Worksite Wellness Randomized Controlled Trial

NCT ID: NCT02593240

Last Updated: 2020-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 554 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-03-31

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.

Conditions

Obesity; Overweight; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human Performance Institute©

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).

Group Type: EXPERIMENTAL

Human Performance Institute©

Intervention Type: BEHAVIORAL

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).

The iDiet® with Voucher

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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 iDiet® with Food

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

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

Wait-listed control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

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

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Sai Krupa Das

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sai Krupa Das, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Susan B Roberts, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University

Locations

Tufts University Human Nutrition Research Center on Aging

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11768

Identifier Type: -

Identifier Source: org_study_id