Clinical trial NCT02105571: Evaluation of Safety and Health Involvement For Truck Drivers
Official title: Social Support During a Randomized Trial of a Trucker Weight Loss Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Body Weight
Nutrition
Physical Activity
Sleep
Health Promotion
Stress
Safety
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2014-04-07
Enrollment: 472
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Truck driver currently employed at a participating company
* BMI \> 27.0

Exclusion Criteria:

* None

Primary outcomes:
measure: Change from baseline in body weight at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in dietary behaviors at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in physical activity at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
Secondary outcomes:
measure: Change from baseline in blood pressure at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in percent body fat at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in blood lipids and lipoproteins at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in blood glucose at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in sleep and fatigue at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in anthropometric measurements at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in stress at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in social support at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in self-efficacy at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in strength and fitness at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in safety outcomes (injuries, crashes, moving violations) at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
measure: Change from baseline in driving measures (sudden decelerations, driving over the speed limit, fuel efficiency, safety belt use) at 6 and 18 months
timeFrame: Baseline, 6 months, 18 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
citation: Olson R, Anger WK, Elliot DL, Wipfli B, Gray M. A new health promotion model for lone workers: results of the Safety & Health Involvement For Truckers (SHIFT) pilot study. J Occup Environ Med. 2009 Nov;51(11):1233-46. doi: 10.1097/JOM.0b013e3181c1dc7a.
citation: Wipfli B, Olson R, Koren M. Weight-loss maintenance among SHIFT pilot study participants 30-months after intervention. J Occup Environ Med. 2013 Jan;55(1):1-3. doi: 10.1097/JOM.0b013e31827db848. No abstract available.