Worksite Wellness Randomized Controlled Trial

Tufts University

Status: Completed

Conditions: Overweight; Quality of Life; Obesity

Treatments: Behavioral: Human Performance Institute©; Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food; Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher

Study type: Interventional

Funder types: Other

Identifiers

NCT02593240

11768

Details and patient eligibility

About

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.

Enrollment: 554 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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554 participants in 4 patient groups

Human Performance Institute©

Experimental group

Description:

These participants will be part of the intervention sites and will receive the Human Performance Institute© intervention for the duration of the study (18 months).

Treatment:

Behavioral: Human Performance Institute©

The iDiet® with Voucher

Experimental group

Description:

These participants will be part of the intervention sites and will receive the iDiet® with Voucher for the duration of the study (18 months).

Treatment:

Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher

The iDiet® with Food

Experimental group

Description:

These participants will be part of the intervention sites and will receive the iDiet® with Food for the duration of the study (18 months).

Treatment:

Behavioral: The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food

Wait-listed control

No Intervention group

Description:

These participants will be part of the control sites and will participate in outcome assessments for a 6-month period only.