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ObesitySHIFTNCT02105571

Evaluation of Safety and Health Involvement For Truck Drivers

A study testing Intervention in people with Obesity, run by Oregon Health and Science University 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

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. 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?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
1 siteUnited States
Study dates
23 Apr 2012to Apr 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Health and Science University

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Social Support During a Randomized Trial of a Trucker Weight Loss Intervention

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.

Read the 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.

Conditions
Obesity
Being tested
Intervention
Keywords
Body Weight, Nutrition, Physical Activity, Sleep, Health Promotion, Stress, Safety
Medical subject headings
Obesity, Body Weight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02105571
Study groupRoleWhat they receive
InterventionExperimentalIntervention 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.
Receives: Behavioral: Intervention
ControlNo interventionContinued work conditions and "Usual Practices" in that workplace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Body Weight (lb) at 6 Months

    Directly measured body weight in lb, collected at baseline and 6 months.

    Measured: Baseline, 6 months

  2. Change From Baseline in Body Weight (lb) at 18 Months

    Directly measured body weight in lb, collected at baseline and 18 months.

    Measured: Baseline, 18 months

  3. Change From Baseline in Body Mass Index at 6 Months

    Calculated from directly measured weight and height (kg/m^2) at baseline and at 6 months.

    Measured: Baseline, 6 Months

  4. Change From Baseline in Body Mass Index at 18 Months

    Calculated from directly measured weight and height (kg/m^2) at baseline and at 18 months.

    Measured: Baseline, 18 Months

  5. Change From Baseline in Daily Fruit or Vegetable Servings at 6 Months

    Survey measures of fruit and vegetable intake (National Cancer Institute Fruit and Vegetable Intake Screener; range: number of servings per day). Collected at baseline and at 6 months.

    Measured: Baseline, 6 Months

  6. Change From Baseline in Daily Fruit or Vegetable Servings at 18 Months

    Survey measures of fruit and vegetable intake (National Cancer Institute Fruit and Vegetable Intake Screener; range: number of servings per day). Collected at baseline and at 18 months.

    Measured: Baseline, 18 Months

  7. Change From Baseline in Percent Energy From Fat at 6 Months

    Survey measure resulting in an estimate of the percentage of calories/energy from fat (using the NCI 16 item dietary fat screener). Collected at baseline and at 6 months.

    Measured: Baseline, 6 Months

  8. Change From Baseline in Percent Energy From Fat at 18 Months

    Survey measure resulting in an estimate of the percentage of calories/energy from fat (using the NCI 16 item dietary fat screener). Collected at baseline and at 18 months.

    Measured: Baseline, 18 Months

  9. Change From Baseline in Sugary Snack Consumption at 6 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 6 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 6 Months

  10. Change From Baseline in Sugary Snack Consumption at 18 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 18 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 18 Months

  11. Change From Baseline in Sugary Drink Consumption at 6 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 6 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 6 Months

  12. Change From Baseline in Sugary Drink Consumption at 18 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 18 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 18 Months

  13. Change From Baseline in Fast Food Consumption at 6 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 6 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 6 months

  14. Change From Baseline in Fast Food Consumption at 18 Months

    Survey measure of the frequency of sugary snack consumption (0-9, where 0 is best and 9 is worst). Surveyed at baseline and at 18 months: (0-1, never-less than once | 2, 1-3 times in a month | 3, 1-2 times per week | 4, 3-4 times per week | 5, 5-6 times per week | 6, Once a day | 7, 2 times per day | 8, 3-4 times per day | 9, 5 or more times per day).

    Measured: Baseline, 18 months

  15. Change From Baseline in Physical Activity at 6 Months

    We scored the healthy physical activity scale as the mean of 4 questions assessing days per week (0-7) with 30 min of moderate or vigorous aerobic activity, or any strength training. Calculated at baseline and at 6 months.

    Measured: Baseline, 6 months

  16. Change From Baseline in Physical Activity at 18 Months

    We scored the healthy physical activity scale as the mean of 4 questions assessing days per week (0-7) with 30 min of moderate or vigorous aerobic activity, or any strength training. Calculated at baseline and at 18 months.

    Measured: Baseline, 18 months

Secondary outcomes (20)
  1. Change From Baseline in Sleep Quality at 6 Months

    Survey measure of the global Pittsburgh Sleep Quality Index (Possible Scores: 0 to 21, 0 being the best). Calculated at baseline and at 6 months.

    Measured: Baseline, 6 months

  2. Change From Baseline in Sleep Quality at 18 Months

    Survey measure of the global Pittsburgh Sleep Quality Index (Possible Scores: 0 to 21, 0 being the best). Calculated at baseline and at 18 months.

    Measured: Baseline, 18 months

  3. Change From Baseline in Self-reported Sleep Duration at 6 Months

    Self-reported typical sleep duration in hours. Collected at baseline and 6 months.

    Measured: Baseline, 6 Months

  4. Change From Baseline in Self-reported Sleep Duration at 18 Months

    Computed self-reported typical sleep duration in hours using reported time in bed minus time reported to fall asleep. The original 6-month outcome measure did not subtract the time reported to fall asleep from the overall difference, resulting in slightly higher baseline and 6-month estimated means for sleep duration. Calculated at baseline and 18 months.

    Measured: Baseline, 18 months

  5. Change From Baseline in Driving Safety Incidents at 6 Months

    Sum of the scores of 3 subscales asking about the number of moving violations, curb strikes, and collisions with property damage. The total range goes from 0 to 15, with lower scores meaning less incidents (moving violations, curb strikes, and collisions with property damage). The subscales include the following: "In the past 6 months, have you been cited for any moving violations?" (Scale from 0-5: 0 = no moving violations | 1 = yes, 1 moving violation | 2 = yes, 2 moving violations | 3 = yes, 3 moving violations | 4 = yes, 4 moving violations | 5 = yes, 5 or more moving violations). "In the past 6 months, how many times have you struck a curb or object with your truck with no property damage?" (Scale from 0-5, 0 = no times and 5 = 5 or more). "In the past 6 months, how many times have you had a collision that resulted in property damage, injury, or death?" (Scale from 0-5, 0 = no times and 5 = 5 or more). Surveyed at baseline and at 6 months.

    Measured: Baseline, 6 Months

  6. Change From Baseline in Driving Safety Incidents at 18 Months

    Sum of the scores of 3 subscales asking about the number of moving violations, curb strikes, and collisions with property damage. The total range goes from 0 to 15, with lower scores meaning less incidents (moving violations, curb strikes, or collisions with property damage). The subscales include the following: "In the past 6 months, have you been cited for any moving violations?" (Scale from 0-5: 0 = no moving violations | 1 = yes, 1 moving violation | 2 = yes, 2 moving violations | 3 = yes, 3 moving violations | 4 = yes, 4 moving violations | 5 = yes, 5 or more moving violations). "In the past 6 months, how many times have you struck a curb or object with your truck with no property damage?" (Scale from 0-5, 0 = no times and 5 = 5 or more). "In the past 6 months, how many times have you had a collision that resulted in property damage, injury, or death?" (Scale from 0-5, 0 = no times and 5 = 5 or more). Surveyed at baseline and at 18 months.

    Measured: Baseline, 18 Months

  7. Change From Baseline in Days Missed Because of Illness and Injury at 6 Months

    Sum of the scores of 2 subscales asking for the number of total work days missed due to illness ("In the past 6 months, have you missed work for illness or personal reasons (cold/flu/infection, child or parent care, not feeling well, etc.)?") and injury ("If you had 1 or more injuries at work that required you to miss work on following shifts, how many total work days did you miss?"). Answers are on a 6-point scale, with responses assigned scores from 0 to 5 (0 = no missed days | 1 = yes, 1 day | 2 = yes, 2 days | 3 = yes, 3-5 days | 4 = yes, 6-10 days | 5 = yes, 10 or more days). The total sum of the two scores ranges from 0 to 10, with lower scores meaning less days missed due to either illness or injury. Surveyed at baseline and at 6 months.

    Measured: Baseline, 6 months

  8. Change From Baseline in Days Missed Because of Illness or Injury at 18 Months

    Sum of the scores of 2 subscales asking for the number of total work days missed due to illness ("In the past 6 months, have you missed work for illness or personal reasons (cold/flu/infection, child or parent care, not feeling well, etc.)?") and injury ("If you had 1 or more injuries at work that required you to miss work on following shifts, how many total work days did you miss?"). Answers are on a 6-point scale, with responses assigned scores from 0 to 5 (0 = no missed days | 1 = yes, 1 day | 2 = yes, 2 days | 3 = yes, 3-5 days | 4 = yes, 6-10 days | 5 = yes, 10 or more days). The total sum of the two scores ranges from 0 to 10, with lower scores meaning less days missed due to either illness or injury. Surveyed at baseline and at 18 months.

    Measured: Baseline, 18 months

  9. Change From Baseline in Waist Circumference at 6 Months

    Measured waist circumference in centimeters at baseline and at 6 months.

    Measured: Baseline, 6 months

  10. Change From Baseline in Waist Circumference at 18 Months

    Measured waist circumference in centimeters at baseline and at 18 months.

    Measured: Baseline, 18 Months

  11. Change From Baseline in Waist-to-hip Ratio at 6 Months

    Calculated waist-to-hip ratio by dividing waist circumference (cm) with hip circumference (cm). Done at baseline and at 6 months.

    Measured: Baseline, 6 months

  12. Change From Baseline in Waist-to-hip Ratio at 18 Months

    Calculated waist-to-hip ratio by dividing waist circumference (cm) with hip circumference (cm). Done at baseline and at 18 months.

    Measured: Baseline, 18 months

  13. Change From Baseline in Percent Body Fat at 6 Months

    Direct measurement via Bioelectric Impedance Analysis. Collected at baseline and at 6 months.

    Measured: Baseline, 6 months

  14. Change From Baseline in Percent Body Fat at 18 Months

    Direct measurement via Bioelectric Impedance Analysis. Collected at baseline and at 18 months.

    Measured: Baseline, 18 months

  15. Change From Baseline in Blood Pressure at 6 Months

    Direct measurement in mmHg. Recorded and analyzed as Systolic and Diastolic BP separately. Collected at baseline and 6 months.

    Measured: Baseline, 6 months

  16. Change From Baseline in Blood Pressure at 18 Months

    Direct measurement in mmHg. Recorded and analyzed as Systolic and Diastolic BP separately. Collected at baseline and 18 months.

    Measured: Baseline, 18 months

  17. Change From Baseline in Blood Lipids and Lipoproteins at 6 Months

    Direct measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via Cholestech LDX Analyzer. Collected at baseline and at 6 months.

    Measured: Baseline, 6 months

  18. Change From Baseline in Blood Lipids and Lipoproteins at 18 Months

    Direct measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via Cholestech LDX Analyzer. Collected at baseline and at 18 months.

    Measured: Baseline, 18 months

  19. Change From Baseline in Blood Glucose Risk at 6 Months

    Blood glucose measurement collected via Cholestech LDX Analyzer. We categorized blood glucose scores as moderate or high risk using established cut-off criteria for abnormal values based on fasting compliance (fasting or random). We coded blood glucose risk as 1 for those at elevated risk (fasting >=100 mg/dl, random >= 200 mg/dl) and 0 for normal glucose values (fasting < 100 mg/dl, random < 200 mg/dl. Calculated at baseline and at 6 months.

    Measured: Baseline, 6 months

  20. Change From Baseline in Blood Glucose Risk at 18 Months

    Blood glucose measurement collected via Cholestech LDX Analyzer. We categorized blood glucose scores as moderate or high risk using established cut-off criteria for abnormal values based on fasting compliance (fasting or random). We coded blood glucose risk as 1 for those at elevated risk (fasting >=100 mg/dl, random >= 200 mg/dl) and 0 for normal glucose values (fasting < 100 mg/dl, random < 200 mg/dl. Calculated at baseline and at 18 months.

    Measured: Baseline, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2014 (estimated)
  2. Study start23 Apr 2012
  3. Primary completion6 Feb 2015
  4. Study completionApr 2017

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02105571
Sponsor's protocol ID
e3061
Other IDs
R01HL105495
Acronym
SHIFT
Status last verified
Sep 2026
First submitted
28 Feb 2014
Last updated
28 Oct 2026
Data monitoring committee
No

Publications

  • Olson R, Wipfli B, Hanson GC, Bodner T, Anger WK, Elliot DL, Mansfield L. Weight loss maintenance among truck drivers in the SHIFT randomised controlled trial, USA. Occup Environ Med. 2025 Jul 9;82(4):168-175. doi: 10.1136/oemed-2024-109903.

    PubMed 40355262
  • Olson R, Wipfli B, Thompson SV, Elliot DL, Anger WK, Bodner T, Hammer LB, Perrin NA. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States. Am J Public Health. 2016 Sep;106(9):1698-706. doi: 10.2105/AJPH.2016.303262. Epub 2016 Jul 27.

    PubMed 27463067

Questions about this trial

What is this clinical trial studying?

A study testing Intervention in people with Obesity, run by Oregon Health and Science University 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: finished, as of the sponsor's last update on 28 Oct 2026. 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?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Body Weight (lb) at 6 Months (time frame: Baseline, 6 months). The study lists 16 primary outcomes in all. 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 NCT02105571, which also lists 2 linked publications.

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 28 Oct 2026.

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