NCT02593240

Worksite Wellness Randomized Controlled Trial

Worksite Wellness Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

Worksites offer attractive locations for reducing the national prevalence of overweight and obesity. Interventions that are both effective and sustainable for producing long-term changes in health and employee wellness are urgently needed. In an 18-month worksite randomized controlled trial in 12 worksites, this study will test two lifestyle approaches designed to facilitate behavior modification for achieving long-term improvements in health and quality of life. Worksites randomized to the immediate intervention arm will receive the two on-site wellness programs and the randomized control sites will participate in outcomes assessments for the initial 6-month period, after which participants will receive vouchers to participate in the program of their choice. The primary focus of the worksite wellness study is to identify ways to improve health-related quality of life, with a particular focus on a decrease in cardiometabolic risk factors, including weight, improved weight-related wellness, and improved energy level in work and life. The two interventions will be separately tested against the control condition in intention-to-treat models and with a completers analysis.

Conditions

• Obesity
• Overweight
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food	The intensive iDiet® group behavioral weight loss program will be delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the iDiet® intervention will be randomized to receive commercial dried food products (partial supply) from Yevo Intl., which are designed to help with weight control and health.
BEHAVIORAL	The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher	The intensive iDiet® group behavioral weight loss program delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the Diet® intervention will be randomized to receive gift cards monthly for the first 6 months to purchase foods at their local grocery store (partial costs).
BEHAVIORAL	Human Performance Institute©	The Human Performance Institute© (HPI) training workshop is a comprehensive individual development training program that focuses on the concept of energy management. The primary aim of this program is to help individuals develop attitudes, habits, and behaviors that increase their levels of daily energy, life satisfaction, and overall functioning. The course is delivered at an off-site location over 2.5 days, by 3 coaches, in a group format of 25 - 32 participants (with employees from more than one worksite per group).

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-11-02
• Last updated: 2020-08-27

Locations

1 site across 1 country: United States