Worksite Wellness Randomized Controlled Trial



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - Any
Updated:4/26/2018
Start Date:October 2015
End Date:March 2018

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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 combination of 2 interventions will be tested
against the control condition in an intention to treat model and with a completers analysis.


Inclusion Criteria:

1. Willingness to sign an informed consent form

2. Willingness to provide release from his/her physician before starting the intervention
program-a requirement for each of the 3 wellness programs

3. Willingness to provide email identification (ID) and contact information to the
commercial program facilitators to receive program materials and other feedback
related to program progress

4. Willingness to complete outcome assessments and self-monitoring in order to track
intervention effectiveness

5. BMI ≥ 20 kg/m2 and < 50 kg/m2 at screening, if participant opts into the HPI arm

6. BMI ≥ 25 kg/m2 and < 50 kg/m2 at screening, if participant opts into the weight loss
arm

Exclusion Criteria:

1. Employees who are temporary contract workers or employees who work remotely most of
the time

2. < 21 years of age

3. Participation in a weight loss program or intensive wellbeing program at time of
enrollment

4. Pregnant or lactating (per self-reports, now or intended during study)

5. Prior weight loss surgery or a medical complication that would prevent full
participation

6. Multiple severe dietary intolerances (e.g. gluten combined with dairy or meat) which
would reduce intervention adherence

7. Non-English speaking

8. Individuals who have lost > 15 pounds in the past 6 months

9. Mobility limitations (inhibiting the ability to stand on one's own or get on and off
of the scale)

10. Major diseases including active cancer or cardiovascular disease

11. BMI < 25 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the weight-loss
group

12. BMI <20 kg/m2 or ≥ 50 kg/m2 at screening, for those that opt-in to the HPI group

For those interested in the weight loss intervention, additional exclusion criteria
are as follows:

13. Any condition that influences the ability to absorb food (e.g. inflammatory bowel
disease or celiac disease)

14. Very active individuals (> 2 hours/day or >14 hours/week of vigorous activity).
We found this trial at
1
site
Boston, Massachusetts 02111
Principal Investigator: Susan B Roberts, PhD
Phone: 617-556-3313
?
mi
from
Boston, MA
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