Obesity Clinical Trial
Official title:
Environmental Approaches for Obesity Management at Dow
The purpose of this study is to design and demonstrate the feasibility of implementing moderate and intensive environmental obesity prevention programs at major worksites.
BACKGROUND:
More than half of all Americans are overweight or obese, and the prevalence of these risk
factors has increased dramatically in the past decade. Obesity is a risk factor for several
chronic illnesses, including type 2 diabetes and heart disease. The national medical cost
that is attributed to obesity is estimated to be between $60 and $93 billion. Business
leaders are becoming increasingly aware of the human and economic burden that poor health
imposes on their workers. Many employers have invested in health promotion and disease
prevention programs aimed at reducing the prevalence of obesity in the workplace through the
encouragement of physical activity, maintaining a healthy diet, and improved management of
health risk factors. Employers continue to seek innovative and evidence-based programs that
can be implemented in the workplace to address a growing public health epidemic that also
adversely affects worker productivity.
DESIGN NARRATIVE:
The primary objective of this study will be to evaluate the effect of introducing two levels
of environmental programs, in addition to existing individualized programs, at reducing
obesity in the workplace. Five outcomes will be evaluated: 1) body mass index and other
weight-related biometric measures; 2) behavioral health risk factors; 3) weight-related
health conditions; 4) health care utilization and medical expenditures; and 5) employee
productivity measured in terms of reduced absenteeism and on-the-job presenteeism. The study
will also include an assessment of costs and benefits of the two programs, including the
medical, absenteeism, and productivity benefits, and an assessment of the impact of the
programs on the worksite climate. Twelve Dow chemical companies will participate in the
study. Participants will be randomly assigned to a moderate environmental program, an
intensive environmental program, or a control group, which will receive individualized
treatment only. The moderate program will include inexpensive environmental changes (e.g.,
prompts and reminders). In the high intensity program, senior managers will assist in the
development of a worksite culture that is broadly supportive of improved weight and health
management by employees. Annual health screening and biometrics data along with
administrative medical claims, absence records, and productivity survey data will be
analyzed to determine program impacts. Non-experimental statistical methods will be used to
control the differences that remain across sites after randomization. The study will also
produce extensive information about how employers can successfully implement environmental
programs to reduce obesity at worksites.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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