Clinical trial NCT02593240: Worksite Wellness Randomized Controlled Trial
Official title: Worksite Wellness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Quality of Life
Keywords: Energy
Presenteeism
Absenteeism
Cardiometabolic health
Obesity
Overweight
Weight Loss
Quality of Life
Weight Control
Eating Behavior
Food Cravings
Hunger
Worksite Wellness
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 554
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Weight (iDiet/Healthy Weight for Living arms)
timeFrame: 1.5 years
measure: Quality of Life (HPI arm)
timeFrame: 1.5 years
Secondary outcomes:
measure: Blood pressure
timeFrame: 1.5 years
measure: Cholesterol
timeFrame: 1.5 years
measure: Triglycerides
timeFrame: 1.5 years
measure: Glucose
timeFrame: 1.5 years
measure: Hemoglobin A1c
timeFrame: 1.5 years
measure: Eating behavior (Food Preferences)
timeFrame: 1.5 years
measure: Eating behavior (Three-Factor Eating)
timeFrame: 1.5 years
measure: Eating behavior (Food Cravings)
timeFrame: 1.5 years
measure: Depression
timeFrame: 1.5 years
measure: Mood
timeFrame: 1.5 years
measure: Physical Activity
timeFrame: 1.5 years
measure: Well-being
timeFrame: 1.5 years
measure: Productivity
timeFrame: 1.5 years
measure: Sleep
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University Human Nutrition Research Center on Aging
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Sai Krupa Das, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts University
name: Susan B Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
References: