"Working for You" Workplace Obesity Intervention

April 5, 2021 updated by: Washington University School of Medicine

Worksite Interventions to Reduce Obesity and Diabetes Risk in Low SES Populations

The purpose of this study is to test a workplace intervention program targeted at low SES workers. Working in partnership with BJC HealthCare, we will test an innovative multi-level intervention that includes an interactive obesity treatment program (iOTA) using SMS text messaging. The iOTA intervention will be embedded in a newly described Healthy Workplace Participatory Program, which incorporates employee participation in decision making to produce changes in the workplace environment that are acceptable, effective, and sustainable. These nested interventions will be tested a large delayed-start group-randomized trial. This study will rigorously test readily scalable interventions that can be translated to other work settings to reduce obesity and diabetes risk among low SES workers, a group at high risk for these disorders. This pragmatic clinical trial will advance the long-term goal of enabling employers and employees to reduce obesity and obesity-associated illnesses including diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific Aim: Test a multi-level worksite weight loss intervention to help workers attain and maintain healthy weight. Investigators propose a new group-level participatory wellness program engaging all employees within intervention work groups. The proposed workplace participatory program will assist work groups to adapt and deploy interventions that change their work environments to support healthy eating and physical activity. Nested within this group-level intervention for all workers, obese (BMI>30) workers will be offered participation in an individual-level interactive obesity treatment approach (iOTA) intervention based on assessment of individual behavior risks, collaborative goal-setting with a health coach, and use of an interactive text system to provide ongoing support and self-monitoring of behavior change goals. Investigators will test these interventions in a delayed-start group randomized trial in 22 work groups (total workers = 990, obese workers = 308).

Specific Aim A: Implement and test a healthy workplace participatory program (HWPP) to promote healthy eating and healthy physical activity among all workers through changes in the work environment. Hypothesis: Workers in intervention groups will show improvements in healthy eating and activity compared to workers in control groups.

Specific Aim B: Implement and test an innovative Individual Obesity Treatment Approach (iOTA) in conjunction with changes in work environment. Hypothesis: Obese workers offered the iOTA intervention will lose weight over 24 month follow-up when compared to obese control group workers.

Study Type

Interventional

Enrollment (Actual)

1283

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All participants must be a member of a chosen work group
  • Speak English
  • At least 18 years of age
  • Sub-group (iOTA Intervention): BMI >=30, cell phone with text messaging capability

Exclusion Criteria:

  • Sub-group (iOTA Intervention): pregnant or nursing, weight-loss surgery in past 12 mths, currently receiving chemotherapy or radiation treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: iOTA and HWPP
Behavioral: iOTA
The Individual Obesity Treatment Approach (iOTA) will assess individual behavior risks, collaborative goal-setting with a health coach, and the use of an interactive text system to provide ongoing support and self-monitoring of behavior change goals.
Behavioral: HWPP
Work groups will participate in the Healthy Workplace Participatory Program (HWPP) to adapt and deploy interventions that change their work environments to support healthy eating and physical activity.
Experimental: HWPP
Behavioral: HWPP
Work groups will participate in the Healthy Workplace Participatory Program (HWPP) to adapt and deploy interventions that change their work environments to support healthy eating and physical activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Weight
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Bradley A Evanoff, MD, MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 5, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201505131
  • R01DK103760 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Investigators will add data to the NIDDK data repository and share it in accordance with the NIDDK data sharing policy upon conclusion of the study.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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