition supported with computer based training, behavioral self-monitoring, and motivational interviewing. We hypothesize that the intervention will produce greater change than a usual practices control condition. Our secondary hypothesis is that social support and stress in home and work environments will moderate intervention efficacy.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Intervention Not Applicable

Detailed Description:

Commercial truck drivers have overweight and obesity rates that may be 20% higher than the general population. Obesity has established mortality and disease consequences, including heart disease, diabetes, and sleep apnea. Driver health is also an important safety hazard because obesity and sleep apnea increase the risk of crashes. Drivers experience multiple roadblocks to health, including an isolating job structure that restricts physical activity and dietary choices. Despite the growing health crisis, there is a lack of effective weight loss and health promotion interventions for truck drivers. We therefore developed an intervention that is integrated with the job structure and modern technologies of truck driving. The intervention is a 6-month weight loss competition supported with computer based training, behavioral self-monitoring, and motivational interviewing. The study is a cluster randomized trial where worksites (terminals) will be randomized to intervention and control conditions. We will collect measures from drivers at baseline (month 0), post-intervention (month 6), and one-year follow-up (month 18). The project will take place over five years and accomplish three specific aims:

  1. Determine intervention efficacy for producing changes in diet, exercise, and body weight. Previous weight loss interventions for truck drivers have been minimally effective, and there is a need to evaluate new approaches with randomized, controlled designs. Therefore, we will randomize matched pairs of worksites (terminals) to intervention and control conditions. Drivers at intervention terminals will complete intervention activities over a 6-month period. Drivers at control terminals will receive no treatment during the same time period. Primary outcomes will be changes in body weight, fruit and vegetable consumption, high-saturated fat and high-sugar food consumption, and physical activity.
  2. Determine whether baseline social support and stress moderate intervention efficacy. Although social support and stress have established effects on weight loss with other populations, we know little about the role of social support and stress during interventions for truck drivers. Therefore, we will measure social support and stress in home and work environments at each measurement time point. After the intervention, and again at one-year follow-up, we will test whether social support and stress factors moderated subsequent behavior change and weight loss.
  3. Measure the integrity of each intervention component and model how the intervention worked. We are evaluating a new multi-component intervention with an understudied population. In order to understand how the intervention worked and guide future research, we will measure fidelity and participation in each intervention component and use mediation analyses to determine how the different components affected study outcomes. Analyses will provide an explicit check of the intervention's theoretical underpinnings and assess whether proposed change processes were achieved.

Accomplishing our aims will significantly advance weight loss and health promotion knowledge to the benefit of over 3 million truck drivers in the US, and potentially generalize to 15 million additional workers who spend substantial time alone or traveling for work.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Social Support During a Randomized Trial of a Trucker Weight Loss Intervention
Study Start Date : April 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Intervention activities take place over a 6-month period for each participant, and include a weight loss competition with self-monitoring and feedback; computer-based training units on healthy weight loss, healthy eating, exercise, and sleep; and up to four motivational interviews with a health coach by cell phone.
Behavioral: Intervention
No Intervention: Control
Continued work conditions and "Usual Practices" in that workplace



Primary Outcome Measures :
  1. Change from baseline in body weight at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Directly measured body weight, as well as calculated body mass index based on directly measured height and weight

  2. Change from baseline in dietary behaviors at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey measures of: fruit and vegetable intake; calories from fat; sugary food and drink consumption; fast food consumption

  3. Change from baseline in physical activity at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey and actigraphy measures of physical activity


Secondary Outcome Measures :
  1. Change from baseline in blood pressure at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Direct measurement

  2. Change from baseline in percent body fat at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Direct measurement via Bioelectric Impedance Analysis

  3. Change from baseline in blood lipids and lipoproteins at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Direct measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via Cholestech LDX Analyzer

  4. Change from baseline in blood glucose at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Direct measurement via Cholestech LDX Analyzer

  5. Change from baseline in sleep and fatigue at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Psychomotor Vigilance Task; survey measures of: sleep quality; sleep adequacy; sleep apnea risk

  6. Change from baseline in anthropometric measurements at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Direct measurement of waist-to-hip ratio and neck circumference

  7. Change from baseline in stress at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey measures of: job stress; general life stress; major life events; work-to-family and family-to-work conflict

  8. Change from baseline in social support at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey measures of: social support for diet and exercise from family, friends, coworkers, and others; supervisor support

  9. Change from baseline in self-efficacy at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Self-efficacy for diet and exercise behaviors

  10. Change from baseline in strength and fitness at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Grip strength; 6-minute walk test; hamstring flexibility

  11. Change from baseline in safety outcomes (injuries, crashes, moving violations) at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey measures of injuries, crashes, and moving violations; company records of lost-time injuries, crashes, and moving violations

  12. Change from baseline in driving measures (sudden decelerations, driving over the speed limit, fuel efficiency, safety belt use) at 6 and 18 months [ Time Frame: Baseline, 6 months, 18 months ]
    Survey measures of sudden vehicle decelerations, driving over the speed limit, and safety belt use; Engine computer records of sudden vehicle decelerations, driving over the speed limit, and fuel efficiency



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Truck driver currently employed at a participating company
  • BMI > 27.0

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105571


Locations
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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Publications:
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Responsible Party: Ryan Olson, Scientist, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02105571     History of Changes
Other Study ID Numbers: e3061
R01HL105495 ( U.S. NIH Grant/Contract )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Keywords provided by Ryan Olson, Oregon Health and Science University:
Body Weight
Nutrition
Physical Activity
Sleep
Health Promotion
Stress
Safety