Tufts University Human Nutrition Research Center on Aging
Boston, Massachusetts, 02111, United States
NCT Number: NCT02593240
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.
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Notify Me21 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For those interested in the weight loss intervention, additional exclusion criteria are as follows:
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.
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).
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).
Time frame: 1.5 years
Fasted measurements of weight obtained in duplicate to ±0.1 kg at baseline, 6, 12, and 18 months using the TANITA TBF-300A.
Time frame: 1.5 years
Assessed by the RAND Short Form 36 Health Survey (SF-36) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Systolic and diastolic blood pressure (mm Hg) measured to the nearest 1 mm Hg at baseline, 6, 12, and 18 months using a validated automated monitor (3 fasted measurements, 5 minutes apart, after 5 minutes of quiet sitting).
Time frame: 1.5 years
Total cholesterol, high-density lipoprotein, and low-density lipoprotein measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System, which requires 40 microliters of blood (fasted lipid panel).
Time frame: 1.5 years
Triglycerides measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System (fasted lipid panel).
Time frame: 1.5 years
Fasting blood glucose measured at baseline, 6, 12, and 18 months using the Alere Cholestech LDX® System.
Time frame: 1.5 years
HbA1c measured at baseline, 6, 12, and 18 months using the Siemens DCA Vantage, which requires 1 microliter of blood (fasted measurement).
Time frame: 1.5 years
Assessed by the Food Preferences Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Three-Factor Eating Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Food Cravings Questionnaire - Trait (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Center for Epidemiological Studies Depression Scale (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Profile of Mood States (self-administered) at baseline, 6, 12, and 18 months. Variables include anger-hostility, depression-dejection, fatigue-inertia, and vigor-activity.
Time frame: 1.5 years
Assessed by the International Physical Activity Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Ryff Purpose in Life scale (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Work Productivity and Impairment scale (self-administered) at baseline, 6, 12, and 18 months.
Time frame: 1.5 years
Assessed by the Medical Outcomes Study Sleep Questionnaire (self-administered) at baseline, 6, 12, and 18 months.
Tufts University
Other
Worksite Wellness Study
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