NCT02105571

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
472

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable obesity

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

April 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 16, 2018

Status Verified

May 1, 2018

Enrollment Period

4 years

First QC Date

February 28, 2014

Last Update Submit

May 10, 2018

Conditions

Keywords

Body WeightNutritionPhysical ActivitySleepHealth PromotionStressSafety

Outcome Measures

Primary Outcomes (3)

  • Change from baseline in body weight at 6 and 18 months

    Directly measured body weight, as well as calculated body mass index based on directly measured height and weight

    Baseline, 6 months, 18 months

  • Change from baseline in dietary behaviors at 6 and 18 months

    Survey measures of: fruit and vegetable intake; calories from fat; sugary food and drink consumption; fast food consumption

    Baseline, 6 months, 18 months

  • Change from baseline in physical activity at 6 and 18 months

    Survey and actigraphy measures of physical activity

    Baseline, 6 months, 18 months

Secondary Outcomes (12)

  • Change from baseline in blood pressure at 6 and 18 months

    Baseline, 6 months, 18 months

  • Change from baseline in percent body fat at 6 and 18 months

    Baseline, 6 months, 18 months

  • Change from baseline in blood lipids and lipoproteins at 6 and 18 months

    Baseline, 6 months, 18 months

  • Change from baseline in blood glucose at 6 and 18 months

    Baseline, 6 months, 18 months

  • Change from baseline in sleep and fatigue at 6 and 18 months

    Baseline, 6 months, 18 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Continued work conditions and "Usual Practices" in that workplace

Interventions

InterventionBEHAVIORAL
Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • 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.

    PMID: 19858740BACKGROUND
  • 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.

    PMID: 23291953BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

ObesityBody WeightMotor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

February 28, 2014

First Posted

April 7, 2014

Study Start

April 1, 2011

Primary Completion

April 1, 2015

Study Completion

March 1, 2017

Last Updated

May 16, 2018

Record last verified: 2018-05

Locations