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OpenTrials
Completed

NCT Number: NCT02934113

"Working for You" Workplace Obesity Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iOTA

Behavioral

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.

HWPP

Behavioral

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.

Primary outcomes

  1. Change in Weight

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2016
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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